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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-02-01

Brief Summary

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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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Detailed Description

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Conditions

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Atrial Fibrillation Heart Failure With Reduced Ejection Fraction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cryoballoon pulmonary-vein isolation

Electrical isolation of the pulmonary-veins using cryoenergy

PVI

Intervention Type PROCEDURE

pulmonary-vein isolation

Pulsed field pulmonary-vein isolation

Electrical isolation of the pulmonary-veins using pulsed field energy

PVI

Intervention Type PROCEDURE

pulmonary-vein isolation

Interventions

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PVI

pulmonary-vein isolation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No