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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: OFDI Capsule

• Registration Number: NCT02204566
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-30
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2019-07-30
• Results First Submitted QC: 2019-07-30
• Results First Posted: 2019-08-26
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-24
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OFDI Capsule Imaging	OFDI Capsule	Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.

Primary Outcome Measures

Name	Time	Method
Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule	After the completed imaging session	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States