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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03170349
Registration number
NCT03170349
Ethics application status
Date submitted
26/05/2017
Date registered
31/05/2017
Titles & IDs
Public title
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
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Scientific title
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
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Secondary ID [1]
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2016-05
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Universal Trial Number (UTN)
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Trial acronym
CLASP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mitral Valve Regurgitation
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Mitral Valve Repair
Experimental: Edwards PASCAL Transcatheter Mitral Valve Repair System -
Treatment: Devices: Mitral Valve Repair
Minimal Invasive Transcatheter Mitral Valve Repair
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Intervention code [1]
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Treatment: Devices
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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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Number of Participants With Major Adverse Events (MAE)
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Assessment method [1]
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Composite of major adverse events (MAE) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 30 days
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Timepoint [1]
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30 days
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Primary outcome [2]
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Device Success
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Assessment method [2]
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Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.
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Timepoint [2]
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Exit from the cardiac catheterization laboratory
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Primary outcome [3]
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Number of Participants With Procedural Success
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Assessment method [3]
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Device success with evidence of mitral regurgitation reduction = MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge. Mitral regurgitation was assessed per independent echocardiography core laboratory.
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Timepoint [3]
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through discharge
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Primary outcome [4]
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Clinical Success
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Assessment method [4]
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Procedural success with evidence of MR reduction = MR2+ and without MAEs at 30 days. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.
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Timepoint [4]
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30 days
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Secondary outcome [1]
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Mitral Regurgitation Reduction
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Assessment method [1]
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Mitral regurgitation reduction at 30 days, 6 months, 1 year and annually thereafter over baseline. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.
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Timepoint [1]
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baseline, 30 days, 6 months, 1 year, 2 year
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Secondary outcome [2]
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All-cause Mortality
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Assessment method [2]
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All-cause mortality at 30 days, 6 months, 1 year and annually thereafter
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Timepoint [2]
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30 days, 6 months, 1 year, 2 year
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Secondary outcome [3]
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Recurrent Heart Failure Hospitalization
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Assessment method [3]
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Recurrent heart failure hospitalization at 30 days, 6 months, 1 year and annually thereafter
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Timepoint [3]
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30 days , 6 months, 1 year, 2 year
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Secondary outcome [4]
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Re-intervention Rates for Mitral Regurgitation
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Assessment method [4]
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Re-intervention rates for mitral regurgitation at 30 days, 6 months, 1 year and annually thereafter
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Timepoint [4]
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30 days, 6 months, 1 year, 2 year
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Secondary outcome [5]
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Composite of Major Adverse Events (MAE) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Re-intervention for Study Device Related Complications
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Assessment method [5]
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Composite of major adverse events (MAE) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 6 months, 1 year and annually thereafter
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Timepoint [5]
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6 months, 1 year, 2 year
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Secondary outcome [6]
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Change in Left Ventricular End Diastolic Volume (LVEDV)
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Assessment method [6]
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Change in Left Ventricular End Diastolic Volume (LVEDV) at 6 months, and 1 year over baseline
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Timepoint [6]
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6 months, 1 year, 2 year
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Secondary outcome [7]
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Change in Left Ventricular End Systolic Volume (LVESV)
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Assessment method [7]
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Change in Left Ventricular End Systolic Volume (LVESV) at 6 months and 1 year over baseline
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Timepoint [7]
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6 months, 1 year, 2 year
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Secondary outcome [8]
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Change in Pulmonary Artery Systolic Pressure
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Assessment method [8]
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Change in Pulmonary Artery Systolic Pressure at 6 months, and 1 year over baseline
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Timepoint [8]
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baseline, 6 months, 1 year
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Secondary outcome [9]
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Change in Six Minute Walk Test (6MWT) Distance
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Assessment method [9]
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Mean distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months, and 1 year compared to baseline
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Timepoint [9]
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6 months, 1 year
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Secondary outcome [10]
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Change in Quality of Life (QoL) Score, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
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Assessment method [10]
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Mean KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.
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Timepoint [10]
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baseline, 30 days, 6 months, 1 year
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Secondary outcome [11]
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Change in Quality of Life (QoL) Score, as Measured by EQ5D
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Assessment method [11]
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Change in Quality of Life (QoL) score, as measured by EQ5D at 30 days, 6 months over baseline. The EQ5D self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher health-related quality of life.
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Timepoint [11]
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baseline, 30 days, 6 months, 1 year
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Secondary outcome [12]
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Change in NYHA Functional Classification
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Assessment method [12]
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Change in NYHA Functional Classification at 6 months and 1 year over baseline. NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.
