Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Se… (NCT01920698) | Clinical Trial Compass
CompletedNot Applicable
Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation
France304 participantsStarted 2013-11
Plain-language summary
The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous MitraClip procedure and optimal standard of care therapy) in patients with severe secondary mitral regurgitation.
This trial is a French, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months and 24 months).
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.
Inclusion Criteria:
* Age \> 18 years old
* Severe secondary mitral regurgitation characterised, according to the European guidelines and recommendations, by a regurgitant volume\>30 mL/beat or an effective regurgitant orifice\>20 mm².
* New York heart Association Class≥ II.
* Left ventricular ejection fraction between 15% and 40%
* Minimum of 1 hospitalization for heart failure within 12 months preceding randomization
* Optimal standard of care therapy for heart failure according to investigator.
* Not eligible for a mitral surgery intervention according to the Heart Team.
* Willingness to participate in the study and signed written informed consent
* Affiliation to a health insurance system or a similar system
Exclusion Criteria:
* Eligible for a mitral surgery intervention according to the Heart Team.
* Primary mitral regurgitation.
* Myocardial infarction or coronary bypass grafting surgery within three months prior to randomization.
* Cardiac resynchronization therapy within three months prior to randomization.
* Cardioversion within three months prior to randomization
* Transcatheter aortic valve implantation within three months prior to randomization
* Need for any cardiovascular surgery (including registration on cardiac transplant list).
* Coronary angioplasty within one month prior to randomization.
* Previous surgical mitral valve repair.
* Renal replacement therapy.
* Active infection requiring current antibiotic therapy.
* Severe hepatic insufficiency.
* Strok…
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
1
All-cause mortality and unplanned hospitalizations for heart failure