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Cooling probe may shield esophagus during heart ablation for AF

NCT ID NCT04577859

Disease control Sponsor: Advanced Cooling Therapy LLC, d/b/a Attune Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial tests whether a special cooling probe placed in the esophagus can protect it from heat damage during a common heart procedure for atrial fibrillation (AF). AF is a heart rhythm disorder that can cause serious symptoms, and ablation uses heat to fix it, but the esophagus sits close by and can be injured. The study compares the cooling probe to a standard temperature monitor in people undergoing AF ablation under general anesthesia, to see if cooling reduces esophageal injury and improves safety.

What this could mean

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

Active substance
ensoETM esophageal cooling probe
What this could lead to
If it works, this could make AF ablation safer by reducing the risk of esophageal injury, a rare but serious complication.
What could go wrong
This is a mid-stage trial; the cooling probe may not prove better than standard care, and any device carries procedural risks.

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

152 people

The number who actually took part.

Started

Mar 2022

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 85 years

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: • AF patients scheduled to have a radiofrequency AF ablation procedure under general anesthesia who pass standard care screening assessments. Exclusion Criteria: * Inability to consent for any reason. * Those in extremities of age (\<18 or \>85) will not be recruited. * AF patients scheduled to have a radiofrequency AF ablation under local anesthesia * Patients who have received a left atrial ablation procedure within the last 90 days. • • Patients enrolled in another clinical trial that might impact participation in this trial. * \*\* For patients electing to undergo the optional endoscopy, no contraindications to endoscopy should be present

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Af - atrial fibrillation Atrio-esophageal fistula Complication

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Kansas City Cardiac Arrhythmia Research LLC

    Overland Park, Kansas, 66211, United States

  • NCH Research Institute

    Naples, Florida, 34102, United States

  • St.George's Hospital

    London, SW170QT, United Kingdom

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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