Clinical Trial

CASTLE-HFpEF (Catheter Ablation for Atrial Fibrillation Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction)

Not Yet Recruiting
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Summary
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.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2028-06 -> 2027-12 2026-06-16
minor Completion pushed: 2030-10 -> 2031-10 2026-06-16
Trial Details
NCT Number NCT07254455
Lead Sponsor Tulane University
Collaborators: Boston Scientific Corporation, Johnson & Johnson
Conditions Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction
Enrollment 900 participants
Start Date 2026-07
Primary Completion 2027-12 (estimated)
Study Completion 2031-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-15