N/A
Completed N=93
Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment
Esophageal Lesion
Source: ClinicalTrials.gov NCT00990782 ↗
Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy — 15 Participants
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 established.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy |
15 | — |
| SECONDARY Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Symptomatic patients with persistent atrial fibrillation selected for radiofrequency ablation
- Adults aged 18 years and older
- Patients able to give informed consent
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00990782). 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.