Japanese Anti-Coagulation Regimen Exploration in AF Catheter Ablation Registry - Warfarin cohort Extensio
- Conditions
- Patients enrolled in "the previous study"who have not declared refusal to participation in this study according to an opt-out policy. "The previous study"Patients with nonvalvular atrial fibrillation [NVAF] who undergo catheter ablation.
- Registration Number
- JPRN-UMIN000032830
- Lead Sponsor
- Reimeikyo
- Brief Summary
ong-term incidence of thromboembolism was extremely low in patients with AF treated with CA, while that of major bleeding was not necessarily low.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 152
Not provided
Patients will be excluded from the study if any of the following conditions apply. 1]Contraindication to ablation therapy for the treatment of atrial fibrillation [e.g., due to a preoperative transesophageal echocardiography, CT, or MRI finding of a thrombus in the left atrium/left atrial appendage]. 2]Development of thromboembolism or myocardial infarction within 2 months before enrollment. 3]Contraindication to Rivaroxaban. 4]For a study site that is allowed to omit the procedure of obtaining written informed consent, a patient who declares refusal to enrollment in the study will be excluded. 5]Current participation in another interventional clinical study. 6]The investigator's judgement that the patient will be inappropriate for participation in the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The combination of thromboembolism and serious bleeding during the late postoperative period after one month from catheter ablation. - Thromboembolism: including transient ischemic attack, cerebral infarction, and other kinds of systemic embolism. - Serious bleeding.
- Secondary Outcome Measures
Name Time Method Occurrence (recurrence) of atrial fibrillation during the late postoperative period after one month from catheter ablation Presence or absence of repeated ablation during the late postoperative period after one month from catheter ablation and its details Stroke (ischemic)/TIA during the late postoperative period after one month from catheter ablation Stroke (hemorrhagic) during the late postoperative period after one month from catheter ablation Cardiovascular events during the late postoperative period after one month from catheter ablation Serious bleeding during the late postoperative period after one month from catheter ablation Not serious but clinically significant bleeding during the late postoperative period after one month from catheter ablation Presence or absence of discontinuation of anticoagulant therapy during the late postoperative period after one month from catheter ablation.