OFDI Capsule Imaging in Patients With Atrial Fibrillation Undergone Radio Frequency (RF) Ablation

Study Overview
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Brief Summary
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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.

Detailed Description
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A total of 12 patients with a known diagnosis of Atrial Fibrillation who have previously undergone Atrial RF ablation will be enrolled in the study. Patients will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done. As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.

Official Title
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Pilot Study of OFDI Capsule Imaging of the Esophagus of Patients With Atrial Fibrillation Following RF Ablation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: OFDI Capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OFDI Capsule Imaging<br>Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. | Device: OFDI Capsule<br>* Imaging of the esophagus using the OFDI Capsule and system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule | An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. A total of 6 subjects were enrolled in this study. 1 participant was not analyzed as they could not attempt to swallow the capsule. | After the completed imaging session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OFDI, RF Ablation, Atrial Fibrillation, Imaging, Esophagus