NCT05555966
Recruiting
Not Applicable
Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy
Chinese University of Hong Kong1 site in 1 country93 target enrollmentStarted: September 1, 2017Last updated:
ConditionsHeart Failure
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Left Ventricle (LV) end systolic volume reduction
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (aged 18 or above) of both sexes
- •Ischemic or non-ischemic cause of heart failure
- •QRS duration \> 120 ms, non-left bundle branch block (LBBB) type of conduction disturbance
- •NYHA class III or above
- •Informed consent by the patient
- •Already received stable dose of guideline directed medical therapy for at least 3 months
Exclusion Criteria
- •LBBB patients
- •Pregnant women
- •Participation in another study
- •Patient with contraindication to left ventricle catheterization by a retrograde aortic approach
Outcomes
Primary Outcomes
Left Ventricle (LV) end systolic volume reduction
Time Frame: 6 months
The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram
Secondary Outcomes
- Echocardiogram parameter: left ventricular systolic and diastolic volume(6 months)
- Hemodynamic response monitoring(During procedure)
- Cine images and chest X ray(6 months)
- Multi-dimensional Quality of life changes(6 months)
- Electrical dyssynchrony index(During procedure)
- Procedure outcome with optimal CRT delivery(During procedure)
- Device set-up parameter :defibrillation sensitivity(6 months)
- Change in 6 minute hall walk test(6 months)
- Implantation success rate with optimal CRT delivery(During procedure)
- Post-operation Complication rate(6 months)
- Echocardiogram parameter: strain imaging(6 months)
- Change in HF Patient Global Assessment Questionnaire(6 months)
- Device set-up parameter :defibrillation threshold(6 months)
- Device set-up parameter: lead impedance of pacing leads(6 months)
- Echocardiogram parameter: left ventricular ejection fraction(6 months)
- Echocardiogram parameter: degree of mitral regurgitation(6 months)
- Change in quality of life(6 months)
Investigators
Professor Bryan Ping Yen YAN
Professor
Chinese University of Hong Kong
Study Sites (1)
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