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Completed

NCT Number: NCT04063761

Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures

Left atrial catheter ablation including pulmonary vein isolation is a standard therapy in the management of symptomatic atrial fibrillation; however thermal esophageal injury is a known potential consequence of this procedure. Delivery of radiofrequency (RF) energy necessary to perform left atrial ablation has the potential to cause injury to the nearby esophagus including ulceration, hematoma, spasm, esophageal motility disorders, and, in the most extreme case, atrial-esophageal fistula (AEF). Esophageal mucosal lesions are the likely precursor to AEF, and esophageal mucosal lesions have been detected on post-ablation endoscopy after pulmonary vein isolation with an incidence ranging from 3% to 60%.

Active esophageal cooling during RF ablation as a means of esophageal injury prevention has been investigated through mathematical models, pre-clinical studies, and in clinical trials. Existing data support the efficacy of this approach, but the practice has not been widely adopted due to lack of a commercially available device.

The aim or purpose of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to cool the esophagus during left atrial RF ablation.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

This study is a prospective, pilot study using the Attune Medical esophageal heat transfer device to actively cool the esophagus during RF ablation procedures. This design is appropriate to gather the data needed regarding overall procedural time, compare this to historical controls, and estimate a sample size for a larger study powered for statistical significance.

The subjects will undergo preparation and anesthesia procedures following standard practice. Once the patient is intubated, the esophageal heat transfer device will be placed into the esophagus according to the Instructions for Use (IFU). The device will remain in place until the ablation procedure is completed and will be removed before extubation. Posterior left atrial wall ablation using standard parameters will only be performed when the esophageal heat transfer device has reached a temperature of 4-6 degrees C for at least 2 minutes. The device will be set to neutral or warming temperature (37-42 degrees C) during other aspects of the procedure (such as mapping and anterior wall ablations).

All patients will be followed up in total for 6 weeks (Long Term Follow-up visit) after the procedure to document any clinical complication related to thermal esophageal injuries if applicable.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (age over 18 years)
  • Undergoing first left atrial ablation for the treatment of atrial fibrillation (AF) including pulmonary vein isolation
  • Undergoing catheter-based ablation procedure using radiofrequency energy
  • Patients must be able to understand and critically review the informed consent form.
  • Subjects must understand and agree to study requirements and sign a written informed consent.

Exclusion criteria

  • Patients who are unable to provide informed consent.
  • History of prior atrial fibrillation (AF) ablation procedures.
  • Significant co-morbidities that preclude standard ablation procedure.
  • Patients with <40 kg of body mass
  • Patients with relevant esophageal pathology (e.g. esophageal cancer)

Treatment and study plan

esophageal cooling device (Attune Medical, Chicago, IL)

Device

Prospective, single center pilot study

Primary outcomes

  1. Total Time of Active Ablation Procedure

    Time frame: Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours

    Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours. Measured as total procedure time as documented by clinician recorder and research coordinator.

Secondary outcomes

  1. Total Procedure Time

    Time frame: Study Day 1 for all patients enrolled from patient entry to Electrophysiology (EP) lab until post procedure discharge to Post-Anesthesia Care Unit (PACU)

    Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours after procedure. Measured as total procedure time to discharge to PACU as documented by clinician recorder and research coordinator.

  2. Number of Procedural Pauses During Left Atrial Instrumentation

    Time frame: Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours

    Number of procedural pauses during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)

Sponsors and collaborators

Lead sponsor

Advanced Cooling Therapy, Inc., d/b/a Attune Medical

Industry

Collaborators

  • University of Iowa

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2019
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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