Status:
COMPLETED
Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Esophageal Lesion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been e...
Detailed Description
Patients undergoing radiofrequency ablation (RFA) therapy for atrial fibrillation, can sometimes experience insult or injury to the esophagus, due to the proximity of the esophagus to the RFA treatmen...
Eligibility Criteria
Inclusion
- Symptomatic patients with persistent atrial fibrillation selected for radiofrequency ablation
- Adults aged 18 years and older
- Patients able to give informed consent
Exclusion
- Patients under the age of 18
- Patient unable to or unwilling to swallow the capsule endoscopes
- Patients with cardiac pacemakers, implanted cardiac defibrillators or other implanted electro-medical devices
- Pregnant or lactating females
- Subjects with history of abdominal, pelvic, or bowel surgery within the past year
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00990782
Start Date
September 1 2009
End Date
September 1 2010
Last Update
July 2 2017
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195