Home › Trials › NCT03271762

Endovascular treatment for severe mitral regurgitation using MitraClip

Multicentre and Randomized Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery

Not applicable Interventional Nantes University Hospital · NCT03271762

This study is testing whether the MitraClip treatment can help people with severe mitral regurgitation who can't have surgery feel better compared to traditional surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment330 (estimated)
Ages18 Years and up
SexAll
SponsorNantes University Hospital Academic / other
Locations34 sites (Angers and 33 other locations)
Trial IDNCT03271762 on ClinicalTrials.gov

What this trial studies

This multicenter trial aims to compare the clinical efficacy of the MitraClip® endovascular treatment strategy against traditional surgical treatment in patients with severe primary mitral regurgitation who are deemed high-risk for surgery. Participants will be followed for two years, with clinical visits and phone check-ins to monitor their health outcomes. The study focuses on patients with significant mitral valve issues who are not ideal candidates for surgery due to various health risks. The goal is to establish the non-inferiority of the MitraClip® approach in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults with severe primary mitral regurgitation who are at high surgical risk and have appropriate mitral valve anatomy.

Not a fit: Patients with secondary mitral regurgitation or those with a life expectancy of less than one year due to non-cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive option for high-risk patients suffering from severe mitral regurgitation.

How similar studies have performed: Previous studies have shown promising results with the MitraClip® approach, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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-Untreated, clinically significant coronary artery disease requiring revascularization
* Any percutaneous cardiovascular intervention within 30 days before D0 including ATC
* Cardiovascular surgery, or carotid surgery within 30 days before D0
* Any prior mitral valve surgery or transcatheter mitral valve procedure
* Need for any concomitant cardiac surgery including treatment of severe secondary tricuspid regurgitation in accordance with class I recommendation in 2017 ESC guidelines. Surgical treatment of mild or moderate secondary tricuspid regurgitation (Class IIa and IIb recommendations) can still be performed in the protocol according to the local heart team decison
* NYHA functional class I
* LVEF \< 30%
* Primary MR grade 1 to 2
* Subjects in whom transesophageal echocardiography or transseptal catheterization are contraindicated or high-risk
* Any condition preventing the patient from completing all protocol procedures (including compliance with guidelines directed medical therapy) and follow-up visits
* Patient unable or unwilling to provide written, informed consent before study enrolment
* Pregnant or nursing women
* Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship
* Participation in another trial that would interfere with this trial

Exclusion criteria

* Not eligible for a MitraClip® intervention after Core Lab evaluation
* Before randomization (D-21) the patient no longer fulfills eligibility criteria (inclusion criteria and non-inclusion criteria)

Where this trial is running

Angers and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mitral RegurgitationMITRACLIPprimary Mitral Regurgitationhigh surgical risks
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.