Atrial Fibrillation
Conditions
Keywords
OFDI, RF Ablation, Atrial Fibrillation, Imaging, Esophagus
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.
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.
Interventions
DEVICEOFDI Capsule
Imaging of the esophagus using the OFDI Capsule and system
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OFDI Capsule Imaging 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 | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | OFDI Capsule Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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.
Time frame: After the completed imaging session
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Feasibility | Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule | 1 Participants |