A randomised controlled study of atrial fibrillation ablation vs medical therapy in patients with persistent atrial fibrillation and heart failure with preserved ejection fraction: RCT STALL-HFpEF

This is a multi centre randomized controlled trial examining a strategy of rhythm control using AF ablation versus optimal medical therapy in patients with co-morbid paroxysmal or persistent AF and heart failure with preserved ejection fraction (AF-HFPEF). Procedures: Standard / Routine pulmonary vein isolation will be performed in patients undergoing ablation. The standard procedure involves a minimally invasive procedure in which the patient is taken to the cardiac catheter laboratory. The procedure is performed under general anaesthesia. Once femoral venous access is obtained, catheters are advanced into the heart. The pulmonary veins in the left atrium are targeted with radio frequency ablation using special catheters that can deliver radiofrequency energy to the atrial tissue. At the end of the procedure, all sheaths and catheters are removed from body. Care provided by Cardiologist and Electrophysiologists with minimum 5 years procedural experience who will be looking after the patients regardless of whether they are part of the trial a) what the Intervention involves: Atrial fibrillation / pulmonary vein isolation (PVI) ablation. Compares invasive ablative management of atrial fibrillation vs optimal medical therapy. Involve comparing surgical intervention vs medical therapy alone. PVI is commonly performed for patients with atrial fibrillation. b) Frequency / duration of intervention: Atrial fibrillation ablation is performed once initially. If necessary repeat procedure is offered if there is a recurrence as part of standard care. Follow up in clinic once every three months for a 20 minute consultation for 6 months as per usual care. c) Mode of administration: In person. During surgery or face to face interaction during follow up. d) Procedure is performed by experienced operators at participating sites who perform these procedures as part of their usual practice with at least 5 years experience. e) Procedure and follow up will be performed at participating sites as per usual practice. f) Target intensity – Not applicable g) Adherence – Not applicable h) Follow up period: 6 months i) Titration: There is no titration in patients undergoing AF ablation. Strategy of ablation will be fixed in all patients undergoing AF ablation. The ablation may be individualised based on intraoperative findings such as need for additional ablation.