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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01802788
Registration number
NCT01802788
Ethics application status
Date submitted
21/02/2013
Date registered
1/03/2013
Date last updated
10/06/2024
Titles & IDs
Public title
5 Year Observation of Patients With PORTICO Valves
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Scientific title
International Long-term Follow-up Study of Patients Implanted With a Portico™ Valve
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Secondary ID [1]
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CV-12-054-EU-PV
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Universal Trial Number (UTN)
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Trial acronym
PORTICO-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - St Jude Medical Portico replacement aortic valve
Treatment: Surgery - Transcatheter Aortic Valve Implant
Cohort A - Patients implanted with a Portico valve after CE mark
Cohort B - Patients implanted in previous SJM-sponsored premarket studies
Treatment: Devices: St Jude Medical Portico replacement aortic valve
Treatment: Surgery: Transcatheter Aortic Valve Implant
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With All-cause Mortality
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Assessment method [1]
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Percentage of participants that died for any reason at 1 year post implantation
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Timepoint [1]
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1 year post implant
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Secondary outcome [1]
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Percentage of Participants With All Cause Mortality in Cohort A
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Assessment method [1]
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Percentage of participants that died for any reason at 30 days through 5 years post implantation
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Timepoint [1]
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30 days through 5 years post implant
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Secondary outcome [2]
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Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B
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Assessment method [2]
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Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.
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Timepoint [2]
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30 days through 5 years post implant
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Secondary outcome [3]
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Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [3]
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Percentage of participants that died for cardiovascular or unknown reasons as defined by VARC-2 at 30 days through 5 years post implantation
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Timepoint [3]
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30 days through 5 years post implant
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Secondary outcome [4]
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Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
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Assessment method [4]
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Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.
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Timepoint [4]
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30 days through 5 years post implant
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Secondary outcome [5]
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Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [5]
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Percentage of participants that died for any reason at 30 days through 5 years post implantation
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Timepoint [5]
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30 days through 5 years post implant
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Secondary outcome [6]
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Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
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Assessment method [6]
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Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.
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Timepoint [6]
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30 days through 5 years post implant
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Secondary outcome [7]
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Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [7]
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Percentage of participants with a myocardial infarction as defined by VARC-2 at 30 days through 5 years post implantation post implantation
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Timepoint [7]
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30 days through 5 years post implant
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Secondary outcome [8]
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Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
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Assessment method [8]
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Number of participants with a myocardial infarction as defined by VARC-2 at 30 days through 5 years post implantation post implantation
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Timepoint [8]
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30 days through 5 years post implant
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Secondary outcome [9]
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Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [9]
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Percentage of participants with vascular access site complication (major or minor) as defined by VARC-2 at 30 days post implantation
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Timepoint [9]
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30 days post implant
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Secondary outcome [10]
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Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [10]
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Percentage of participants with a bleeding events (life threatening, major or minor) as defined by VARC-2 at 30 days post implantation
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Timepoint [10]
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30 days post implant
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Secondary outcome [11]
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Percentage of Participants With Stage 1, 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [11]
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Percentage of participants with a Stage 1, 2 or Stage 3 acute kidney injury as defined by VARC-2 at 30 days post implantation
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Timepoint [11]
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30 days post implant
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Secondary outcome [12]
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Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)
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Assessment method [12]
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The aortic valve area as interpreted by an independent echocardiographic core laboratory at 30 days through 5 years post implantation
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Timepoint [12]
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30 days through 5 years post implant
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Secondary outcome [13]
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Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)
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Assessment method [13]
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The mean transvalvular gradient as interpreted by an independent echocardiographic core laboratory at 30 days through 5 years post implantation
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Timepoint [13]
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30 days through 5 years post implant
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Secondary outcome [14]
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Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
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Assessment method [14]
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The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
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Timepoint [14]
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30 days post implant
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Secondary outcome [15]
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Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
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Assessment method [15]
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The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
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Timepoint [15]
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1 year post implant
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Secondary outcome [16]
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Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
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Assessment method [16]
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The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
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Timepoint [16]
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2 years post implant
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Secondary outcome [17]
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Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
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Assessment method [17]
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The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
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Timepoint [17]
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3 years post implant
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Secondary outcome [18]
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Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
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Assessment method [18]
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The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
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Timepoint [18]
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4 years post implant
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Secondary outcome [19]
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Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
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Assessment method [19]
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The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
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Timepoint [19]
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5 years post implant
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Secondary outcome [20]
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Mean Six Minute Walk Test (6MWT)
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Assessment method [20]
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Distance in metres that the participant can walk in 6 minutes. The six-minute walking test (6MWT) is a commonly used objective measure of functional exercise capacity in individuals with moderately severe impairment.
