Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00351

2 Trial Registration Date

2013-01-22

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

SK Yee Funding, CUHK

5 Primary Sponsor

SK Yee Funding, CUHK

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Chan Hoi Man

ii Address

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

iii Phone

2632 3717

iv Email

jackiehmc@cuhk.edu.jk

v Affiliation

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

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Chan Hoi Man

ii Address

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

iii Phone

2632 3717

iv Email

jackiehmc@cuhk.edu.hk

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

Percutaneous Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

10 Public Title

Percutaneous Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

i Public Title in Chinese 研究名稱

經皮封堵左心耳手術預防由心房纖維性顫動導致的中風

11 Short Title (Optional)

Percutaneous LAA Closure Registry

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-01-03

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Atrial Fibrillation

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

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

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

life long

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i 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

ii 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

iii Age Minimum

18

iv Age Maximum

Nil

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-02-28

21 Target Sample Size

80

22 Recruitment Status

Unknown

23 Primary Outcome

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

24 Secondary Outcome

Adverse events at 12 months and 24 months

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-02-23

27 Primary Registry and Trial Identifying Number

ChiCTR-ONC-13003015

28 Date of Registration in Primary Registry

2013-01-22

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2014-02-23