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

Study Overview
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Brief Summary
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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.

Detailed Description
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Dr. Gregory Feld, M.D. is conducting a research study to find out more about the short-term effects on the esophagus of left atrial ablation (guided by Circa™ esophageal temperature monitoring system). The financial supporter of this study is Circa Scientific, LLC. When the investigators perform a radiofrequency catheter ablation (RFCA) at UCSD, the investigators routinely use the Circa™ temperature monitor system to prevent damage to the esophagus. For this study, patients will receive an esophagoscopy, a procedure in which a flexible tube with a camera is inserted through the mouth into the esophagus. The esophagoscopy will be conducted the next day following the ablation procedure to examine the lining of the esophagus for possible lesions or damage. Patients are asked to participate in this study because they are scheduled to have an ablation for atrial fibrillation (AF). There will be approximately 40 participants in this study at the University of California, San Diego (UCSD) Cardiovascular Center. The use of the Circa™ temperature monitoring system used in standard ablation procedures at UCSD and will be used whether or not patients decide to participate in this study. Using esophagoscopy, this study will evaluate the lining of the esophagus, or swallowing tube between the throat and stomach, the day following atrial fibrillation ablation by using an endoscope, flexible tube equipped with a camera. Patients enrolled in the study will proceed to their standard of care ablation procedure for treatment of atrial fibrillation. There will be no changes to the ablation as part of this research study. The Circa™ temperature monitor system will be used throughout the ablation as is standard clinical care for all patients receiving AF ablations at UCSD. For research purposes only, patients will undergo an esophagoscopy, or endoscopic evaluation of the esophagus, the next day following the atrial fibrillation ablation. This procedure will take 40-45 minutes, and will involve inserting a flexible probe (tube) with a camera, into the throat and esophagus (swallowing tube), where it will be inspected for any damage (thermal lesions) caused during the ablation procedure. Following the procedure, patients will be monitored in the usual fashion in the procedure treatment unit (PTU), as is standard of care following AF ablation. Ablation patients will be discharged from the hospital in a standard manner after esophagoscopy and asked to schedule a follow-up appointment following ablation, as is standard of care. There will not be any research follow-up for this study. If for any reason patients cannot complete the ablation or esophagoscopy procedure, patient will be withdrawn from study.

Official Title
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A Prospective, Non-Randomized Study to Evaluate the CIRCA Esophageal Temperature Monitoring System in Prevention of Esophageal Lesions Following Atrial Fibrillation Radiofrequency Catheter Ablation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Circa™ Probe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Circa™ Probe<br>The Circa™ Probe will be used during the RFCA to monitor esophageal temperature. Following ablation, the esophagoscopy will be performed to examine the esophagus for resulting thermal lesions. | Device: Circa™ Probe<br>* The Circa™ probe will be used to monitor esophageal temperature and guide ablation power and duration during the RFCA procedure. Following ablation esophagoscopy will be performed to assess for esophageal lesions.<br>* Other names: K112376;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Esophageal Lesions. | The number of esophageal lesions observed by esophageal endoscopy after left atrial radiofrequency catheter ablation for atrial fibrillation. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AF, esophagoscopy, atrial fibrillation ablation, radio frequency catheter ablation, esophageal lesion, arrhythmia, atrial fibrillation, esophageal damage