Esophageal Protection Study: A Multicenter Study
Public ClinicalTrials.gov record NCT04577859. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Improving Esophageal Protection During AF Ablation: a Multicenter Double-blind Randomized Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04577859
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 152 participants
Conditions and interventions
Interventions
- ensoETM. Esophageal cooling during AF ablation Device
- Esophageal temperature monitoring probe Device
Device
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 9, 2022
- Primary completion
- May 14, 2026
- Completion
- May 14, 2026
- Last update posted
- Jul 7, 2026
2022 – 2026
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NCH Research Institute | Naples | Florida | 34102 | — |
| Kansas City Cardiac Arrhythmia Research LLC | Overland Park | Kansas | 66211 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04577859, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 7, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04577859 live on ClinicalTrials.gov.