臨床研究等提出・公開システム

Left atrial appendage closure for Atrial Fibrillation-Related Ischemic Stroke Despite Anticoagulation-2 (AFIDA-2)

AFIDA-2 (AFIDA-2)

Koga Masatoshi

National Cerebral and Cardiovascular Center

6-1 Kishibe-Shimmachi, Suita, Osaka

koga@ncvc.go.jp

Tanaka Kanta

Kindai University Hospital

1-14-1 Miharadai, Minami-ku, Sakai, Osaka

+81-72-288-7222

tanaka19830311kanta@gmail.com

Not Recruiting

Nov. 26, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

prevention purpose

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

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

Both

Ischemic stroke, transient ischemic attack, non-valvular atrial fibrillation

Percutaneous left atrial appendage closure

Ischemic stroke, transient ischemic attack, non-valvular atrial fibrillation

Percutaneous left atrial appendage closure

D000083242, D002546, D001281

D000097546, D000925

Incidence of the composite outcome of recurrent ischemic stroke /systemic embolism within 48 weeks of enrollment

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

+81-6-6170-1070

Oct. 04, 2024

none