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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/NCT03022461
Registration number
NCT03022461
Ethics application status
Date submitted
12/01/2017
Date registered
16/01/2017
Date last updated
27/06/2022
Titles & IDs
Public title
HeartMate 3 CE Mark Study Long Term Follow-up
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Scientific title
HeartMate 3 CE Mark Study Long Term Follow-up Clinical Investigation Plan
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Secondary ID [1]
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HeartMate 3 CE Mark Study LTFU
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Universal Trial Number (UTN)
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Trial acronym
HM3 CE LTFU
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Refractory Left Ventricular Heart Failure
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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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
Other interventions - Long term follow-up
Ongoing HM3 CE Mark study patients - The study will include the ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection.
Other interventions: Long term follow-up
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Intervention code [1]
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Other interventions
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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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Survival
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Assessment method [1]
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Subject outcomes and survival over time
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Timepoint [1]
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At 5 years post HM3 CE Mark study implant
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Secondary outcome [1]
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EuroQoL 5D-5L (EQ-5D-5L) VAS Score
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Assessment method [1]
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Quality of Life over time as measured by EuroQoL 5D-5L (EQ-5D-5L) VAS Score. The Visual Analog Scale (VAS) records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life
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Timepoint [1]
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At 5 years post HM3 CE Mark study implant
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Secondary outcome [2]
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Six Minute Walk Test (6MWT)
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Assessment method [2]
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Functional status over time as measured by the Six Minute Walk Test (6MWT). The 6MWT is done to establish the amount of meters a subject can walk in 6 minutes
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Timepoint [2]
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At 5 years post HM3 CE Mark study implant
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Secondary outcome [3]
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New York Heart Association (NYHA)
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Assessment method [3]
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Functional status over time as measured by New York Heart Association (NYHA). Patients are graded from 4 to 1 in order or symptoms:
I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
IIIA Marked limitation of physical activity. No dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
IIIB Marked limitation of physical activity. Recent dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
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Timepoint [3]
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At 5 years post HM3 CE Mark study implant
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Secondary outcome [4]
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Adverse Events
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Assessment method [4]
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Number of Participants with Adverse Events
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Timepoint [4]
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Between 2 and 5 years post HM3 CE Mark study implant
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Secondary outcome [5]
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Device Malfunctions
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Assessment method [5]
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Number of Participants with device malfunctions
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Timepoint [5]
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Between 2 and 5 years post HM3 CE Mark study implant
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Secondary outcome [6]
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Reoperations
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Assessment method [6]
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Number of reoperations
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Timepoint [6]
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Between 2 and 5 years post HM3 CE Mark study implant
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Secondary outcome [7]
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Rehospitalizations
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Assessment method [7]
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Number of rehospitalizations
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Timepoint [7]
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Between 2 and 5 years post HM3 CE Mark study implant
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Secondary outcome [8]
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Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3)
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Assessment method [8]
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Modified Rankin Score >3 is considered debilitating. As in 3 cases the MRS evaluation was not available, a sensitivity analysis for the worst and best case scenario was performed.
The MRS scale is as following:
0: No observed neurological symptoms; 1: No significant neurological disability despite symptoms; able to carry out all usual duties and activities; 2: Slight neurological disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3: Moderate neurological disability; requiring some help, but able to walk without assistance; 4: Moderate severe neurological disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe neurological disability; bedridden, incontinent and requiring constant nursing care and attention as a result of a neurological deficit; 6: Dead
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Timepoint [8]
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As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first
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Eligibility
Key inclusion criteria
1. Patient or legal representative has signed Informed Consent Form (ICF).
2. Patient was enrolled in the HeartMate 3 CE Mark Study and continues to be supported
with the HeartMate 3 LVAS after the 2 year CE Mark study follow-up.
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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
1. Patient does not consent to the continued data collection.
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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
23/06/2014
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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
12/12/2019
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Sample size
Target
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Accrual to date
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Final
25
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Vienna
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Country [2]
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Canada
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State/province [2]
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Ontario
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Country [3]
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Czechia
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State/province [3]
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Prague
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Country [4]
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Germany
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State/province [4]
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Berlin
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Country [5]
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Germany
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State/province [5]
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Freiburg
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Country [6]
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Germany
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State/province [6]
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Hannover
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Country [7]
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Kazakhstan
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State/province [7]
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Astana
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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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 clinical investigation is to report the long term survival and incidence
of adverse events in the patients who were implanted with HM3 in the CE Mark Study and
continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up.
The study will be a single arm, prospective, multi-center, non-blinded and non-randomized
study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that
completed the 2-year follow-up in the HeartMate 3 CE Mark study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03022461
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Carlo Gazzola, B. Sc.
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Address
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Abbott
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03022461
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