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

Sponsor
Tulane University
Study ID
NCT07254455
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Catheter ablation — PROCEDURE
    A catheter ablation (CA) is a minimally invasive medical procedure for treatment of cardiac arrhythmias. Rhythm control of AF is attempted by pulmonary vein isolation (PVI) and posterior wall isolation (PWI). During the procedure, a catheter is guided to the heart through a blood vessel, which is either the femoral vein or a central vein, in order to ablate abnormal conductive heart tissue that causes the arrhythmias. Ablation is achieved either by thermal (cauterization by radiofrequency (RF) ablation / freezing by cryoballoon) or non-thermal mechanisms (primarily irreversible electroporation (IRE) through pulsed field ablation (PFA)). In case of successful ablation, a normal heart rhythm (sinus rhythm) can be restored.

Study Details

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.

Key Dates

First listed
Nov 28, 2025
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Oct 31, 2031

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard medical therapy for heart failure with preserved ejection fraction arm
    Participants randomized to receive medical treatment will be treated according to locally applicable guidelines for standard of care. The choice of the specific pharmacological treatment will be left to the discretion of the treating physician whether it is a rate or rhythm control based on the clinical picture, but maintenance of sinus rhythm through anti arrhythmic drugs (AADs) in this study arm will be encouraged. Electrical cardioversion using a defibrillator is allowed in this study arm. Medical therapy for HFmrEF/HFpEF will be continued following standard of care.
  • Experimental: Catheter ablation arm
    Participants assigned to CA will undergo the procedure as soon as possible after baseline evaluation (within 5 weeks), following the Heart Rhythm Society (HRS) consensus statement using pulsed field ablation (PFA). The main aim of the procedure is to achieve isolation of all four pulmonary veins (PVs). In participants with paroxysmal AF, only pulmonary vein isolation (PVI) will be performed. In participants with persistent AF, posterior wall isolation (PWI) in addition to PVI will be applied. Medical therapy for HFmrEF/HFpEF will be continued following standard of care. The physician performing the CA must have performed at least 50 prior AF ablation procedures, comprising PVI and PVI +, with the same approach.

Primary Outcome Measure

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) [ Time Frame: Baseline, 12 Months, 36 months ]

Central Contacts

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