Patients with atrial fibrillation after replacement with bioprosthetic valve.
Conditions
Interventions
None listed
Sponsors
National Cerebral and Cardiovascular Center DAIICHI SANKYO CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who 3 months have passed after replacement with bioprosthetic valve (Aortic or Mitral valve replacement, surgical operation or TAVI) 2) Patients who have been given the definitive diagnosis of atrial fibrillation 3) Patients who can follow-up the data over 1 year during the observation period 4) Patients who are able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients currently participating or scheduled to participate in intervention studies 2) Patients who are judged by research director as valvular atrial fibrillation 3) Any patients who are deemed inappropriate by research director or co-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of stroke/systemic embolism and major bleeding during the observation period | — |
Secondary
| Measure | Time frame |
|---|---|
| the rates of the following events: stroke; systemic embolism; ischemic stroke; hemorrhagic stroke; intracranial hemorrhage; cardiovascular events (including myocardial infarction, stroke, systemic embolism, and death from bleeding); and bleeding events (including clinically significant bleeding and minor bleeding) | — |
Countries
Japan
Contacts
Public ContactChisato Izumi
National Cerebral and Cardiovacular Center Department of Cardiovascular Medicine
Outcome results
None listed