N/A
N=5
OFDI Capsule Imaging in Patients With Atrial Fibrillation Undergone Radio Frequency (RF) Ablation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02204566 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OFDI Capsule (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule |
1 | — |
Summary
12 patients with Atrial Fibrillation, a kind of irregular heart beat who have undergone Radio frequency (RF) ablation will be asked to swallow the capsule.
As they swallow the capsule, images of the esophagus will be taken to see if the RF ablation caused any form of damage to the esophagus considering it being so close to the heart.
After the capsule has been removed from the mouth, they will be asked about the tolerability of the capsule.
Eligibility Criteria
Inclusion Criteria
- Subjects must be over 18 years of age
- Subjects must be able to give informed consent.
- Subjects must be referred to Massachusetts General Hospital (MGH) endoscopy for RF Ablation treatment of their Atrial Fibrillation.
Exclusion Criteria
- Subjects with current esophageal strictures and dysphagia
- OR subjects with a prior history of intestinal strictures, prior GI surgery or intestinal Crohn's disease.
- OR subjects with a known history of chronic aspiration.
- OR women who are currently pregnant.
Data sourced from ClinicalTrials.gov (NCT02204566). 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.