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)

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).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Procedure: PVI

• Study Type: Observational
• Enrollment (Actual): 700

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Vancouver General Hospital
  • Quebec
    • Montreal, Quebec, Canada
      • Montreal Heart Institute
• Germany
  • Bad Nauheim, Germany
    • Kerckhoff-Klinik Bad Nauheim
  • Berlin, Germany
    • Vivantes Klinikum Am Urban
  • Düsseldorf, Germany
    • Evangelisches Krankenhaus Düsseldorf
  • Frankfurt am Main, Germany
    • Universitatsklinikum Frankfurt am Main
  • Fürth, Germany
    • Klinikum Fürth
  • Hagen, Germany
    • Evangelisches Krankenhaus Hagen-Haspe
  • Hamburg-Eppendorf, Germany
    • Universitätsklinikum Hamburg-Eppendorf
  • Hanover, Germany
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany
    • Universitätsklinikum Heidelberg
  • Wiesbaden, Germany
    • St. Josefs-Hospital Wiesbaden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation and heart failure (LVEF ≤ 40%)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cryoballoon pulmonary-vein isolation; Electrical isolation of the pulmonary-veins using cryoenergy	Procedure: PVI; pulmonary-vein isolation
Pulsed field pulmonary-vein isolation; Electrical isolation of the pulmonary-veins using pulsed field energy	Procedure: PVI; pulmonary-vein isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with a clinical recurrence of any atrial arrhythmia (AF, atrial flutter, atrial tachycardia) occurring more than 8 weeks post-intervention	First documented clinical recurrence of any atrial arrhythmia	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death from any cause		12 months
Number of subjects with procedure-associated complications	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	30 days
Number of patients with a rehospitalization (≥ 1 night) due to atrial arrhythmia/ re-ablation or electrical cardioversion starting from day 1 post index procedure		12 months
Number of patients with a rehospitalization (≥ 1 night) due to worsening heart failure		12 months

Collaborators and Investigators

• Sponsor: St. Josefs-Hospital Wiesbaden GmbH
• Investigators: Principal Investigator: Joachim Ehrlich, MD, St. Josefs-Hospital Wiesbaden GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: September 11, 2025
• First Submitted That Met QC Criteria: September 11, 2025
• First Posted (Actual): September 18, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: PFA vs CRYO for AF-HFrEF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No