CUHK_CCT00092
2005-12-07
Prospective
None
HK-IN-PACE
Medtronic
N/A
Dr. Wing hong FUNG
HK-OPT Study
Tel.852-2683-8525
jwhfung@cuhk.edu.hk
PWH
Dr. Wing hong FUNG
HK-OPT Study
Tel.852-2683-8525
jwhfung@cuhk.edu.hk
PWH
Hong Kong Optimal Pacing to Preserve Left Ventricular Function Study
Hong Kong Optimal Pacing to Preserve Left Ventricular Function Study
HK-OPT Study
Hong Kong
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
>18
N/A
Both Male and Female
Observational
Randomized
Historical control
Double-blind
Parallel
2005-12-10
200
Complete
- 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)
2009-11-23
ChiCTR-TRC-09000673
2010-05-04
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