Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00034

2 Trial Registration Date

2005-09-07

i Registration Status

Retrospective

3 Secondary IDs

None

4 Source(s) of Funding

NIL

5 Primary Sponsor

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Dr. Fung Wing Hong

ii Address

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

iii Phone

852-2683-8525

iv Email

jwhfung@cuhk.edu.hk

v Affiliation

PWH

vi Country

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

i Name

Dr. Fung Wing Hong

ii Address

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

iii Phone

852-2683-8525

iv Email

jwhfung@cuhk.edu.hk

v Affiliation

PWH

vi Country

9 Official Scientific Title of the Study

Effect of atrioventricular nodal ablation on left ventricular systolic function in patients with atrial fibrillation already received cardiac resynchronization therapy

10 Public Title

Effect of atrioventricular nodal ablation on left ventricular systolic function in patients with atrial fibrillation already received cardiac resynchronization therapy

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

N/A

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?

2005-04-06

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Heart and Blood Vessel Diseases

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

atrioventricular nodal ablation

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

once

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

Inclusion:Patients with atrial fibrillation and already received CRT device

ii Exclusion Criteria

Exclusion: Patients with recent myocardial infarction, acute coronary syndrome, unstable medical condtions and life expectancy less than 6 months

iii Age Minimum

>18

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

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

2005-05-09

21 Target Sample Size

20

22 Recruitment Status

Complete

23 Primary Outcome

Provide a better rate control profile for those patients in AF who had already received CRT

24 Secondary Outcome

Further improve the cardiac function in those patients

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-23

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000632

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2011-02-08