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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02204566
• Collaborator: National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 32
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: OFDI Capsule	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Pilot Study of OFDI Capsule Imaging of the Esophagus of Patients With Atrial Fibrillation Following RF Ablation
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OFDI Capsule Imaging Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.	Device: OFDI Capsule; Imaging of the esophagus using the OFDI Capsule and system

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Guillermo Tearney, MD., PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02204566
• Other Study ID Numbers: 2012-P-001952; 5R01CA103769-08
• First Posted: Jul 30, 2014
• Last Update Posted: Nov 8, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital: OFDI; RF Ablation; Atrial Fibrillation; Imaging; Esophagus
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Arm/Group Title	OFDI Capsule Imaging
Arm/Group Description	Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system
Period Title: Overall Study
STARTED	5
COMPLETED	1
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	OFDI Capsule Imaging
Arm/Group Description	Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system
Overall Participants	5
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 60%
>=65 years	2 40%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62 (7)
Sex: Female, Male (Count of Participants)
Female	3 60%
Male	2 40%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	5 100%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	5 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Feasibility
Arm/Group Description	Number of Participants with Acceptable Quality of Images Who Swallow the OFDI Capsule
Measure Participants	5
Count of Participants [Participants]	1 20%

Adverse Events

Arm/Group Title	OFDI Capsule Imaging
Arm/Group Description	Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system
All Cause Mortality
	OFDI Capsule Imaging
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	OFDI Capsule Imaging
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	OFDI Capsule Imaging
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.