Exploratory Study to Evaluate the Effect of Uninterrupted Anticoagulants in Catheter Ablation Procedure for Non-valvular Atrial Fibrillation - Comparison between Rivaroxaban and Warfarin
Phase 4
- Conditions
- on-valvular Atrial Fibrillation
- Registration Number
- JPRN-UMIN000013341
- Lead Sponsor
- Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who fulfill at least one of the following criteria 1. Has a history of a prior stroke or TIA within 6 months before enrollment 2. Has a history of a major bleeding within 12 months before enrollment 3. Has had major surgery including CABG within 6 months before enrollment 4. Has a history of a MI within 2 months before catheter ablation procedure 5. Has a CrCl < 30 mL/min at screening 6. Has a diagnosis or clinical condition requiring use of dual anti-platelet therapy 7. Has contraindications of rivaroxaban or warfarin 8. Be a patient judged as "inappropriate" by an investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the incidence of asymptomatic cerebral infarction caused by catheter ablation
- Secondary Outcome Measures
Name Time Method 1. the occurrence of post-procedural (30-40 days) major bleeding event 2. the occurrence of post-procedural (30-40 days) thromboembolic event