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

Mass General Brigham

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: OFDI Capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02204566

2012-P-001952

5R01CA103769-08 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

OFDI Capsule Imaging

Experimental group

Description:

Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.

Treatment:

Device: OFDI Capsule