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The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation for symptoms and signs of esophageal injury.
The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation and endoscopy. If any signs of esophageal injury are seen on endoscopy the patients will be treated with omeprazole and sucralfate and they will have repeat endoscopy in two weeks. Patients who do not have any esophageal injury will be contacted by telephone in two weeks to be assessed for GI symptoms.
Specific Aims: The specific aims of the study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AF ablation group | Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopy in group I (all patients) | Procedure | Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Esophageal Injury as Assessed by Endoscopy | Endoscopy results and clinical status at one month after endoscopy procedure. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 18-80 scheduled to undergo catheter ablation of atrial fibrillation
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| Name | Affiliation | Role |
|---|---|---|
| Karen Beckman, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OU Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AF Ablation Group | Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. Endoscopy in group I (all patients): Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AF Ablation Group | Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. Endoscopy in group I (all patients): Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Incidence of Esophageal Injury as Assessed by Endoscopy | Endoscopy results and clinical status at one month after endoscopy procedure. | Posted | Number | participants | 1 month |
|
|
Endoscopy one day after ablation Clinical evaluation 1 month after ablation
Adverse events were collected by:
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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 | AF Ablation Group | Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. Endoscopy in group I (all patients): Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophageal erythema | Gastrointestinal disorders | Systematic Assessment | by endoscopy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sunny Po, MD, PhD | University of Oklahoma Health Science Center | 405-271-9696 | Sunny-Po@ouhsc.edu |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 171 |
| 17 |
| 171 |
| 0 |
| 171 |
| Esophageal erosion | Gastrointestinal disorders | Systematic Assessment | by endoscopy |
|
| Esophageal Ulcer | Gastrointestinal disorders | Systematic Assessment | By endoscopy |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 | Surgical Procedures, Operative |