Efficacy and Safety of a Voltage-Guided Stepwise Strategy for Pulmonary Vein Isolation

The goal of this clinical trial is to learn if a voltage-guided stepwise pulmonary vein isolation (PVI) strategy can achieve effective PVI while potentially reducing lesion delivery, compared with conventional circumferential antral PVI, in adults (≥20 years) with paroxysmal or non-paroxysmal atrial fibrillation undergoing first-time catheter ablation. The main question(s) it aims to answer is/are: Is voltage-guided stepwise PVI non-inferior to conventional circumferential antral PVI for atrial tachyarrhythmia recurrence within 12 months after ablation? Does voltage-guided stepwise PVI differ from conventional circumferential antral PVI in procedural characteristics and safety outcomes, including endoscopically detected esophageal thermal injury and acute procedural complications? Researchers will compare the voltage-guided stepwise PVI arm to the conventional circumferential antral PVI arm to see if the stepwise approach maintains arrhythmia outcomes while changing lesion delivery requirements and safety outcomes. Participants will: Be randomized 1:1 to undergo catheter ablation with either voltage-guided stepwise PVI or conventional circumferential antral PVI. Undergo diagnostic esophagoscopy between post-procedure day 1 and day 3 to systematically assess for esophageal thermal injury. Complete follow-up evaluations at 3, 6, 9, and 12 months (and every 6 months thereafter), including 12-lead ECGs and 24- or 72-hour Holter monitoring.

NCT Number	NCT07354737
Lead Sponsor	Ajou University School of Medicine
Conditions	Atrial Fibrillation (AF), Atrial Fibrillation Ablation Procedure, Atrial Tachyarrhythmia Recurrence, Esophageal Thermal Injury
Enrollment	130 participants
Start Date	2021-04-01
Primary Completion	2025-01-22 (estimated)
Study Completion	2025-01-22 (estimated)
Updated on ClinicalTrials.gov	2026-01-22