Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.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 of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to warm the esophagus during left atrial cryoablation.

Key facts

Study ID

NCT04087122

Run by

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

People needed

20

Starts

2019-09-30

Expected to finish

2020-12-31

Last updated by the study team

2022-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (age over 18 years).
• Undergoing cryoablation for the treatment of atrial fibrillation, including pulmonary vein isolation.
• 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.
• Significant co-morbidities that preclude standard ablation procedure.
• Patients with <40 kg of body mass.
• Patients with relevant esophageal pathology (e.g. esophageal cancer).

Where it is running

• Winchester Medical Center — Winchester, Virginia, United States

Full record on ClinicalTrials.gov

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