Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures

NCT04063761 | Completed Results FDA Device

• 1 other identifier: AMEVAB2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Total Time of Active Ablation Procedure

  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.

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

Secondary Outcomes (2)

• Total Procedure Time

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

• Number of Procedural Pauses During Left Atrial Instrumentation

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

Study Arms (1)

Esophageal Cooling

EXPERIMENTAL

Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device

Device: esophageal cooling device (Attune Medical, Chicago, IL)

Interventions

esophageal cooling device (Attune Medical, Chicago, IL) DEVICE

Prospective, single center pilot study

Esophageal Cooling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Advanced Cooling Therapy, Inc., d/b/a Attune Medical: lead
• University of Iowa: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: Attune Medical

info@attune-medical.com

888.534.4873

Study Officials

• Alexander Mazur, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: June 20, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 20, 2021
• Last Updated: June 17, 2025
• Results First Posted: September 7, 2022

Record last verified: 2022-09

Locations

US (1)