Activation Pattern and Acute Hemodynamics of His and Left Bundle Pacing
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Improvement in myocardiac activation
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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
Investigators
Professor Bryan Ping Yen YAN
Professor
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •Adult (aged 18 or above) of both sexes
- •Candidate for CRT therapy according to international guidelines.7
- •Informed consent by the patient
- •Already received stable dose of guideline directed medical therapy for at least 3 months
Exclusion Criteria
- •Participating in another study
Outcomes
Primary Outcomes
Improvement in myocardiac activation
Time Frame: 6 months
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.
Secondary Outcomes
- Implantation success rate(during procedure)
- Echocardiogram parameters: degree of mitral regurgitation(6 months)
- Change in New York Heart Association class(6 months)
- Cine images and chest X ray(6 months)
- Echocardiogram parameters: strain imaging(6 months)
- Echocardiogram parameters: left ventricular systolic and diastolic volume(6 months)
- Procedure duration(during procedure)
- Device parameter: lead impedance(6 months)
- Echocardiogram parameters: left ventricular ejection fraction(6 months)
- post-operative complication rate(6 months)
- Device parameter: defibrillation sensitivity(6 months)
- Change in 6 minute hall walk test result(6 months)
- Device parameter: defibrillation threshold(6 months)
- Change in HF Patient Global Assessment Questionnaire outcome(6 months)