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CardioInsight 3 - LBBB (CardioInsight3)

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
  • Candidate for CRT therapy according to international guidelines.7
  • Informed consent by the patient
  • Already received stable dose of guideline directed medical therapy for at least 3 months

Exclusion Criteria:

  • Pregnant
  • Participating in another study

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

Cardiac resynchronization therapy given according to Electrical Activation Mapping result

Outcomes

Primary Outcome Measures

Improvement in myocardiac activation
Correction of activation abnormality as evaluated by global noninvasive mapping system (ECGi) seen as an increase in acute dp/dt > 5% from baseline with left bundle pacing comparing to biventricular pacing.

Secondary Outcome Measures

Procedure duration
Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.
Implantation success rate
Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.
Cine images and chest X ray
Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view) obtained during course of study for assessment of disease
Echocardiogram parameters: strain imaging
Echocardiogram parameters: strain imaging at baseline, 3 months and 6 months
Echocardiogram parameters: left ventricular systolic and diastolic volume
Echocardiogram parameters: left ventricular systolic and diastolic volume at baseline, 3 months and 6 months
Echocardiogram parameters: left ventricular ejection fraction
Echocardiogram parameters: left ventricular ejection fraction at baseline, 3 months and 6 months
Echocardiogram parameters: degree of mitral regurgitation
Echocardiogram parameters at baseline, 3 months and 6 months
Change in New York Heart Association class
Comparison of NYHA class at baseline, 3 months and 6 months to assess changes in quality of life of subject.
Device parameter: defibrillation threshold
Electrical parameters including defibrillation threshold at implant and 6 months follow-up.
post-operative complication rate
Peri-operative and 6 months follow-up complications rate: Thromboembolic event Dislodgement and migration of pacing leads Phrenic nerve stimulation Others
Device parameter: defibrillation sensitivity
Electrical parameters including defibrillation sensitivity at implant and 6 months follow-up.
Device parameter: lead impedance
Electrical parameters including lead impedance of pacing leads at addition of new lead and 6 months follow-up.
Change in 6 minute hall walk test result
Comparison of 6 minute hall walk test result at baseline, 3 months and 6 months to assess changes in quality of life of subject.
Change in HF Patient Global Assessment Questionnaire outcome
Comparison of HF Patient Global Assessment Questionnaire outcome at baseline, 3 months and 6 months to assess changes in quality of life of subject.

Full Information

First Posted
September 16, 2022
Last Updated
September 22, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05556018
Brief Title
CardioInsight 3 - LBBB
Acronym
CardioInsight3
Official Title
Activation Pattern and Acute Hemodynamics of His and Left Bundle Pacing
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 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
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 Activation Pattern and Acute Hemodynamics of His and Left Bundle Pacing is to study the acute effect on the heart function and conduction abnormality of His and left bundle pacing in conventional CRT candidate. During CRT implantation, Hisbundle lead and Left bundle pacing lead will be placed and the acute effect on heart function will be studied by a wire placed in the left ventricle of the heart and the activation pattern will be studied by a noninvasive global mapping system. The pacing approach that optimally corrects conduction abnormality and improvement on the heart function acutely will be determined

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
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tailor-made CRT delivery
Arm Type
Experimental
Arm Description
Cardiac resynchronization therapy given according to 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
Improvement in myocardiac activation
Description
Correction of activation abnormality as evaluated by global noninvasive mapping system (ECGi) seen as an increase in acute dp/dt > 5% from baseline with left bundle pacing comparing to biventricular pacing.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Procedure duration
Description
Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.
Time Frame
during procedure
Title
Implantation success rate
Description
Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony 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) obtained during course of study for assessment of disease
Time Frame
6 months
Title
Echocardiogram parameters: strain imaging
Description
Echocardiogram parameters: strain imaging at baseline, 3 months and 6 months
Time Frame
6 months
Title
Echocardiogram parameters: left ventricular systolic and diastolic volume
Description
Echocardiogram parameters: left ventricular systolic and diastolic volume at baseline, 3 months and 6 months
Time Frame
6 months
Title
Echocardiogram parameters: left ventricular ejection fraction
Description
Echocardiogram parameters: left ventricular ejection fraction at baseline, 3 months and 6 months
Time Frame
6 months
Title
Echocardiogram parameters: degree of mitral regurgitation
Description
Echocardiogram parameters at baseline, 3 months and 6 months
Time Frame
6 months
Title
Change in New York Heart Association class
Description
Comparison of NYHA class at baseline, 3 months and 6 months to assess changes in quality of life of subject.
Time Frame
6 months
Title
Device parameter: defibrillation threshold
Description
Electrical parameters including defibrillation threshold at implant and 6 months follow-up.
Time Frame
6 months
Title
post-operative 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 parameter: defibrillation sensitivity
Description
Electrical parameters including defibrillation sensitivity at implant and 6 months follow-up.
Time Frame
6 months
Title
Device parameter: lead impedance
Description
Electrical parameters including lead impedance of pacing leads at addition of new lead and 6 months follow-up.
Time Frame
6 months
Title
Change in 6 minute hall walk test result
Description
Comparison of 6 minute hall walk test result at baseline, 3 months and 6 months to assess changes in quality of life of subject.
Time Frame
6 months
Title
Change in HF Patient Global Assessment Questionnaire outcome
Description
Comparison of HF Patient Global Assessment Questionnaire outcome at baseline, 3 months and 6 months to assess changes in quality of life of subject.
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 Candidate for CRT therapy according to international guidelines.7 Informed consent by the patient Already received stable dose of guideline directed medical therapy for at least 3 months Exclusion Criteria: Pregnant Participating in another study
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 3 - LBBB

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