Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary… (NCT03271762) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
France330 participantsStarted 2018-03-02
Plain-language summary
The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® in comparison with a surgical treatment strategy in patients with severe primary mitral regurgitation judged eligible for anatomical repair with the MitraClip® or mitral valve surgery with high surgical risk.
This trial is a French and Monegasque, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years ( clinical visit at 1 month, at 6 months and 12 months, phone call at 18 months and clincial visit at 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:
Primary Mitral Regurgitation grade 3+ or 4+
* Patients in class II to IV NYHA
* Mitral valve anatomy appropriate to MitraClip® therapy and mitral valve surgery
* Adult patients judged eligible for mitral valve surgery by the local heart team but at high surgical risk defined as: age ≥ 75 years and STS score ≥ 6 % or one frailty index or one major organ system compromise or one possible procedure-specific impediment (using MVARC definitions) ; or age \< 75 years and STS score \> 8 % or at least one other high-risk criterion following the MVARC definitions; or age \> 80 years and judged at high risk for surgery by the local heart team
* Isolated Mitral valve pathology
* If revascularization procedures are required, they must be performed more than 30 days from intervention (D0)
* Patients affiliate to social security
Non-inclusion Criteria:
* Life expectancy \< 1 year due to non-cardiac conditions
* Secondary Mitral regurgitation
* Evolving endocarditis or active endocarditis or inflammatory disease in the last 3 months
* Patient who cannot tolerate procedural anticoagulation or post procedural antiplatelet regimen
* Rheumatic mitral valve disease
* Evidence of intracardiac, inferior vena cava or femoral venous thrombus
* Valve anatomy not compatible with MitraClip® implantation (cf. colum 3 table 3 page 57)
* Stroke or transient ischaemic event within 30 days before D0
* Modified Rankin Scale ≥4 disability (appendix 9)
* TAVR within 30 days before D0-Un…
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, unplanned hospitalizations for heart failure and mitral valve reintervention