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Esophageal Protection Study: A Multicenter Study
NCT04577859 · View on ClinicalTrials.gov ↗
Study Summary
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 p
Conditions Studied
Interventions
- DEVICE ensoETM. Esophageal cooling during AF ablation
- DEVICE Esophageal temperature monitoring probe
Study Locations (6)
Florida
- NCH Research Institute — Naples
Kansas
- Kansas City Cardiac Arrhythmia Research LLC — Overland Park
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
Pennsylvania
- University of Pennsylvania — Philadelphia
Texas
- Texas Cardiac Arrhythmia Research Foundation — Austin
Other
- St.George's Hospital — London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2022-03-10 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04577859
The ClinicalTrials.gov registry entry for NCT04577859 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advanced Cooling Therapy LLC, d/b/a Attune Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Complication appearing as the primary indexed condition, and to 2 interventions — of which ensoETM. Esophageal cooling during AF ablation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04577859 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Florida, Kansas, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04577859 about?
NCT04577859 is a clinical study titled "Esophageal Protection Study: A Multicenter Study". 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...
What is the current status of trial NCT04577859?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 152 participants. The study started on 2022-03-10. Estimated completion is 2026-05-31.
What conditions does trial NCT04577859 study?
This clinical trial studies the following conditions: Complication, AF - Atrial Fibrillation, Atrio-Esophageal Fistula. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04577859?
The interventions under investigation include: ensoETM. Esophageal cooling during AF ablation (DEVICE), Esophageal temperature monitoring probe (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04577859?
This trial is sponsored by Advanced Cooling Therapy LLC, d/b/a Attune Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04577859 being conducted?
This trial has 6 study locations across Florida, Kansas, Massachusetts, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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