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

Active, not recruiting

• Conditions: Atrial Fibrillation; Heart Failure With Reduced Ejection Fraction

• Registration Number: NCT07181291
• Lead Sponsor: St. Josefs-Hospital Wiesbaden GmbH

Brief 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 (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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of subjects with a clinical recurrence of any atrial arrhythmia (AF, atrial flutter, atrial tachycardia) occurring more than 8 weeks post-intervention	36 months	First documented clinical recurrence of any atrial arrhythmia

Secondary Outcome Measures

Name	Time	Method
Number of patients with a rehospitalization (≥ 1 night) due to atrial arrhythmia/ re-ablation or electrical cardioversion starting from day 1 post index procedure	36 months
Number of patients with a rehospitalization (≥ 1 night) due to worsening heart failure	36 months
Death from any cause	36 months
Number of subjects with procedure-associated complications	30 days	Death, Major bleeding (criteria per Bleeding Academic Research Consortium ≥2, treatment-requiring groin complications (including AV fistula, aneurysm, or dissection), pericardial effusion/tamponade, non-fatal stroke/transient ischemic, attack, temporary or persistent phrenic nerve palsy, homeless

Trial Locations

Locations (10)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

Vivantes Klinikum am Urban; 🇩🇪 Berlin, Germany

Universitätsklinikum Frankfurt am Main; 🇩🇪 Frankfurt am Main, Germany

Klinikum Fürth; 🇩🇪 Fürth, Germany

Evangelisches Krankenhaus Hagen-Haspe; 🇩🇪 Hagen, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hanover, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

St. Josefs-Hospital Wiesbaden; 🇩🇪 Wiesbaden, Germany

Maastricht University Medical Center Plus; 🇳🇱 Maastricht, Netherlands