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NCT02467166 · ClinicalTrials.gov registry record · NA
Evaluation of the CIRCA Monitoring System in Prevention of Esophageal Lesions Following RFCA
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT02467166: Completed NA study, sponsored by University of California, San Diego.
NCT02467166 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02467166, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
The number of esophageal lesions observed by esophageal endoscopy after left atrial radiofrequency catheter ablation for atrial fibrillation.
Interventions
- DEVICE Circa™ Probe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-06 |
| Est. Completion | 2020-05-05 |
| Phase | NA |
What the finished NCT02467166 record still lists
NCT02467166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Circa™ Probe is the first listed.
NCT02467166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02467166 about?
NCT02467166 is a clinical study titled "Evaluation of the CIRCA Monitoring System in Prevention of Esophageal Lesions Following RFCA". 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 bet...
What is the current status of trial NCT02467166?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2015-06. Estimated completion is 2020-05-05.
What interventions are being tested in trial NCT02467166?
The interventions under investigation include: Circa™ Probe (DEVICE).
Who is sponsoring clinical trial NCT02467166?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02467166's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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