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.
Conditions
Interventions
None listed
Sponsors
Reimeikyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following conditions to be eligible for the study. 1] Diagnosis of nonvalvular atrial fibrillation [NVAF]. NVAF refers to atrial fibrillation without history of rheumatic mitral valve disease, prosthetic valve, or mitral valve repair. 2] Undergoing ablation therapy [radiofrequency ablation only] for the treatment of atrial fibrillation. 3] Receiving rivaroxaban for at least 3 weeks by the time of hospitalization for catheter ablation. 4] Age 20years and older at providing consent. 5] Written informed consent must be obtained from the patient, unless the following condition does not apply. If, upon approval by the Ethics Review Committee, information on the study has been properly disclosed to the target patients through means such as poster presentations in the study site, obtaining written informed consent can be exempted so that the patient will be excluded from the study only when she/he declares refusal to enrollment in the study.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactAkiko Fujihiro
A2 Healthcare Corporation Clinical Development Promotion Dept.
Outcome results
None listed