Study of Catheter Ablation vs Medication for Severe Mitral Valve Leakage and Persistent Atrial Fibrillation

What this Trial Is About

This trial investigates treatments for patients with persistent atrial fibrillation AF combined with severe atrial functional mitral regurgitation MR, a condition where AF worsens mitral valve leakage and heart function. The study aims to compare catheter ablation plus medication versus medication alone to see which better reduces MR severity and improves patient outcomes. It is designed as a randomized controlled trial enrolling 146 patients at multiple sites in China. Participants will be randomly assigned to either receive catheter ablation combined with guideline-directed medical therapy, anticoagulation, and rate control medications or to receive medical therapy alone. The trial includes an initial 3-month follow-up assessing MR severity via echocardiography, with secondary outcomes including mortality, hospitalizations, quality of life, and heart rhythm measures. After this, an extension study ELEVATE-AF X will continue for up to 12 months to evaluate long-term outcomes and allow further ablation if needed. During the study, participants will undergo transthoracic echocardiography, clinical assessments, questionnaires on quality of life, and monitoring for any arrhythmia episodes. Researchers will track safety outcomes such as surgical complications, bleeding, stroke, and systemic embolism. The study carefully measures changes in MR severity, heart function, and patient well-being over time, with active follow-up visits through the first year.

Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial