Comparing Catheter Ablation and Medical Treatment for Atrial Fibrillation in Heart Failure Patients A Study on Reducing Hospitalizations, Death, and Improving Quality of Life

What this Trial Is About

Atrial fibrillation AF is a common irregular heart rhythm that contributes to heart failure HF. Researchers are evaluating whether catheter ablation combined with optimal medical therapy can reduce hospitalizations due to heart failure and death compared to medical therapy alone. This international, randomized trial focuses on patients with HF and reduced heart function who have paroxysmal or persistent AF, aiming to clarify if ablation improves survival and quality of life beyond current treatments. Participants will be randomly assigned to either optimal medical therapy following European Society of Cardiology guidelines or to catheter ablation plus optimal medical therapy. The ablation procedure involves pulmonary vein isolation using techniques such as cryoballoon, radiofrequency, or pulsed field ablation, chosen by the treating physician. Additional ablation lesions may be applied as needed. This open-label multicenter trial plans to recruit 1200 patients and is nearly three times larger than previous studies in this area. During the study, participants will be monitored for a minimum of two years, with follow-up extending up to 5.5 years. The main outcome measured is the time to first all-cause death or urgent cardiovascular hospitalization. Secondary outcomes include repeated hospitalizations, quality of life assessed at six and twelve months, and cardiovascular death rates. Researchers will collect electro-anatomical voltage maps during ablation for further analysis, while patients will be regularly assessed for heart function, symptoms, and quality of life through clinical visits and questionnaires.

Cryoballoon/Radiofrequency/Pulsed Field Ablation of Atrial Fibrillation Versus Medical Treatment for Heart