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

NCT02204566 | Completed Results

• 2 other identifiers: 2012-P-0019525R01CA103769-08
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

OFDI; RF Ablation; Atrial Fibrillation; Imaging; Esophagus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

OFDI Capsule Imaging

EXPERIMENTAL

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

Device: OFDI Capsule

Interventions

OFDI Capsule DEVICE

Imaging of the esophagus using the OFDI Capsule and system

OFDI Capsule Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Gary Tearney, PI
• Organization: Massachusetts General Hospital

GTEARNEY@PARTNERS.ORG

617-724-2979

Study Officials

• Guillermo Tearney, MD., PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pathology

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: July 30, 2014
• Study Start: January 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 8, 2019
• Results First Posted: August 26, 2019

Record last verified: 2019-10

Locations

US (1)