Comparing Radiofrequency Catheter Ablation and Medication for Atrial Fibrillation in Patients with Heart Failure with Preserved Ejection Fraction STABLE-SR IV Trial

What this Trial Is About

Researchers are evaluating whether radiofrequency catheter ablation RFCA is better than antiarrhythmic drugs AADs for patients who have atrial fibrillation AF and heart failure with preserved ejection fraction HFpEF. This study focuses on patients already receiving optimized anti-heart-failure drug therapy and aims to compare their long-term clinical outcomes. The trial is international, prospective, multi-center, and randomized, designed to provide clear evidence in this patient group. Participants will be randomly assigned to one of two groups one group will receive RFCA, a procedure involving a specialized catheter to isolate pulmonary veins and modify heart tissue to control AF, while the other group will receive medical therapy with AADs like amiodarone or dronedarone, following current guidelines including rhythm or rate control. Before randomization, participants undergo a 5-week run-in period where heart failure treatments and anticoagulation are optimized. The follow-up period lasts up to 2 to 3 years after enrollment. During the study, participants will have physical exams, echocardiograms, blood tests including NT-proBNP levels, and quality of life assessments at various times. Researchers will monitor hospitalizations due to worsening heart failure, urgent visits, cardiovascular death, and changes in heart function and symptoms. The main outcome is the time to first event of worsening heart failure or cardiovascular death. The study also tracks walking ability, heart rhythm, and medication changes over time to evaluate overall health and treatment impact.

Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)