Cardiac resynchronization therapy (CRT) is an established therapy for symptomatic heart failure patients. However, there are still 30 to 40% of studied patients being nonresponder to CRT. The plausible reasons of lack of effect of CRT in these patients include relative less baseline electrical dyssynchrony. The aim of our study is to investigate whether there is an optimal configuration of CRT delivery that varies between patients with different pattern of activation delay.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
93
To study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation
The Chinese University of Hong Kong
Shatin, Hong Kong
RECRUITINGLeft Ventricle (LV) end systolic volume reduction
The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram
Time frame: 6 months
Electrical dyssynchrony index
The acute electrical dyssynchrony indices (the standard deviation of activation times throughout the epicardium) of different methods of CRT delivery. Lower indicate larger improvement.
Time frame: During procedure
Hemodynamic response monitoring
monitor the difference in hemodynamic responses of different methods of CRT delivery method. The hemodynamic response will be maximal dp/dt as measured by pressure wire introduced into the left ventricle during the procedure.
Time frame: During procedure
Procedure outcome with optimal CRT delivery
Procedure outcome measured by procedure duration and implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
Time frame: During procedure
Cine images and chest X ray
Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view) of patients will be obtained for evaluation of changes in disease
Time frame: 6 months
Echocardiogram parameter: left ventricular systolic and diastolic volume
left ventricular systolic and diastolic volume at baseline, 3 months and 6 months : , left ventricular ejection fraction, degree of mitral regurgitation, strain imaging will be aggregated to arrive at an overall change in echocardiogram parameters as together they represent integrated heart function collectively, as reflected by the listed echocardiogram parameters.
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Time frame: 6 months
Multi-dimensional Quality of life changes
change in New York Heart Association (NYHA) class, 6 minute hall walk test, HF Patient Global Assessment Questionnaire and quality of life using Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months.
Time frame: 6 months
Device set-up parameter :defibrillation threshold
Device parameters including defibrillation threshold at implant and 6 months follow-up.
Time frame: 6 months
Post-operation Complication rate
Peri-operative and 6 months follow-up complications rate: 1. Thromboembolic event 2. Dislodgement and migration of pacing leads 3. Phrenic nerve stimulation 4. Others
Time frame: 6 months
Device set-up parameter :defibrillation sensitivity
Device set-up parameter :defibrillation sensitivity at implant and 6 months follow-up
Time frame: 6 months
Device set-up parameter: lead impedance of pacing leads
Device set-up parameter: lead impedance of pacing leads at implant and 6 months follow-up
Time frame: 6 months
Change in 6 minute hall walk test
Change in 6 minute hall walk test result, at baseline, 3 months and 6 months.
Time frame: 6 months
Change in HF Patient Global Assessment Questionnaire
HF Patient Global Assessment Questionnaire at baseline, 3 months and 6 months.
Time frame: 6 months
Change in quality of life
Change in quality of life assessed by Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months.
Time frame: 6 months
Implantation success rate with optimal CRT delivery
Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
Time frame: During procedure
Echocardiogram parameter: left ventricular ejection fraction
Echocardiogram parameter: left ventricular ejection fraction at baseline, 3 months and 6 months
Time frame: 6 months
Echocardiogram parameter: degree of mitral regurgitation
Echocardiogram parameter: degree of mitral regurgitation at baseline, 3 months and 6 months
Time frame: 6 months
Echocardiogram parameter: strain imaging
Echocardiogram parameter: strain imaging at baseline, 3 months and 6 months
Time frame: 6 months