CASTLE-HFpEF (Catheter Ablation for Atrial Fibrillation Patients With Heart Failure With Mildly R… (NCT07254455) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
CASTLE-HFpEF (Catheter Ablation for Atrial Fibrillation Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction)
900 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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Inclusion criteria
✓. ≥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)
✓. Elevated NT-proBNP levels during screening or within 12 months prior to screening (most recent value; blood test):
✓. Echocardiographic evidence of HFmrEF/HFpEF, with at least one of the following during screening or within the 12 months prior to screening:
✓. Left atrial volume index (LAVI) ≥34 mL/m2 for patients in NSR, or LAVI ≥40 mL/m2 for patients in AF.
✕. Known infiltrative cardiomyopathy, hypertrophic cardiomyopathy and amyloidosis.
What they're measuring
1
Composite endpoint of all-cause mortality, stroke or transient ischemic attack (TIA), and hospitalizations for worsening HF and clinically relevant decrease of NT proBNP (after 12 months)