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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204566
• Other study ID #: 2012-P-001952
• Secondary ID: 5R01CA103769-08
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• OFDI Capsule
Imaging of the esophagus using the OFDI Capsule and system

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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