- Question
- Does transcatheter mitral-valve repair, added to guideline-recommended medical therapy, improve outcomes in patients with heart failure and moderate to severe functional mitral regurgitation?
- Design
- Randomized, controlled trial, 1:1, enrolling 505 patients at 30 sites in nine countries. The registry lists single masking.
- Population
- Patients with heart failure and moderate to severe functional mitral regurgitation who were receiving medical therapy.
- Intervention
- Transcatheter mitral-valve repair with the MitraClip device plus guideline-recommended medical therapy (250 patients).
- Control
- Guideline-recommended optimal medical therapy alone (255 patients).
- Primary outcome
- Three primary end points: rate of first or recurrent heart failure hospitalization or cardiovascular death over 24 months; rate of first or recurrent heart failure hospitalization over 24 months; and change in KCCQ-OS score from baseline to 12 months.
- Results
- The rate of heart failure hospitalization or cardiovascular death was 37.0 per 100 patient-years with the device and 58.9 with control (rate ratio 0.64; 95% CI 0.48 to 0.85; P = 0.002). Heart failure hospitalizations were 26.9 vs 46.6 per 100 patient-years (rate ratio 0.59; 95% CI 0.42 to 0.82; P = 0.002). The KCCQ-OS improved by 10.9 more points with the device (95% CI 6.8 to 15.0; P<0.001).
- Safety
- Device-specific safety events occurred in 4 patients (1.6%).
- Conclusion
- Adding transcatheter mitral-valve repair to medical therapy reduced heart failure hospitalizations and cardiovascular death and improved health status compared with medical therapy alone.
- Why it matters
- Supports transcatheter mitral-valve repair as an adjunct to medical therapy in selected patients with heart failure and significant functional mitral regurgitation.
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 14, 2026