Randomized Investigation of the MitraClip Device in Heart Failure: Design and Rationale of the RESHAPE-HF2 Trial Design

作者：Stefan D. Anker, Tim Friede, Ralph Stephan von Bardeleben, Javed Butler, Kaneez Fatima, Monika Diek, Jutta Heinrich, Gerd Hasenfuß, Wolfgang Schillinger, Piotr Ponikowski · 发表于：European Journal of Heart Failure · 年份：2024 · DOI：10.1002/ejhf.3247 · 被引用次数：21 · 研究领域：Cardiac Valve Diseases and Treatments、Heart Failure Treatment and Management、Cardiac pacing and defibrillation studies

AIMS: The safety and effectiveness of the MitraClip device to treat functional mitral regurgitation (FMR) has been tested in previous clinical trials yielding somewhat heterogeneous results in heart failure (HF) patients. Over time, the MitraClip device system has been modified and clinical practice evolved to consider also less severely diseased HF patients with FMR for this therapeutic option. The RESHAPE-HF2 trial aims to assess the safety and effectiveness of the MitraClip device system on top of medical therapy considered optimal in the treatment of clinically significant FMR in symptomatic patients with chronic HF. METHODS: The RESHAPE-HF2 is an investigator-initiated, prospective, randomized, parallel-controlled, multicentre trial designed to evaluate the use of the MitraClip device (used in the most up-to-date version as available at sites) plus optimal standard of care therapy (device group) compared to optimal standard of care therapy alone (control group). Eligible subjects have signs and symptoms of HF (New York Heart Association [NYHA] class II-IV despite optimal therapy), and have moderate-to-severe or severe FMR, as confirmed by a central echocardiography core laboratory; have an ejection fraction between ≥20% and ≤50% (initially 15-35% for NYHA class II patients, and 15-45% for NYHA class III/IV patients); have been adequately treated per applicable standards, and have received appropriate revascularization and cardiac resynchronization therapy, if eligible; h...