NCT07354737Completed
Efficacy and Safety of a Voltage-Guided Stepwise Strategy for Pulmonary Vein Isolation
Efficacy and Safety of a Voltage-Guided Stepwise Strategy for Pulmonary Vein Isolation: A Randomized Comparison With Conventional Circumferential Antral Pulmonary Vein Isolation
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 130 (actual)
- First submitted
- 18 Jan 2026
- Start date
- 1 Apr 2021
- Primary completion date
- 22 Jan 2025
- Lead sponsor
- Ajou University School of Medicine
- Diseases
- Atrial fibrillation
- NCT number
- NCT07354737
What you commit to
- Study type: Interventional
- Participants enrolled: 130
- From 1 Apr 2021 to the primary completion date, 22 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior catheter or surgical ablation for atrial arrhythmia
Other illness
- 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
- Any medical condition judged by the investigator to make participation unsafe or to interfere with study procedures or follow-up
Other
- Contraindication to oral anticoagulation
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.