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

NCT07354737 | Completed DMC FDA Device

• 1 other identifier: AJIRB-MED-INT-20-475
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Atrial fibrillation; Catheter ablation; Pulmonary vein isolation; Voltage-guided ablation; High-density voltage mapping; Segmental ablation; Randomized controlled trial; Noninferiority trial

Outcome Measures

Primary Outcomes (1)

• Atrial tachyarrhythmia recurrence within 12 months after the index ablation

  Recurrence of atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) within 12 months after the index ablation, defined as an episode documented on a 12-lead ECG or lasting ≥30 seconds on ambulatory monitoring (24-72-hour Holter). Events occurring during the 3-month post-ablation blanking period are excluded.

  12 months after the index ablation (excluding a 3-month blanking period)

Study Arms (2)

Voltage-guided Stepwise Pulmonary Vein Isolation (PVI)

EXPERIMENTAL

Participants undergo catheter ablation for atrial fibrillation using a voltage-guided stepwise PVI strategy. Ablation is delivered point-by-point along a predefined antral line, starting in higher-voltage regions and expanding stepwise to lower-voltage regions only as needed until pulmonary vein isolation is achieved. Additional ablation may be performed if required to complete isolation based on residual electrical signals.

Device: Radiofrequency ablation catheter system

Conventional Circumferential Antral Pulmonary Vein Isolation (PVI)

ACTIVE COMPARATOR

Participants undergo catheter ablation for atrial fibrillation using a conventional circumferential antral PVI strategy. A continuous circumferential lesion set is created around the pulmonary vein antrum to achieve isolation. Additional ablation may be performed if required to complete isolation based on residual electrical signals.

Device: Radiofrequency ablation catheter system

Interventions

Radiofrequency ablation catheter system DEVICE

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.

Also known as: Voltage-guided stepwise PVI

Voltage-guided Stepwise Pulmonary Vein Isolation (PVI)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥20 years
• Symptomatic paroxysmal or non-paroxysmal atrial fibrillation
• Scheduled for first-time catheter ablation with pulmonary vein isolation
• Able to provide written informed consent

You may not qualify if:

• Prior catheter or surgical ablation for atrial arrhythmia
• Myocardial infarction within the past 3 months
• Stroke or transient ischemic attack within the past 6 months
• New York Heart Association (NYHA) class III-IV heart failure
• Contraindication to oral anticoagulation
• Pregnancy
• Any medical condition judged by the investigator to make participation unsafe or to interfere with study procedures or follow-up

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kwang-No Lee, MD, PhD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are masked to treatment assignment. Treating physicians/operators are not masked due to the nature of the catheter ablation strategies. Atrial tachyarrhythmia recurrence is assessed using scheduled ECG and ambulatory monitoring and reviewed by treating clinicians who are aware of group allocation. Outcomes assessors for safety endpoints are masked to treatment assignment for evaluation of post-procedure endoscopic findings using prespecified criteria.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are randomized 1:1 to one of two pulmonary vein isolation strategies (voltage-guided stepwise PVI vs conventional circumferential antral PVI) and followed in parallel for 12-month atrial tachyarrhythmia recurrence and safety outcomes.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 21, 2026
• Study Start: April 1, 2021
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years thereafter.
• Access Criteria: Access to de-identified IPD will be provided to qualified researchers upon reasonable request. Requestors must submit a brief research proposal, analysis plan, and evidence of relevant qualifications. Requests will be reviewed by the study team for scientific merit, feasibility, and protection of participant privacy. Access will be granted after execution of a data use agreement and confirmation of institutional ethics approval where required. Data will be shared via a secure method, limited to the minimum necessary dataset, and recipients must agree not to attempt re-identification or share the data with third parties without written permission.

Locations

KR (1)