N/A
Completed N=36
Evaluation of the CIRCA Monitoring System in Prevention of Esophageal Lesions Following RFCA
Source: ClinicalTrials.gov NCT02467166 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Number of Esophageal Lesions. — 1 esophageal lesions
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Esophageal Lesions. |
1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02467166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.