- Question
- Does transcatheter mitral-valve repair added to maximal medical therapy improve clinical outcomes in patients with heart failure and secondary mitral regurgitation?
- Design
- Randomized, multicenter, open-label (unmasked) trial enrolling 614 patients at 78 sites in the United States and Canada, with 24 months of follow-up.
- Population
- Patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite maximal doses of guideline-directed medical therapy.
- Intervention
- Transcatheter mitral-valve repair with the MitraClip system plus medical therapy (302 patients).
- Control
- Medical therapy alone (312 patients).
- Primary outcome
- Primary effectiveness end point: all hospitalizations for heart failure within 24 months. Primary safety end point: freedom from device-related complications at 12 months, compared with a prespecified objective performance goal of 88.0%.
- Results
- The annualized rate of heart-failure hospitalization was 35.8% per patient-year in the device group versus 67.9% in the control group (HR 0.53; 95% CI 0.40 to 0.70; P<0.001). All-cause death within 24 months occurred in 29.1% versus 46.1% (HR 0.62; 95% CI 0.46 to 0.82; P<0.001).
- Safety
- Freedom from device-related complications at 12 months was 96.6% (lower 95% confidence limit 94.8%), exceeding the prespecified performance goal (P<0.001).
- Conclusion
- In symptomatic patients with secondary mitral regurgitation despite optimal medical therapy, transcatheter repair lowered heart-failure hospitalizations and all-cause mortality at 24 months compared with medical therapy alone.
- Why it matters
- It was the first randomized trial to show that a mitral-valve intervention improves survival in this population, and it defined the role of percutaneous edge-to-edge repair in carefully selected patients with heart failure.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026