Esophageal Protection Study: A Multicenter Study

Completed · Not applicable

Conditions studied: AF - Atrial Fibrillation, Complication, Atrio-Esophageal Fistula

In brief

Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the esophagus caused by thermal energy being transmitted to the esophagus from the heart. The esophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe esophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result. In recent studies, it was shown that a more advanced type of esophageal probe (ensoETM) that cools the esophagus during ablation is better at protecting the esophagus from ablation-related injury compared to the standard care temperature monitoring probe currently used. The ensoETM is a CE marked and FDA-cleared device, with an intended purpose of controlling patient temperature and has received marketing authorization from FDA to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures. The purpose of this study is to determine if the long-term efficacy outcome results obtained in single pilot studies can be replicated in a prospective, multi-center randomized controlled trail comparing the the esophageal cooling probe versus a standard of care esophageal temperature monitoring probe. There is a 50:50 chance of the esophageal cooling probe being used during AF ablation for participants.

Key facts

Study ID: NCT04577859
Run by: Advanced Cooling Therapy LLC, d/b/a Attune Medical
People needed: 152
Starts: 2022-03-10
Expected to finish: 2026-05-15
Last updated by the study team: 2026-07-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

AF patients scheduled to have a radiofrequency AF ablation procedure under general anesthesia who pass standard care screening assessments.

You may not qualify if…

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

Where it is running

NCH Research Institute — Naples, Florida, United States
Kansas City Cardiac Arrhythmia Research LLC — Overland Park, Kansas, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States
St.George's Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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