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

NCT07354737 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-01-22

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Fibrillation (AF)
  • Atrial Fibrillation Ablation Procedure
  • Atrial Tachyarrhythmia Recurrence
  • Esophageal Thermal Injury

Interventions

DEVICE

Radiofrequency ablation catheter system

Catheter ablation for atrial fibrillation performed using a voltage-guided stepwise PVI strategy. Ablation is delivered point-by-point along a predefined antral line, starting at higher-voltage sites and expanding stepwise to lower-voltage sites only as needed until pulmonary vein isolation is achieved. Additional potential-guided ablation may be performed if required to complete isolation.

DEVICE

Radiofrequency ablation catheter system

Catheter ablation for atrial fibrillation performed using a conventional circumferential antral PVI strategy. A continuous circumferential lesion set is created around the pulmonary vein antrum to achieve isolation. Additional potential-guided ablation may be performed if required to complete isolation.

Sponsors & Collaborators

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • Kwang-No Lee, MD, PhD · Ajou University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2025-01-22
Completion
2025-01-22
FDA Device
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07354737 on ClinicalTrials.gov