Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00037

2 Trial Registration Date

2005-09-08

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Medtronic

5 Primary Sponsor

Prof. Cheuk-Man Yu

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Prof. Cheuk-Man Yu

ii Address

iii Phone

Tel Tel 2632 3594

iv Email

v Affiliation

vi Country

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

i Name

Prof. Cheuk-Man Yu

ii Address

iii Phone

Tel Tel 2632 3594

iv Email

v Affiliation

vi Country

9 Official Scientific Title of the Study

Pacing to Avoid Cardiac Enlargement Study

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

PACE study

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-03-22

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

Right ventricular apical (PVA) pacing or Biventricular pacing

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

3 years

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

PACE Study aims to investigate the effect of pacing sites (Biventricular vs. Right ventricular apical) on left ventricular systolic and diastolic function in patients with normal LV systolic function and standard pacing indication.

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: 1.Patient > 18 years of age. 2. Patient has signed and dated study informed consent. 3. Patient is able to receive pectoral implant. 4. Patient with pacemaker indication. 5. patient has left ventricular ejection fraction >= 45%. 6. Patient will likely remain on a stable cardiac drug regimen, including antiarrhythmic agents throughout the 12 month follow-up period.

ii Exclusion Criteria

Exclusion: 1.Patient has mechanical right heart valve. 2. Patient is under the age of 18 or a minimum age as defined by local law. 3. Pastient has experienced unstable angina, acute myocardial infarction, CABG or PTCA within the past 3 months. 4. Patient with permanent atrial fibrillation. 5. Patient is enrolled in any concurrent study that would confound the results of this study. 6. Patient has a life expectancy of less than 6 months. 7. Women who are pregent, or with child-bearing potential and who are not on any form of birth control. 8. Patient has had a heart transplant.

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Single-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

2005-03-31

21 Target Sample Size

170

22 Recruitment Status

Recruiting

23 Primary Outcome

Biventricular pacing is better than RVA pacing in preserving LV function in patients with standard indication for pacing.

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-01-29

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

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Trial History Detail on 2009-11-19