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Trial History Detail on 2014-02-23

CUHK_CCT00351

2013-01-22

Prospective

Nil

SK Yee Funding, CUHK

SK Yee Funding, CUHK

Nil

Chan Hoi Man

124010A, 10/F, Clinical Science Building, Prince of Wales Hospital

2632 3717

jackiehmc@cuhk.edu.jk

research nurse, Division of Cardiology, Department of Medicine & Therapeutics, PWH

Chan Hoi Man

124010A, 10/F, Clinical Science Building, Prince of Wales Hospital

2632 3717

jackiehmc@cuhk.edu.hk

research nurse, Division of Cardiology, Department of Medicine & Therapeutics, PWH

Percutaneous Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

Percutaneous Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

經皮封堵左心耳手術預防由心房纖維性顫動導致的中風

Percutaneous LAA Closure Registry

Hong Kong

Yes

2013-01-03

Atrial Fibrillation

Device

Left Atrial Appendage (LAA) occlude: Watchman or ACP device

life long

Nil

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

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

18

Nil

Both Male and Female

Interventional

Non-randomized

Not Applicable

Open label

Single group

2013-02-28

80

Unknown

1. Efficacy endpoints: stroke, cardiovascular death, systemic embolic events at 6 months, 12 months, & 24 months
2. Safety endpoints: procedure-related ischaemic and hemorrhagic stroke, pericardial effusion, death, hemorrhage, device embolization, thrombus on device, any intra-procedural adverse events at Day 1, 45 days, 6 months, 12 months, & 24 months

Adverse events at 12 months and 24 months

No

2014-02-23

ChiCTR-ONC-13003015

2013-01-22


Yes

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