Skip to content

AFIDA-2

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052240194
Enrollment
180
Registered
2024-11-26
Start date
2024-12-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Percutaneous left atrial appendage closure
D000097546, D000925

Sponsors

Koga Masatoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Contacts

Public ContactKanta Tanaka

Kindai University Hospital

tanaka19830311kanta@gmail.com+81-72-288-7222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026