Nonvalvular atrial fibrillation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: patients with nonvalvular atrial fibrillation who have a high risk of stroke and systemic embolism, based on the CHADS2 or CHA2DS2-VASc scores and a high risk of bleeding with at least one following condition. - Patients with a HAS-BLED score of 3 or higher - Patients with a history of trauma associated with a fall that required treatment for multiple injuries - Patients with a history of diffuse cerebral amyloid angiopathy - Patients who require the concomitant use of two or more antiplatelet agents for an extended period of time (more than 1 year) - Patients with a history of major bleeding that meets the BARC type 3 criteria
Exclusion criteria
Exclusion criteria: 1. patients requiring long-term use of oral anticoagulants for reasons other than non-valvular atrial fibrillation (e.g., patients with implanted mechanical prosthetic valves, patients with hypercoagulable states, or patients with recurrent DVT) 2. patients with evidence of intracardiac (especially intra-atrial) thrombus. 3. patients with atrial septal defect or foramen ovale repair (surgery, device implantation, etc.), or patients with atrial septal defect or foramen ovale repair (surgery, device implantation, etc.). Patients with a history of atrial septal defect or atrial septal suture closure. 4. patients with anatomical structures of the left ventricular ear that are not amenable to closure devices. 5. patients with contraindications to left ventricular closure (transesophageal echocardiography (TEE)) or patients with contraindications to left ventricular closure (e.g., difficulty in inserting transesophageal echocardiography (TEE) probe or catheter required for the procedure). 6. patients with contraindications to anticoagulation, aspirin, or thienopyridine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause death | — |
Secondary
| Measure | Time frame |
|---|---|
| cardiovascular death, ischemic stroke, major bleeding event | — |
Countries
Japan
Contacts
Kokura Memorial Hospital Department of Cardiology