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

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT02204566

Run by

Massachusetts General Hospital

People needed

6

Starts

2013-01-01

Expected to finish

2015-09-01

Last updated by the study team

2019-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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