Evaluation of the CIRCA Monitoring System in Prevention of Esophageal Lesions Following RFCA

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

The purpose of this study is to determine if the use of Circa™ temperature monitoring system during ablation procedures will reduce the risk of esophageal lesions or damage. Esophageal lesions caused by ablation could later develop into a potentially fatal atrio-esophageal fistula, which is hole between the upper chamber of the heart and the esophagus. Although development of atrio-esophageal fistula following atrial fibrillation ablation is extremely rare, the complication is severe and potentially life-threatening. Therefore, monitoring of esophageal temperatures has been adopted to prevent the development of esophageal lesions. The Circa™ temperature monitoring system allows cardiac electrophysiologists to monitor and thereby limit temperatures as well as duration of ablation in the esophagus throughout the procedure.

Key facts

Study ID

NCT02467166

Run by

University of California, San Diego

People needed

40

Starts

2015-06-01

Expected to finish

2020-05-05

Last updated by the study team

2021-06-02

Who can join

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

You may qualify if…

• Must have atrial fibrillation and be scheduled for AF ablation, during which the Circa esophageal temperature probe will be used to guide ablation.
• Must give written informed consent

You may not qualify if…

• Patient's refusal to participate in the study
• Any known esophageal disease or prior injury that would preclude esophagoscopy
• Any complications occuring during or after AF ablation that would result in esophagoscopy being an added significant risk to the patient beyond the known potential risks from the esophagoscopy
• Prior AF ablation

Where it is running

• Sulpizio Cardiovascular Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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