Key result
EDGEFIRM tests M-TEER added to GDMT versus GDMT alone in aFMR and HFpEF.
Why the study?
Randomized trials of M-TEER have largely excluded patients with HFpEF, leaving limited data on its use in atrial functional mitral regurgitation occurring in this cohort.
Does mitral valve transcatheter edge-to-edge repair added to guideline-directed medical therapy improve a composite of cardiovascular mortality, heart failure hospitalization, and KCCQ score in symptomatic patients with atrial functional mitral regurgitation and HFpEF?
RCT
Open-label
2:1
Yes
Does mitral valve transcatheter edge-to-edge repair added to guideline-directed medical therapy improve a composite of cardiovascular mortality, heart failure hospitalization, and KCCQ score in symptomatic patients with atrial functional mitral regurgitation and HFpEF?
The EDGEFIRM trial is designed to evaluate the additive effect of M-TEER compared with GDMT alone in patients with symptomatic atrial functional mitral regurgitation and HFpEF.
BACKGROUND: 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 with preserved ejection fraction (HFpEF). Randomized trials to date have largely excluded patients with HFpEF, leading to limited data in this cohort. METHODS: The randomized evaluation of transcatheter edge-to-edge repair in patients with atrial functional mitral regurgitation and heart failure 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, heart failure hospitalization/worsening heart failure, improvement < 10 points in KCCQ-Score after one year. Secondary endpoints include reduction of mitral regurgitation, device safety, functional capacity as well as the individual components of the combined endpoint. CONCLUSION: The EDGEFIRM trial aims to evaluate the additive effect of M-TEER compared with GDMT only in patients with symptomatic aFMR and HFpEF.
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Öztürk et al. (2026) conducted an RCT in Atrial functional mitral regurgitation (aFMR) and heart failure with preserved ejection fraction (HFpEF). Mitral valve transcatheter edge-to-edge repair (M-TEER) vs. Guideline directed medical therapy (GDMT) only was evaluated on Composite of cardiovascular mortality, heart failure hospitalization/worsening heart failure, and improvement < 10 points in KCCQ-Score after one year. The EDGEFIRM trial is designed to evaluate the additive effect of M-TEER compared with GDMT only on cardiovascular mortality, heart failure events, and KCCQ score in patients with aFMR and HFpEF.
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