CardioInsight 1 RBBB
CardioInsight1
Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy
1 other identifier
interventional
93
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Sep 2017
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 15, 2022
CompletedFirst Posted
Study publicly available on registry
September 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedSeptember 27, 2022
September 1, 2022
7 years
September 15, 2022
September 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Left Ventricle (LV) end systolic volume reduction
The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram
6 months
Secondary Outcomes (17)
Electrical dyssynchrony index
During procedure
Hemodynamic response monitoring
During procedure
Procedure outcome with optimal CRT delivery
During procedure
Cine images and chest X ray
6 months
Echocardiogram parameter: left ventricular systolic and diastolic volume
6 months
- +12 more secondary outcomes
Study Arms (1)
Tailor-made CRT delivery
EXPERIMENTALDevice placement based on Electrical Activation Mapping result
Interventions
To study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- LBBB patients
- Pregnant women
- Participation in another study
- Patient with contraindication to left ventricle catheterization by a retrograde aortic approach
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Chinese University of Hong Kong
Shatin, 999077, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bryan Yan
Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 15, 2022
First Posted
September 27, 2022
Study Start
September 1, 2017
Primary Completion
August 31, 2024
Study Completion
December 31, 2024
Last Updated
September 27, 2022
Record last verified: 2022-09