Study Comparing Medication vs. Conduction System Pacing and AV Node Ablation for Treating Chronic Atrial Fibrillation with Heart Failure

What this Trial Is About

Atrial fibrillation AF is an irregular heartbeat that can cause symptoms such as skipped beats, shortness of breath, stroke, or fluid buildup in the lungs or legs. The study evaluates different treatment approaches for AF, focusing on controlling the heart rate. It compares a new pacemaker technique called Conduction System Pacing CSP combined with atrioventricular AV node ablation against optimal medical therapy to see which is more effective for patients with chronic AF and heart failure symptoms. Participants are randomly assigned to one of two groups. One group receives guideline-directed medical therapy for heart failure and rate control medications, with an implantable cardioverter defibrillator ICD if their hearts left ventricular ejection fraction LVEF is 35% or lower. The other group receives CSP and ICD implantation within 10 working days, followed by catheter AV node ablation within four weeks. The study uses a parallel design to compare these treatments over time. Throughout the study, participants undergo evaluations measuring outcomes such as survival rates, heart failure events, hospitalizations, quality of life, exercise capacity, biochemical markers, and cognitive function over periods of six to twelve months. Researchers monitor the participants progress to assess the effectiveness and safety of the treatments. The total study duration extends up to the end of 2029, with primary outcome data collected after 12 months.

RAFT - Pace &Ablate