AFIDA-2

JRCT ID: jRCTs052240194

Registered date:26/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ischemic stroke, transient ischemic attack, non-valvular atrial fibrillation
• Date of first enrollment: 26/11/2024
• Target sample size: 180
• Study type: Interventional
• Intervention(s): Percutaneous left atrial appendage closure

Outcome(s)

• Primary Outcome: Incidence of the composite outcome of recurrent ischemic stroke /systemic embolism within 48 weeks of enrollment

Secondary Outcome

1)Incidence of composite outcome of stroke and systemic embolism within 48 weeks of enrollment
2)Incidence of stroke within 48 weeks of enrollment
3)Incidence of disabling stroke (change in mRS>=2) within 48 weeks of enrollment
4)Incidence of recurrent ischemic stroke within 48 weeks of enrollment
5)Incidence of recurrent disabling ischemic stroke (change in mRS>=2) within 48 weeks of enrollment
6)Incidence of systemic embolism within 48 weeks of enrollment
7)Incidence of cardiovascular death within 48 weeks of enrollment
8)Incidence of unexplained death within 48 weeks of enrollment
9)Incidence of cardiovascular death or unexplained death within 48 weeks of enrollment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients with ischemic stroke or transient ischemic attack (TIA) within 28 days of onset
2)Patients with NVAF who receive oral anticoagulation at the time of onset
3) Patients deemed eligible for short-term (approximately 45 days) anticoagulant therapy by a physician in advance
4)Patients with medical reasons for not being able to receive anticoagulation for an extended period of time
5)Patients 18 years or older at the time of informed consent
6)Patients for whom written informed consent has been obtained from the person or proxy

Exclude criteria

1)Patients after mechanical valve replacement
2)Patients with severe mitral stenosis
3)Patients who have already participated or will participate in other clinical trials
4)Patients with contraindications to the use of percutaneous LAA closure system
5) Pregnant women, lactating women, or women who cannot consent to contraception during trial participation
6)Patients considered by the investigators to be inappropriate to participate in this trial for other reasons

Related Information

• Primary Sponsor: Koga Masatoshi
• Source(s) of Monetary Support: Boston Scientific Japan Co., Ltd.