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Trial History Detail on 2012-12-28

CUHK_CCT00037

2005-09-08

Retrospective

Nil

Medtronic

Prof. Cheuk-Man Yu

Nil

Prof. Cheuk-Man Yu

Rm.12A28, 12/F, main building, PWH

Tel 2632 1752

cmyu@cuhk.edu.hk/poonsp@cuhk.edu.hk

Nil

Prof. Cheuk-Man Yu

Rm.12A28, 12/F, main building, PWH

Tel 2632 1752

cmyu@cuhk.edu.hk/poonsp@cuhk.edu.hk

Nil

Pacing to Avoid Cardiac Enlargement Study

Pacing to Avoid Cardiac

PACE study

Hong Kong

Yes

2004-03-22

Heart and Blood Vessel Diseases

Device

Right ventricular apical (PVA) pacing or Biventricular pacing

3 years

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.

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.

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.

> 18 years of age

> 18 years of age

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2005-03-31

177

Complete

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

N/A

No

2014-01-29

ChiCTR-TRC-09000635

2010-05-04


Yes

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