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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | PillCam ESO Capsule Endoscope - all patients receive capsule endoscopy before and after RFA procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillCam ESO Capsule Endoscope | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA | 14 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milan Dodig, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy | Posted | Count of Participants | Participants | 14 days |
|
|
3 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Discomfort | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Vargo | Cleveland Clinic | (216) 445-5012 | vargoj@ccf.org |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA | Posted | Count of Participants | Participants | 14 Days |
|
|
|
| 0 |
| 88 |
| 0 |
| 88 |
| 30 |
| 88 |
| Throat Pain | General disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain | General disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
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