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Withdrawn: It was decided not to proceed with the study at this time.
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| Johns Hopkins University | OTHER |
| London Health Sciences Centre | OTHER |
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Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with warfarin are well established, the relative risk and benefit of dabigatran in this setting are unknown. The purposes of the study are to assess the efficacy of warfarin versus dabigatran in the prevention of stroke and other systemic embolic complications before and after catheter ablation for AF, and to compare the prevalence of serious bleeding complications with the two OAC agents.
Patient data sets will be de-identified and compiled
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dabigatran group | All patients receiving dabigatran as periprocedural anticoagulation during the study time period | ||
| warfarin group | A randomly selected group of patients treated with warfarin during the study time period matching the number of dabigatran treated patients in the same time period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical stroke, TIA or systemic embolic complication | Thromboembolic complication recorded in clinical records. | 30 days before or after catheter ablation |
| Bleeding complication | Any bleeding causing additional intervention, hospitalization or pain and suffering including pericardial tamponade, large hematoma or other bleeding. | 30 days before or after catheter ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Any significant complication | Any significant complication that is related to the catheter ablation procedure or to the anticoagulation regimen | 30 days before or after catheter ablation |
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Inclusion Criteria:
Exclusion Criteria:
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All patients undergoing catheter ablation for atrial fibrillation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Health System | Royal Oak | Michigan | 48073 | United States |
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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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| D013568 |
| Pathological Conditions, Signs and Symptoms |