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Timepoint [20]
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30 days through 5 years post implant
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Secondary outcome [21]
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Mean Quality of Life Assessment in Cohort A
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Assessment method [21]
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EuroQuol-5 Dimensions (EQ5D) is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. This scale ranges between 0-100, where 0 is 'the worst health you can imagine' and 100 is 'the best health you can imagine'.
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Timepoint [21]
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30 days and 1 year post implant
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Secondary outcome [22]
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Percentage of Participants With Transient Ischemic Attack in Cohort A
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Assessment method [22]
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Percentage of participants with transient ischemic attack as defined by VARC-2 at 30 days through 5 years post implantation
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Timepoint [22]
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30 days through 5 years post implantation
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Secondary outcome [23]
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Number of Participants With Transient Ischemic Attack in Cohort B
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Assessment method [23]
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Number of participants with transient ischemic attack as defined by VARC-2 at 30 days through 5 years post implantation
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Timepoint [23]
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30 days through 5 years post implantation
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Secondary outcome [24]
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Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [24]
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Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 30 days post implantation
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Timepoint [24]
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30 days post implant
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Secondary outcome [25]
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Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [25]
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Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 1 year post implantation
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Timepoint [25]
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1 year post implant
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Secondary outcome [26]
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Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [26]
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Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 2 years post implantation
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Timepoint [26]
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2 years post implant
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Secondary outcome [27]
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Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [27]
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Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 3 years post implantation
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Timepoint [27]
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3 years post implant
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Secondary outcome [28]
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Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [28]
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Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 4 years post implantation
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Timepoint [28]
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4 years post implant
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Secondary outcome [29]
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Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [29]
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Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 5 years post implantation
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Timepoint [29]
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5 years post implant
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Secondary outcome [30]
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Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
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Assessment method [30]
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Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 2 years post implantation
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Timepoint [30]
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2 years post implant
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Secondary outcome [31]
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Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
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Assessment method [31]
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Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 3 years post implantation
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Timepoint [31]
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3 years post implant
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Secondary outcome [32]
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Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
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Assessment method [32]
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Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 4 years post implantation
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Timepoint [32]
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4 years post implant
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Secondary outcome [33]
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Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
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Assessment method [33]
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Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 5 years post implantation
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Timepoint [33]
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5 years post implant
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Secondary outcome [34]
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Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [34]
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Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 30 days post implantation
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Timepoint [34]
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30 days post implant
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Secondary outcome [35]
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Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [35]
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Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 1 year post implantation
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Timepoint [35]
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1 year post implant
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Secondary outcome [36]
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Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [36]
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Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 2 years post implantation
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Timepoint [36]
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2 years post implant
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Secondary outcome [37]
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Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [37]
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Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 3 years post implantation
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Timepoint [37]
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3 years post implant
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Secondary outcome [38]
0
0
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [38]
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Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 4 years post implantation
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Timepoint [38]
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4 years post implant
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Secondary outcome [39]
0
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Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
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Assessment method [39]
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Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 5 years post implantation
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Timepoint [39]
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5 years post implant
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Secondary outcome [40]
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0
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
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Assessment method [40]
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Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 2 years post implantation
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Timepoint [40]
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2 years post implant
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Secondary outcome [41]
0
0
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
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Assessment method [41]
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0
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 3 years post implantation
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Timepoint [41]
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3 years post implant
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Secondary outcome [42]
0
0
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
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Assessment method [42]
0
0
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 4 years post implantation
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Timepoint [42]
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4 years post implant
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Secondary outcome [43]
0
0
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
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Assessment method [43]
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0
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 5 years post implantation
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Timepoint [43]
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0
5 years post implant
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Secondary outcome [44]
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Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
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Assessment method [44]
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Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 30 days post implantation
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Timepoint [44]
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30 days post implant
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Secondary outcome [45]
0
0
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
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Assessment method [45]
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Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 1 year post implantation
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Timepoint [45]
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1 year post implant
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Secondary outcome [46]
0
0
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
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Assessment method [46]
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Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 2 years post implantation
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Timepoint [46]
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0
2 years post implant
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Secondary outcome [47]
0
0
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
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Assessment method [47]
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0
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 3 years post implantation
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Timepoint [47]
0
0
3 years post implant
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Secondary outcome [48]
0
0
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
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Assessment method [48]
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0
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 4 years post implantation
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Timepoint [48]
0
0
4 years post implant
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Secondary outcome [49]
0
0
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
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Assessment method [49]
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0
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 5 years post implantation
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Timepoint [49]
0
0
5 years post implant
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Eligibility
Key inclusion criteria
- Patient has signed the Patient Informed Consent prior to participating in the clinical
investigation.
