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

NCT07181291 | Completed

• 1 other identifier: PFA vs CRYO for AF-HFrEF
• Study Type: observational
• Target: 700
• Locations: 2 countries
• Sites: 12

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 (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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Death from any cause

  12 months

• Number of subjects with procedure-associated complications

  30 days

Study Arms (2)

Cryoballoon pulmonary-vein isolation

Electrical isolation of the pulmonary-veins using cryoenergy

Procedure: PVI

Pulsed field pulmonary-vein isolation

Electrical isolation of the pulmonary-veins using pulsed field energy

Procedure: PVI

Interventions

PVI PROCEDURE

pulmonary-vein isolation

Cryoballoon pulmonary-vein isolation; Pulsed field pulmonary-vein isolation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Josefs-Hospital Wiesbaden GmbH: lead

Study Sites (12)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

Kerckhoff-Klinik Bad Nauheim

Bad Nauheim, Germany

Location

Vivantes Klinikum am Urban

Berlin, Germany

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Frankfurt am Main

Frankfurt am Main, Germany

Location

Klinikum Fürth

Fürth, Germany

Location

Evangelisches Krankenhaus Hagen-Haspe

Hagen, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg-Eppendorf, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

St. Josefs-Hospital Wiesbaden

Wiesbaden, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joachim Ehrlich, MD

  St. Josefs-Hospital Wiesbaden GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); DE (10)