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

St. Josefs-Hospital Wiesbaden GmbH

Status: Active, not recruiting

Conditions: Atrial Fibrillation; Heart Failure With Reduced Ejection Fraction

Treatments: Procedure: PVI

Study type: Observational

Funder types: Other

Identifiers

NCT07181291

PFA vs CRYO for AF-HFrEF

Details and patient eligibility

About

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 (CBA) in this critically ill patient population.

This research project aims to retrospectively compare, in a multicenter study, PVI using PFA and CBA in patients with AF and concomitant HFrEF based on pre-collected pseudonymized patient data through propensity score matching.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with paroxysmal or persistent AF and echocardiographically confirmed HFrEF (LVEF ≤ 40%)
2. Patients who underwent their first PVI using pulsed field or cryoballoon ablation as part of clinical routine
3. Patients with regular follow-up via 12-lead ECG or Holter ECG following PVI
4. Patients with at least three months of follow-up

Exclusion criteria

1. Patients who did not undergo pulsed field or cryoballoon ablation for first-time PVI
2. Patients with LVEF > 40%
3. Patients who declined the use of their data during initial collection

Trial design

500 participants in 2 patient groups

Cryoballoon pulmonary-vein isolation

Description:

Electrical isolation of the pulmonary-veins using cryoenergy

Treatment:

Procedure: PVI

Pulsed field pulmonary-vein isolation

Description:

Electrical isolation of the pulmonary-veins using pulsed field energy

Treatment:

Procedure: PVI