Non-valvular atrial fibrillation patients scheduled to undergo the catheter ablation procedure
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Non-valvular atrial fibrillation patients scheduled to undergo the catheter ablation procedure and to have been receiving rivaroxaban for at least 3 weeks at the time of admission for catheter ablation procedure
Exclusion criteria
Exclusion criteria: Patients for whom catheter ablation for atrial fibrillation is contraindicated Patients with a history of thromboembolism or myocardial infarction within 2 months prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of thromboembolic events and major bleedings within 1 month since catheter ablation procedure -Thromboembolic events; transient ischemic attack, ischemic stroke, non-CNS systemic embolism - Major bleeding; pericardial effusion requiring a drainage procedure (cardiac tamponade),puncture hematoma requiring surgery, other bleeding episodes requiring blood transfusion, intracranial hemorrhage | — |
Secondary
| Measure | Time frame |
|---|---|
| - Thromboembolism within 1 month since catheter ablation procedure - Major bleeding within 1 month since catheter ablation procedure - Non-major bleeding within 1 month since catheter ablation procedure - Composite of thromboembolism and major bleeding within 1 month since catheter ablation procedure in a group of patients for whom the oral anticoagulation therapy was interrupted on the day of catheter ablation (interrupted regimen group) and in another group for whom the oral anticoagulation therapy was administered on the day of catheter ablation procedure (uninterrupted regimen group) - Non-major bleeding within 1 month since catheter ablation procedure in a group of patients for whom the oral anticoagulation therapy was interrupted on the day of catheter ablation (interrupted regimen group) and in another group for whom the oral anticoagulation therapy was administered on the day of catheter ablation (uninterrupted regimen group) | — |
Countries
Japan
Contacts
Bell Medical Solutions, Inc. Clinical Research and Development Division