NCT07034378

Comparison Between Extended Cryoablation, Standard Cryoablation, and Radiofrequency Ablation

Comparison of Extended Cryoballoon Ablation, Standard Cryoballoon Ablation, and Radiofrequency Catheter Ablation in Patients With Persistent Atrial Fibrillation: A Multicenter, Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to test the efficacy hypothesis that extended cryoballoon ablation is superior to either standard cryoballoon ablation or radiofrequency ablation

Detailed description

The posterior wall of the left atrium is known to contribute to arrhythmogenicity and has been associated with higher rates of atrial fibrillation (AF) recurrence. In this trial, we aim to evaluate whether extended cryoballoon ablation-comprising pulmonary vein isolation (PVI) plus posterior wall isolation-results in superior rhythm outcomes compared to standard cryoballoon ablation (PVI only) or radiofrequency ablation (PVI only). Patients will be randomly assigned to one of three treatment arms: extended cryoballoon ablation, standard cryoballoon ablation, or radiofrequency ablation. Each patient will receive the assigned treatment accordingly. The primary outcome is the incidence of atrial tachyarrhythmias-including atrial fibrillation, atrial flutter, and atrial tachycardia-lasting more than 30 seconds, occurring after discontinuation of antiarrhythmic drugs and following a 3-month post-procedure blanking period. Outcomes will be compared at 1 year after the procedure.

Conditions

• Atrial Fibrillation, Persistent

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency ablation	Radiofrequency ablation of pulmonary veins
PROCEDURE	Extended cryoballoon ablation	Cryoablation of pulmonary veins + posterior wall isolation
PROCEDURE	Standard cryoballoon ablation	Standard cryoablation of pulmonary veins

Timeline

• Start date: 2021-09-28
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

3 sites across 1 country: South Korea