Clinical trial NCT05555966: CardioInsight 1 RBBB
Official title: Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Left Ventricle (LV) end systolic volume reduction
timeFrame: 6 months
Secondary outcomes:
measure: Electrical dyssynchrony index
timeFrame: During procedure
measure: Hemodynamic response monitoring
timeFrame: During procedure
measure: Procedure outcome with optimal CRT delivery
timeFrame: During procedure
measure: Cine images and chest X ray
timeFrame: 6 months
measure: Echocardiogram parameter: left ventricular systolic and diastolic volume
timeFrame: 6 months
measure: Multi-dimensional Quality of life changes
timeFrame: 6 months
measure: Device set-up parameter :defibrillation threshold
timeFrame: 6 months
measure: Post-operation Complication rate
timeFrame: 6 months
measure: Device set-up parameter :defibrillation sensitivity
timeFrame: 6 months
measure: Device set-up parameter: lead impedance of pacing leads
timeFrame: 6 months
measure: Change in 6 minute hall walk test
timeFrame: 6 months
measure: Change in HF Patient Global Assessment Questionnaire
timeFrame: 6 months
measure: Change in quality of life
timeFrame: 6 months
measure: Implantation success rate with optimal CRT delivery
timeFrame: During procedure
measure: Echocardiogram parameter: left ventricular ejection fraction
timeFrame: 6 months
measure: Echocardiogram parameter: degree of mitral regurgitation
timeFrame: 6 months
measure: Echocardiogram parameter: strain imaging
timeFrame: 6 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Bryan Yan
role: PRINCIPAL_INVESTIGATOR
References: