Esophageal Lesion
Conditions
Brief summary
This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.
Detailed description
Patients undergoing radiofrequency ablation (RFA) therapy for atrial fibrillation, can sometimes experience insult or injury to the esophagus, due to the proximity of the esophagus to the RFA treatment area. This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.
Interventions
DIAGNOSTIC_TESTPillCam ESO Capsule Endoscope
Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.
Sponsors
Medtronic - MITG
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic patients with persistent atrial fibrillation selected for radiofrequency ablation * Adults aged 18 years and older * Patients able to give informed consent
Exclusion criteria
* Patients under the age of 18 * Patient unable to or unwilling to swallow the capsule endoscopes * Patients with cardiac pacemakers, implanted cardiac defibrillators or other implanted electro-medical devices * Pregnant or lactating females * Subjects with history of abdominal, pelvic, or bowel surgery within the past year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA | 14 Days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PillCam ESO Capsule Endoscope All patients receive capsule endoscopy before and after RFA procedure.
PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation. | 88 |
| Total | 88 |
Baseline characteristics
| Characteristic | PillCam ESO Capsule Endoscope |
|---|---|
| Age, Continuous | 59.5 Years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 88 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 88 |
| other Total, other adverse events | 30 / 88 |
| serious Total, serious adverse events | 0 / 88 |
Outcome results
Primary
Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PillCam ESO Capsule Endoscope | Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy | 15 Participants |
Secondary
Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA
Time frame: 14 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PillCam ESO Capsule Endoscope | Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA | 6 Participants |