Heart failure & cardiomyopathies

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 FailPublished prospective, open-label, randomized, multicentre trial

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
Methodological details2:1 randomization, study design
  • 2:1 randomization
  • Study design

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

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