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 range

18 Years

Sex

ALL

See this in plain English?

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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