NCT07181291

Pulsed Field or Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation in Heart Failure

Pulsed Field or Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation in Heart Failure (a Propensity Score Matched Comparison)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 700 (actual)
• Sponsor: St. Josefs-Hospital Wiesbaden GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Patients with atrial fibrillation (AF) and heart failure with reduced left ventricular ejection fraction (HFrEF) are at particularly high cardiovascular risk. Rhythm-control by means of catheter-based pulmonary vein isolation (PVI) reduces all-cause mortality and rehospitalization for worsening heart failure in these patients. Considering the globally increasing use of the novel "pulsed-field ablation", it is necessary to determine whether this technique can be performed with the same safety and efficacy as the established cryoballoon ablation (CRYO) in this critically ill patient population. This retrospective, international, multicenter study compares the efficacy and safety of PFA versus CRYO in patients with AF and HFrEF (LVEF ≤40%) undergoing a first-time PVI-only procedure. Using propensity-score matching to minimize selection bias, the study will retrospectively evaluate whether a non-thermal PFA approach is non-inferior to the established thermal CRYO technique regarding rhythm control, while comparing procedural safety and efficiency in this high-risk population. Non-inferiority is tested against the assumption of a 12-month recurrence rate of 30% with a prespecified non-inferiority margin of 12% (corresponding to a hazard ratio of 1.53).

Conditions

• Atrial Fibrillation
• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
PROCEDURE	PVI	pulmonary-vein isolation

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-12-31
• Completion: 2026-02-01
• First posted: 2025-09-18
• Last updated: 2026-02-13

Locations

12 sites across 2 countries: Canada, Germany