Study design of the EDGEFIRM trial: transcatheter edge-to-edge repair versus guideline-directed medical therapy in atrial functional mitral regurgitation and HFpEF.

INTRODUCTION: Over the past decade, mitral valve transcatheter edge-to-edge repair (M-TEER) has become an established interventional treatment option for functional mitral regurgitation. One subtype that has recently gained increasing scientific attention is atrial functional mitral regurgitation (aFMR) occurring in patients with heart failure (HF) with preserved ejection fraction (HFpEF). Randomized trials to date have largely excluded patients with HFpEF, leading to limited data in this cohort.

STUDY DESIGN: The randomized evaluation of transcatheter edge-to-edge repair in patients with atrial functional mitral regurgitation and HF with preserved ejection fraction compared with GDMT (EDGEFIRM) is a prospective, open-label, randomized, multicentre trial evaluating the additive effect of M-TEER in patients with aFMR and HFpEF compared to guideline-directed medical therapy (GDMT) only. Eligible patients must be symptomatic under stable GDMT with significant aFMR (>grade II or grade II with hemodynamic relevance) and HFpEF and considered high risk for surgical therapy by Heart Team evaluation. Randomization will be conducted in a 2:1 manner M-TEER + GDMT vs GDMT only. The primary combined endpoint consists of cardiovascular mortality, HF hospitalization/worsening HF, improvement <10 points in KCCQ-Score after 1 year. Secondary endpoints include reduction of mitral regurgitation, device safety, functional capacity as well as the individual components of the combined endpoint.

DISCUSSION: The EDGEFIRM trial aims to evaluate the additive effect of M-TEER compared with GDMT only in patients with symptomatic aFMR and HFpEF.

© The Author(s) 2026. Published by Oxford University Press on behalf of the European Society of Cardiology.

PMID: 42503500