The clinical equipoise in the treatment of Atrial Fibrillation (AF) in patients with Heart Failure with mildly reduced Ejection Fraction/Heart Failure with Preserved Ejection Fraction (HFmrEF/HFpEF) reflects the scarcity of randomized trials on different treatment modalities. By generating high-quality, evidence-based, randomized data on the impact of treatment on hard outcomes, Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients with Heart Failure with Preserved Ejection Fraction (CASTLE-HFpEF) will provide clinical decision-making guidance and help physicians in the management of patients with HFmrEF/HFpEF and AF.
The main hypothesis is that Catheter Ablation (CA) for AF is associated with improved clinical outcomes in patients with HFmrEF/HFpEF and AF compared to medical AF treatment strategies on top of optimal medical HF treatment. CASTLE-HFpEF aims to study these hard clinical outcomes in a randomized cohort of patients with AF and HFmrEF/HFpEF.
≥18 years of age at screening visit.
Clinical signs and symptoms of HF (26).
Left ventricular ejection fraction (LVEF) >40% within the past 12 months (most recent LVEF measurement)
For patients in normal sinus rhythm (NSR) at the time of blood sampling: NT proBNP ≥300 pg/mL
Previous catheter ablation for AF.
Known infiltrative cardiomyopathy, hypertrophic cardiomyopathy and amyloidosis.
Documented left atrial diameter >6cm.
Any contraindication for chronic anticoagulation therapy or heparin, including hypersensitivity to any of the components.
Tulane University
Lead sponsor
Boston Scientific Corporation
Collaborator
Johnson & Johnson
Collaborator