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Could cooling the esophagus make heart ablation safer?

NCT ID NCT06354777

Knowledge-focused Sponsor: Heart Rhythm Clinical and Research Solutions, LLC 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether actively cooling the esophagus during a common heart procedure (ablation for atrial fibrillation) helps improve outcomes and reduce side effects. Researchers will follow 312 adults with symptomatic atrial fibrillation who are already scheduled for ablation with esophageal cooling. They will track heart rhythm, side effects, and patient-reported symptoms for up to 12 months.

What this could mean

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

Active substance
active esophageal cooling (device-based cooling of the esophagus during ablation)
What this could lead to
If successful, this could show that cooling the esophagus during ablation reduces complications and improves recovery for people with atrial fibrillation.
What could go wrong
This is an observational sub-study, not a randomized trial, so results may not prove cause and effect. The findings are limited to short-term follow-up and may not apply to all patients.

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.

Participants

312 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

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.

Who is studied

The sub-study will consist of consecutive male and female patients enrolled in the REAL AF Registry who have symptomatic Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) and undergo left atrial ablation for the treatment of atrial fibrillation.

Ages

18 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: * Symptomatic Paroxysmal Atrial Fibrillation (AF episode terminate spontaneously within 7 days) or Persistent Atrial Fibrillation (AF sustained beyond 7 days) who, in the opinion of the investigator, are scheduled for ablation for Atrial Fibrillation with active esophageal cooling. * \>18 years of age * Index or redo ablation procedure and enrolled in the REAL AF Registry * Willing and able to provide informed consent and complete GERD questionnaire. Exclusion Criteria: * For the purpose of this sub-study, candidates will be excluded if they meet any of the following criteria: * Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan. * In the opinion of the investigator, any known contraindication to an ablation procedure. * \<18 years of age

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation

Contacts and locations

Locations

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension St. Vincent Hospital Indianapolis

    Indianapolis, Indiana, 46260, United States

  • Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • Corewell Health Research Institute

    Royal Oak, Michigan, 48067, United States

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington, 98001, United States

  • Valley Heart Rhythm Specialists

    Chandler, Arizona, 85224, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.