AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System (NCT03339115) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
Germany30 participantsStarted 2018-04-23
Plain-language summary
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation. Data collected in this clinical study will include 30-day safety and performance, and long-term clinical outcomes over a follow-up of 2 years.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Age ā„ 18 years
ā. NYHA functional II, III or ambulatory IV
ā. Severe mitral regurgitation (MR grade 3-4+)
ā. Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated.
ā. Elevated risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum) based on STS/Euro Score II (per MVARC Part 1), frailty and co-morbidities.
ā. Able to undergo Transesophageal Echocardiography (TEE).
ā. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
ā. The subject commits to return for the scheduled post-operative follow-up visits at the hospital.
Exclusion criteria
ā. Prior stroke or TIA within 3 months or Modified Rankin Scale ā„4 disability
ā. Acute myocardial infarction within the previous 30 days
ā. Any prior heart valve surgery or transcatheter mitral intervention
ā. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
What they're measuring
1
The primary safety endpoint is freedom from all-cause mortality and major adverse events
ā. Rheumatic heart disease or endocarditis within the previous 3 months
ā. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
ā. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)