Heart failure & cardiomyopathiesTrial design
Study design of the EDGEFIRM trial: transcatheter edge-to-edge repair versus guideline-directed medical therapy in atrial functional mitral regurgitation and HFpEF
- prospective, open-label, randomized, multicentre trial
- 2:1 randomization
- study design
Study context
- Population
- Symptomatic patients under stable guideline-directed medical therapy (GDMT) with significant atrial functional mitral regurgitation (aFMR) (>grade II or grade II with hemodynamic relevance) and HFpEF, considered high risk for surgical therapy by Heart Team evaluation
- Planned comparison
- M-TEER + GDMT vs GDMT only
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Study design of the EDGEFIRM trial: transcatheter edge-to-edge repair versus guideline-directed medical therapy in atrial functional mitral regurgitation and HFpEF. ESC Heart Fail. Published 18 July 2026. doi:10.1093/eschf/xvag203
Summarised from the published abstract; every number is checked against it