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Timepoint [12]
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baseline, 6 months, 1 year, 2 year
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Secondary outcome [13]
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Change NT-pro-BNP Level
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Assessment method [13]
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Change in NT-pro-BNP level at 6 months and 1 year and annually thereafter over baseline
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Timepoint [13]
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baseline, 6 months, 1 year, 2 year
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Secondary outcome [14]
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Change in BNP Level
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Assessment method [14]
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Change in BNP level at 6 months, 1 year and annually thereafter over baseline
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Timepoint [14]
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baseline, 6 months, 1 year, 2 year
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Secondary outcome [15]
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Change in Tricuspid Regurgitation (TR) at 6 Months, 1 Year and Annually Thereafter Over Baseline
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Assessment method [15]
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Change in TR over baseline at 6 months, and 1 year. TR grade was assessed by an independent echocardiography core lab using a 6-grade scale: None, trace, mild, mild-moderate, moderate-severe, or severe. Reduction by 1 or more grades reflects improvement from baseline, while an increase by 1 or more grades reflects worsening of TR.
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Timepoint [15]
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6 months, 1 year, 2 year
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Secondary outcome [16]
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Change in Effective Regurgitant Orifice Area (EROA)
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Assessment method [16]
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Change in effective regurgitant orifice area (EROA) at 30 days, 6 months, 1 year and annually thereafter over baseline.
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Timepoint [16]
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baseline, 30 days, 6 months, 1 year, 2 year
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Secondary outcome [17]
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Change in Mitral Regurgitant Volume
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Assessment method [17]
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Change in mitral regurgitant volume at 30 days, 6 months, 1 year and annually thereafter over baseline
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Timepoint [17]
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baseline, 30 days, 6 months, 1 year, 2 year
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Eligibility
Key inclusion criteria
* Signed and dated IRB/ethics committee approved study consent form prior to study related procedures
* Eighteen (18) years of age or older
* New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy
* Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation
* Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
* The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant.
* Mitral valve area (MVA) = 4.0 cm² as measured by planimetry. If MVA by planimetry is not measurable, pressure half-time measurement is acceptable.
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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
* Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
* Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation.
* Mitral valve area (MVA) < 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable)
* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
* Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction
* Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
* Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment
* Patient is under guardianship
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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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
27/06/2017
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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
31/08/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
124
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Recruitment in Australia
Recruitment state(s)
ChermsideNSW
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Recruitment hospital [1]
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Metro North Hospital & Health Service, The Prince Charles Hospital - Brisbane
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Recruitment hospital [2]
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Sydney Local Health District, Royal Prince Alfred Hospital - Camperdown
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Recruitment postcode(s) [1]
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QLD 4032 - Brisbane
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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Michigan
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Country [5]
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United States of America
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State/province [5]
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New Jersey
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Country [6]
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United States of America
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State/province [6]
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North Carolina
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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United States of America
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State/province [8]
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Virginia
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Country [9]
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Canada
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State/province [9]
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British Columbia
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Country [10]
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Canada
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State/province [10]
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Ontario
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Country [11]
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Germany
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State/province [11]
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Bonn
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Country [12]
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Greece
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State/province [12]
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Athens
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Country [13]
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Italy
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State/province [13]
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Milano
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Country [14]
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Switzerland
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State/province [14]
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Bern
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Edwards Lifesciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
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Trial website
https://clinicaltrials.gov/study/NCT03170349
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Trial related presentations / publications
Webb JG, Hensey M, Szerlip M, Schafer U, Cohen GN, Kar S, Makkar R, Kipperman RM, Spargias K, O'Neill WW, Ng MKC, Fam NP, Rinaldi MJ, Smith RL, Walters DL, Raffel CO, Levisay J, Latib A, Montorfano M, Marcoff L, Shrivastava M, Boone R, Gilmore S, Feldman TE, Lim DS. 1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study. JACC Cardiovasc Interv. 2020 Oct 26;13(20):2344-2357. doi: 10.1016/j.jcin.2020.06.019. Lim DS, Kar S, Spargias K, Kipperman RM, O'Neill WW, Ng MKC, Fam NP, Walters DL, Webb JG, Smith RL, Rinaldi MJ, Latib A, Cohen GN, Schafer U, Marcoff L, Vandrangi P, Verta P, Feldman TE. Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. JACC Cardiovasc Interv. 2019 Jul 22;12(14):1369-1378. doi: 10.1016/j.jcin.2019.04.034. Epub 2019 Jun 26.
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Public notes
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Contacts
Principal investigator
Name
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Gideon Cohen, MD
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Address
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Sunnybrook Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/49/NCT03170349/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/49/NCT03170349/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03170349