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Trial History Detail on 2005-12-07

CUHK_CCT00092

2005-12-07

Prospective

HK-IN-PACE

Medtronic

Dr. Wing hong FUNG

HK-OPT Study

Tel.

Dr. Wing hong FUNG

HK-OPT Study

Tel.

Hong Kong Optimal Pacing to Preserve Left Ventricular Function Study

HK-OPT Study

Yes

2005-09-26

Heart and Blood Vessel Diseases

Device

Hong KOng Optimal Pacing to Preserve Left Ventricular Function

48 months

MVP ON and OFF

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

Randomized

Historical control

Double-blind

Parallel

2005-12-10

200

Recruiting

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

- 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)

No

2009-11-23


Yes

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