Clinical trial NCT05555992: CardioInsight 2 - Non-responder
Official title: Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy for Non-responder
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: 18
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: 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 Electrical Activation Guided CRT for Nonresponders Study is to study the effectiveness of an addition of Hisbundle pacing approach to CRT nonresponder by direct His-bundle pacing to improve the responder rate of nonresponder of conventional CRT and a tailored made approach to CRT procedure by using a noninvasive globally mapping system studying the electrical conduction under different approaches to delivery CRT. The pacing approach that optimally corrects conduction abnormality will be determined before the actual addition of new lead procedure.

Conduct of the Investigation This study will include 18 patients already implanted with device delivering conventional CRT that known to have no response to the conventional CRT after 6 months of the CRT therapy from Prince of Wales Hospital, Hong Kong. You will be followed in the device clinic as per usual care after your participation in the study is completed.


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 -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 end systolic volume reduction
timeFrame: 6 months
Secondary outcomes:
measure: Electrical desynchrony index
timeFrame: During procedure
measure: Hemodynamic response monitoring
timeFrame: During procedure
measure: Procedure duration of different methods of CRT delivery
timeFrame: During procedure
measure: Implantation success rate of different methods of CRT delivery
timeFrame: During procedure
measure: Cine images and chest X ray
timeFrame: 6 months
measure: Echocardiogram parameters: left ventricular systolic and diastolic volume
timeFrame: 6 months
measure: Echocardiogram parameters: left ventricular ejection fraction
timeFrame: 6 months
measure: Echocardiogram parameters: degree of mitral regurgitation
timeFrame: 6 months
measure: Echocardiogram parameters: strain imaging
timeFrame: 6 months
measure: Change in New York Heart Association (NYHA) class
timeFrame: 6 months
measure: Device set-up parameter: defibrillation threshold
timeFrame: 6 months
measure: Post-operation Complication rate
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: Device set-up parameter: defibrillation sensitivity
timeFrame: 6 months
measure: Device set-up parameter: lead impedance
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: Byran Yan
role: PRINCIPAL_INVESTIGATOR
References: