Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation (NCT07414225) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation
China400 participantsStarted 2026-02-25
Plain-language summary
This study is a prospective, randomized, parallel-control, open-label, multicenter clinical trial. Eligible subjects will be randomized in a 1:1 ratio to the Device group (Interventional group) or to no Device group (Control Group). The objective is to identify the safety and effectiveness of the TEER for the treatment of moderate-to-severe (3+) or severe (4+) atrial functional mitral regurgitation (aFMR) in patients who are symptomatic despite maximally tolerated guideline directed medical therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 years or older
✓. Echocardiographic core laboratory criteria (all must be present):
✓. Atrial FMR (FMR must be atrial in etiology without ventricular leaflet tethering)
✓. Severe MR (3+ or 4+) defined as either 1) an effective regurgitant orifice area (EROA) ≥0.3 cm² or pulmonary-venous systolic flow reversal (PSVFR), or 2) in the absence of PSVFR, EROA measures 0.20-0.29 cm² with one or more of the following: regurgitant volume ≥45 mL/beat, regurgitant fraction ≥40%, or vena contracta width ≥0.5 cm.
✓. LV ejection fraction ≥50% without more than mild regional wall motion abnormalities
✓. No or mild LV dilatation (LV end-diastolic volume index \<79 mL/m2 \[male\] or \<71 mL/m² \[female\])
✓. Left atrial dilation (left atrial volume index ≥34 mL/m²)
✓. Mitral annulus dilatation (AP diameter \>35mm)
Exclusion criteria
✕. Patient is clinically unstable or has been hospitalized within the prior 30 days.
✕. Primary degenerative or organic mitral valve disease such as prolapse, Barlow's disease, rheumatic heart valve disease causing leaflet thickening, leaflet clefts or perforation, endocarditis, etc. Note: A small amount of mitral leaflet thickening or other abnormality may be present, but it cannot be the primary cause of MR.
✕. Moderate or severe mitral annular calcification, or any degree of mitral annular calcification if it is the primary cause of the MR or would interfere with TEER.
What they're measuring
1
Time to first occurrence of a composite event of death from any cause, hospitalization for [worsening] heart failure or unplanned outpatient [worsening] heart failure event within 24 months
Timeframe: From enrollment to the end of treatment at 24 months
2
Number of participants with the primary safety endpoint (device group only)
Timeframe: From enrollment to the end of treatment at 30 days
✕. Mitral valve area (MVA) \<4.0 cm² or mean trans-mitral valve gradient \>4 mmHg.
✕. Intent to treat the patient with mitral valve surgery within the next 24 months if randomized to control
✕. Known cardiomyopathy such as amyloid, sarcoid or hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or pericardial diseases such as constrictive pericarditis.
✕. Previous mitral valve surgery or transcatheter mitral valve intervention.
✕. Any severe valvular disease of the pulmonary valve or tricuspid valve, or moderate or severe disease of the aortic valve.