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New stepwise ablation method may reduce esophageal injury in AF patients

NCT ID NCT07354737

Disease control Sponsor: Ajou University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a voltage-guided stepwise ablation strategy against the standard circumferential approach for treating atrial fibrillation. 130 adults with AF undergoing their first catheter ablation were randomly assigned to one of the two methods. The goal was to see if the stepwise technique could achieve similar heart rhythm control while potentially causing fewer esophageal injuries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radiofrequency ablation catheter system
What this could lead to
If successful, this approach could reduce the risk of esophageal injury during atrial fibrillation ablation while still effectively controlling the heart rhythm.
What could go wrong
This is a completed trial with 130 participants, so results are limited in size. The stepwise method may not be as effective as standard ablation for preventing arrhythmia recurrence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

130 people

The number who actually took part.

Started

Apr 2021

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (AF) Atrial fibrillation ablation procedure Atrial tachyarrhythmia recurrence Esophageal thermal injury

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

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