WithdrawnNot Applicable

Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System

Stopped: Amended and merged with AHEAD-EU study

Greece, Poland0Started 2019-09

Plain-language summary

The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. the procedure is performed under general anesthesia.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
✕. Acute myocardial infarction within the previous 30 days
✕. Any prior heart valve surgery or transcatheter mitral intervention
✕. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
✕. Rheumatic heart disease or endocarditis within the previous 3 months
✕. 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
✕. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
✕. Untreated clinically signiﬁcant coronary artery disease requiring revascularization

What they're measuring

Freedom from major device- or procedure- related serious adverse events

Timeframe: 30 days

Trial details

NCT IDNCT03714412

SponsorCardiovalve Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-15

View on ClinicalTrials.gov More Mitral Regurgitation trials