Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00092

2 Trial Registration Date

2005-12-07

i Registration Status

Prospective

3 Secondary IDs

4 Source(s) of Funding

HK-IN-PACE

5 Primary Sponsor

Medtronic

6 Secondary Sponsor

Function

Please specify

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

i Name

Dr. Wing hong FUNG

ii Address

iii Phone

HK-OPT Study

iv Email

Tel.

v Affiliation

vi Country

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

i Name

Dr. Wing hong FUNG

ii Address

iii Phone

HK-OPT Study

iv Email

Tel.

v Affiliation

vi Country

9 Official Scientific Title of the Study

Hong Kong Optimal Pacing to Preserve Left Ventricular Function Study

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

HK-OPT Study

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2005-09-26

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

Device

Please specify

ii Description/ name of Intervention/article

Hong KOng Optimal Pacing to Preserve Left Ventricular Function

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

48 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

MVP ON and OFF

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 Criteria - Patient has symptomatic sinus node disease and QRS duration < 120ms and LV ejection fraction more than or equal to 45% by transthoracic echocardiography with standard pacing indication according to the current ACC/AHA/NASPE guidelines - Patient has signed and dated study informed consent - Patient is able to receive pectoral implant - Patient will likely remain on a stable cardiac drug regimen, including anti-arrhythmic agents throughout the 12-month follow-up period. Exclusion Criteria - Patient has co-existing second degree or complete heart block - Patient has mechanical right heart valve - Patients with permanent atrial fibrillation (AF) - Patient is under a minimum age as defined by local law - Patient is enrolled in any concurrent study that would confound the results of this study - Patient has a life expectancy of less than 12 months - Women who are pregnant, or with child-bearing potential and who are not on a form of birth control - Patient has had a heart transplant

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Historical control

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-12-10

21 Target Sample Size

200

22 Recruitment Status

Recruiting

23 Primary Outcome

- Left Ventricular End Systolic Volume (LVESV)* at 12 months - Ejection Fraction * at 12 months

24 Secondary Outcome

- Tissue Dopplor Imaging (TDI) - Incidence of AF at 36 months - Heart Failure Hospitalization at 36 months - Mitral Valve Regurgitation Index* at 12 months - E/A ratio * at 12 months - SF-36® Health Survey Questionnaire at 36 months - BNP, ANP, N-terminal pro-BNP, epinephrine and norepinephrine levels (* by 2D echo)

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

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2005-12-07