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CardioInsight 1 RBBB (CardioInsight1)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Electrical Activation Mapping Guided Cardiac resynchronization therapy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tailor-made CRT delivery

Arm Description

Device placement based on Electrical Activation Mapping result

Outcomes

Primary Outcome Measures

Left Ventricle (LV) end systolic volume reduction
The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram

Secondary Outcome Measures

Electrical dyssynchrony index
The acute electrical dyssynchrony indices (the standard deviation of activation times throughout the epicardium) of different methods of CRT delivery. Lower indicate larger improvement.
Hemodynamic response monitoring
monitor the difference in hemodynamic responses of different methods of CRT delivery method. The hemodynamic response will be maximal dp/dt as measured by pressure wire introduced into the left ventricle during the procedure.
Procedure outcome with optimal CRT delivery
Procedure outcome measured by procedure duration and implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
Cine images and chest X ray
Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view) of patients will be obtained for evaluation of changes in disease
Echocardiogram parameter: left ventricular systolic and diastolic volume
left ventricular systolic and diastolic volume at baseline, 3 months and 6 months : , left ventricular ejection fraction, degree of mitral regurgitation, strain imaging will be aggregated to arrive at an overall change in echocardiogram parameters as together they represent integrated heart function collectively, as reflected by the listed echocardiogram parameters.
Multi-dimensional Quality of life changes
change in New York Heart Association (NYHA) class, 6 minute hall walk test, HF Patient Global Assessment Questionnaire and quality of life using Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months.
Device set-up parameter :defibrillation threshold
Device parameters including defibrillation threshold at implant and 6 months follow-up.
Post-operation Complication rate
Peri-operative and 6 months follow-up complications rate: Thromboembolic event Dislodgement and migration of pacing leads Phrenic nerve stimulation Others
Device set-up parameter :defibrillation sensitivity
Device set-up parameter :defibrillation sensitivity at implant and 6 months follow-up
Device set-up parameter: lead impedance of pacing leads
Device set-up parameter: lead impedance of pacing leads at implant and 6 months follow-up
Change in 6 minute hall walk test
Change in 6 minute hall walk test result, at baseline, 3 months and 6 months.
Change in HF Patient Global Assessment Questionnaire
HF Patient Global Assessment Questionnaire at baseline, 3 months and 6 months.
Change in quality of life
Change in quality of life assessed by Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months.
Implantation success rate with optimal CRT delivery
Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
Echocardiogram parameter: left ventricular ejection fraction
Echocardiogram parameter: left ventricular ejection fraction at baseline, 3 months and 6 months
Echocardiogram parameter: degree of mitral regurgitation
Echocardiogram parameter: degree of mitral regurgitation at baseline, 3 months and 6 months
Echocardiogram parameter: strain imaging
Echocardiogram parameter: strain imaging at baseline, 3 months and 6 months

Full Information

First Posted
September 15, 2022
Last Updated
September 22, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05555966
Brief Title
CardioInsight 1 RBBB
Acronym
CardioInsight1
Official Title
Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tailor-made CRT delivery
Arm Type
Experimental
Arm Description
Device placement based on Electrical Activation Mapping result
Intervention Type
Device
Intervention Name(s)
Electrical Activation Mapping Guided Cardiac resynchronization therapy
Intervention Description
To study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation
Primary Outcome Measure Information:
Title
Left Ventricle (LV) end systolic volume reduction
Description
The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Electrical dyssynchrony index
Description
The acute electrical dyssynchrony indices (the standard deviation of activation times throughout the epicardium) of different methods of CRT delivery. Lower indicate larger improvement.
Time Frame
During procedure
Title
Hemodynamic response monitoring
Description
monitor the difference in hemodynamic responses of different methods of CRT delivery method. The hemodynamic response will be maximal dp/dt as measured by pressure wire introduced into the left ventricle during the procedure.
Time Frame
During procedure
Title
Procedure outcome with optimal CRT delivery
Description
Procedure outcome measured by procedure duration and implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
Time Frame
During procedure
Title
Cine images and chest X ray
Description
Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view) of patients will be obtained for evaluation of changes in disease
Time Frame
6 months
Title
Echocardiogram parameter: left ventricular systolic and diastolic volume
Description
left ventricular systolic and diastolic volume at baseline, 3 months and 6 months : , left ventricular ejection fraction, degree of mitral regurgitation, strain imaging will be aggregated to arrive at an overall change in echocardiogram parameters as together they represent integrated heart function collectively, as reflected by the listed echocardiogram parameters.
Time Frame
6 months
Title
Multi-dimensional Quality of life changes
Description
change in New York Heart Association (NYHA) class, 6 minute hall walk test, HF Patient Global Assessment Questionnaire and quality of life using Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months.
Time Frame
6 months
Title
Device set-up parameter :defibrillation threshold
Description
Device parameters including defibrillation threshold at implant and 6 months follow-up.
Time Frame
6 months
Title
Post-operation Complication rate
Description
Peri-operative and 6 months follow-up complications rate: Thromboembolic event Dislodgement and migration of pacing leads Phrenic nerve stimulation Others
Time Frame
6 months
Title
Device set-up parameter :defibrillation sensitivity
Description
Device set-up parameter :defibrillation sensitivity at implant and 6 months follow-up
Time Frame
6 months
Title
Device set-up parameter: lead impedance of pacing leads
Description
Device set-up parameter: lead impedance of pacing leads at implant and 6 months follow-up
Time Frame
6 months
Title
Change in 6 minute hall walk test
Description
Change in 6 minute hall walk test result, at baseline, 3 months and 6 months.
Time Frame
6 months
Title
Change in HF Patient Global Assessment Questionnaire
Description
HF Patient Global Assessment Questionnaire at baseline, 3 months and 6 months.
Time Frame
6 months
Title
Change in quality of life
Description
Change in quality of life assessed by Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months.
Time Frame
6 months
Title
Implantation success rate with optimal CRT delivery
Description
Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
Time Frame
During procedure
Title
Echocardiogram parameter: left ventricular ejection fraction
Description
Echocardiogram parameter: left ventricular ejection fraction at baseline, 3 months and 6 months
Time Frame
6 months
Title
Echocardiogram parameter: degree of mitral regurgitation
Description
Echocardiogram parameter: degree of mitral regurgitation at baseline, 3 months and 6 months
Time Frame
6 months
Title
Echocardiogram parameter: strain imaging
Description
Echocardiogram parameter: strain imaging at baseline, 3 months and 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Xu
Phone
35051518
Email
danielxu@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Yan
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Shatin
ZIP/Postal Code
999077
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Xu
Phone
35051518
Ext
1518
Email
danielxu@cuhk.edu.hk

12. IPD Sharing Statement

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CardioInsight 1 RBBB

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