- Question
- In patients with heart failure and secondary mitral regurgitation, is transcatheter edge-to-edge repair noninferior to mitral-valve surgery?
- Design
- Multicenter, randomized 1:1, open-label (no masking) noninferiority trial conducted in Germany, with 210 patients randomized.
- Population
- Patients with heart failure and secondary mitral regurgitation who remained symptomatic despite guideline-directed medical therapy. Mean age was 70.5 years, 39.9% were women, and mean left ventricular ejection fraction was 43.0%.
- Intervention
- Transcatheter edge-to-edge mitral-valve repair (MitraClip system, Abbott).
- Control
- Mitral-valve surgery, either repair or replacement, with technique and access at the discretion of the participating surgical center.
- Primary outcome
- Composite of death, hospitalization for heart failure, mitral-valve reintervention, assist-device implantation, or stroke within 1 year after the procedure. The primary safety end point was a composite of major adverse events within 30 days.
- Results
- The primary efficacy end point occurred in 16 of 96 patients (16.7%) with available data in the intervention group and 20 of 89 (22.5%) in the surgery group (estimated mean difference, -6 percentage points; 95% CI, -17 to 6; P<0.001 for noninferiority). Thirty-day safety events occurred in 15 of 101 patients (14.9%) with TEER and 51 of 93 (54.8%) with surgery.
- Safety
- Major adverse events at 30 days were markedly less frequent with transcatheter repair (estimated mean difference, -40 percentage points; 95% CI, -51 to -27; P<0.001).
- Conclusion
- Transcatheter edge-to-edge repair was noninferior to mitral surgery for the 1-year clinical composite and was associated with fewer early adverse events.
- Why it matters
- It provided the first randomized evidence comparing both strategies in secondary mitral regurgitation, supporting transcatheter repair as a valid alternative to surgery in 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 18, 2026