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Completed

NCT Number: NCT07181291

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

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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Failure With Reduced Ejection Fraction Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver General Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PVI

Procedure

pulmonary-vein isolation

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

    Time frame: 12 months

    First documented clinical recurrence of any atrial arrhythmia

Secondary outcomes

  1. Number of patients with a rehospitalization (≥ 1 night) due to atrial arrhythmia/ re-ablation or electrical cardioversion starting from day 1 post index procedure

    Time frame: 12 months

  2. Number of patients with a rehospitalization (≥ 1 night) due to worsening heart failure

    Time frame: 12 months

  3. Death from any cause

    Time frame: 12 months

  4. Number of subjects with procedure-associated complications

    Time frame: 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

Sponsors and collaborators

Lead sponsor

St. Josefs-Hospital Wiesbaden GmbH

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 18, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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