Atrial Fibrillation
Conditions
Interventions
Two groups:Left Atrial Appendage (LAA) occlude: Watchman or ACP device
Duration of intervention: life long vs Nil
Sponsors
SK Yee Funding, CUHK
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults above the age of 18; 2. Non-valvular AF, at high risk of stroke and who have experienced serious bleeding events or repeated nuisance bleed events whilst on warfarin or NOACs; 3. Non-valvular AF, at high risk of stroke and who are intolerant of, has significant side effect, or decline to take warfarin or NOACs; 4. Non-valvular AF, at high risk of stroke and who are poorly compliant with warfarin (Time in therapeutic range <60%) or NOACs; 5. Non-valvular AF, at high risk of stroke and who are at high risk of bleeding as evidenced by a high HAS-BLED score.
Exclusion criteria
Exclusion criteria: 1. Inability to take Aspirin and Clopidogrel; 2. Inability to give informed consent; 3. Patients unlikely to benefit from the therapy due to a short life expectancy; 4. NYHA 4; 5. LVEF <30%; 6. Moderate-to-severe or worse mitral or aortic valvular regurgitation or stenosis; 7. Suspected or known intracardiac thrombus; 8. Symptomatic carotid disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoints: stroke, cardiovascular death, systemic embolic events at 6 months, 12 months;Safety endpoints: procedure-related ischaemic and hemorrhagic stroke, pericardial effusion, death; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events at 12 months and 24 months; | — |
Countries
China
Contacts
Public ContactChan Hoi Man
research nurse, Division of Cardiology, Department of Medicine & Therapeutics, PWH
Outcome results
None listed