- Patient has been referred for a Portico Valve implant as per Heart Team decision or
patient has received a Portico Valve as per participation in an SJM sponsored
regulatory or first-in-human trial.
- Patient has senile degenerative aortic valve stenosis confirmed by
echocardiographically derived criteria*:
- An initial aortic valve area (AVA) of less than or equal to (=) 1.0 cm2 (or
indexed EOA less than or equal to (=) 0.6 cm2/m2) AND
- A mean gradient greater than (>)40 mmHg or jet velocity greater than (>)4.0 m/s
or Doppler Velocity Index less than (<)0.25. If the mean gradient is <40 mmHg and
left ventricular ejection fraction (LVEF) <55%, then the site may as well perform
a dobutamine stress echo to see if the mean gradient increases to >40 mmHg."
(Baseline measurement taken by echo within 6 months of index procedure.)
- Patient has a life expectancy more than (>) 12 months.
For patients enrolled in a French site:
- Patient is at high risk for surgery as demonstrated by a Logistic EuroSCORE equal or
more than (=) 20 and/or a Society of Thoracic Surgeon (STS) mortality risk score of
more than (>) 10% and/or by clinical judgment of the Heart Team based on the
individual risk profile (comorbidities).
- Not applicable for a patient who has received a Portico Valve as per
participation in an SJM sponsored Regulatory or First-In-Human trial.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Any case in which the Portico Valve would not be indicated for the patient as per
current instructions for use (i.e any "off-label" use).
- Patient has any other aortic valve than tricuspid one.
- Patient has a prosthetic valve or ring in the aortic position.
- Patient needs a concomitant structural heart procedure..
- Patient needs the usage of an embolic protection device.
- Patient is unwilling or unable to comply with all clinical investigation-required
follow-up evaluations.
- Patient is pregnant
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/04/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/10/2022
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Sample size
Target
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Accrual to date
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Final
1032
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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0
St Andrews Hospital - Adelaide
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Recruitment hospital [3]
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0
Heart Care Partners-Wesley Hospital - Auchenflower
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Recruitment hospital [4]
0
0
The Prince Charles Hospital - Chermside
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Recruitment hospital [5]
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0
Royal North Shore hospital - Leonards Hill
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Recruitment hospital [6]
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0
The Alfred Hospital - Melbourne
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Recruitment hospital [7]
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0
Royal Melbourne Hospital - City Campus - Parkville
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Recruitment hospital [8]
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0
Fiona Stanley Hospital - Perth
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Recruitment hospital [9]
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0
North Shore Private Hospital - St Leonards
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Recruitment hospital [10]
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0
Princess Alexandra Hospital - Woolloongabba
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- Parkville
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- Perth
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- St Leonards
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- Woolloongabba
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London
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Morriston
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Funding & Sponsors
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Commercial sector/Industry
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Name
Abbott Medical Devices
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Summary
Brief summary
The purpose of this clinical investigation is to further assess the performance and safety
profile of the commercially-available Portico™ TAVI System in patients with severe
symptomatic aortic stenosis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01802788
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Contacts
Principal investigator
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Lars Søndergaard, DMSc
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Rigshopitalet University Hospital, Copenhagen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01802788
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