Background Cardiac Resynchronization Therapy (CRT) is proven to improve survival and heart function of patient with certain electrical conduction abnormality and heart failure. However, in patient with certain electrical conduction abnormality, being nonresponder is observed in up to 40% in patient receiving CRT. Conventionally the surgical approach of CRT is to implant one pacing lead in the right heart and one in the left heart to resynchronize the contraction and the pacing lead in the left heart is usually placed in the posterior or lateral portion of the left heart. However, this single approach may not be optimal, especially for those patients with conduction abnormality known to have no response to CRT. Purpose of the clinical investigation The purpose of the Activation Pattern and Acute Hemodynamics of His and Left Bundle Pacing is to study the acute effect on the heart function and conduction abnormality of His and left bundle pacing in conventional CRT candidate. During CRT implantation, Hisbundle lead and Left bundle pacing lead will be placed and the acute effect on heart function will be studied by a wire placed in the left ventricle of the heart and the activation pattern will be studied by a noninvasive global mapping system. The pacing approach that optimally corrects conduction abnormality and improvement on the heart function acutely will be determined
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
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
RECRUITINGImprovement in myocardiac activation
Correction of activation abnormality as evaluated by global noninvasive mapping system (ECGi) seen as an increase in acute dp/dt \> 5% from baseline with left bundle pacing comparing to biventricular pacing.
Time frame: 6 months
Procedure duration
Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.
Time frame: during procedure
Implantation success rate
Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.
Time frame: during procedure
Cine images and chest X ray
Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view) obtained during course of study for assessment of disease
Time frame: 6 months
Echocardiogram parameters: strain imaging
Echocardiogram parameters: strain imaging at baseline, 3 months and 6 months
Time frame: 6 months
Echocardiogram parameters: left ventricular systolic and diastolic volume
Echocardiogram parameters: left ventricular systolic and diastolic volume at baseline, 3 months and 6 months
Time frame: 6 months
Echocardiogram parameters: left ventricular ejection fraction
Echocardiogram parameters: left ventricular ejection fraction at baseline, 3 months and 6 months
Time frame: 6 months
Echocardiogram parameters: degree of mitral regurgitation
Echocardiogram parameters at baseline, 3 months and 6 months
Time frame: 6 months
Change in New York Heart Association class
Comparison of NYHA class at baseline, 3 months and 6 months to assess changes in quality of life of subject.
Time frame: 6 months
Device parameter: defibrillation threshold
Electrical parameters including defibrillation threshold at implant and 6 months follow-up.
Time frame: 6 months
post-operative 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 parameter: defibrillation sensitivity
Electrical parameters including defibrillation sensitivity at implant and 6 months follow-up.
Time frame: 6 months
Device parameter: lead impedance
Electrical parameters including lead impedance of pacing leads at addition of new lead and 6 months follow-up.
Time frame: 6 months
Change in 6 minute hall walk test result
Comparison of 6 minute hall walk test result at baseline, 3 months and 6 months to assess changes in quality of life of subject.
Time frame: 6 months
Change in HF Patient Global Assessment Questionnaire outcome
Comparison of HF Patient Global Assessment Questionnaire outcome at baseline, 3 months and 6 months to assess changes in quality of life of subject.
Time frame: 6 months
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