CardioInsight 3 - LBBB (CardioInsight3)

Activation Pattern and Acute Hemodynamics of His and Left Bundle Pacing

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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Electrical Activation Mapping Guided Cardiac resynchronization therapy

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Xu; Phone Number: 35051518; Email: danielxu@cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong, 999077
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Daniel Xu; Phone Number: 1518 35051518; Email: danielxu@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailor-made CRT delivery; Cardiac resynchronization therapy given according to Electrical Activation Mapping result	Device: Electrical Activation Mapping Guided Cardiac resynchronization therapy; To study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiogram parameters: left ventricular ejection fraction	Echocardiogram parameters: left ventricular ejection fraction at baseline, 3 months and 6 months	6 months
Echocardiogram parameters: strain imaging	Echocardiogram parameters: strain imaging at baseline, 3 months and 6 months	6 months
Procedure duration	Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.	during procedure
Implantation success rate	Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.	during procedure
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	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	6 months
Echocardiogram parameters: degree of mitral regurgitation	Echocardiogram parameters at baseline, 3 months and 6 months	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.	6 months
Device parameter: defibrillation threshold	Electrical parameters including defibrillation threshold at implant and 6 months follow-up.	6 months
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	6 months
Device parameter: defibrillation sensitivity	Electrical parameters including defibrillation sensitivity at implant and 6 months follow-up.	6 months
Device parameter: lead impedance	Electrical parameters including lead impedance of pacing leads at addition of new lead and 6 months follow-up.	6 months
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.	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Bryan Yan, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2019.021-T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No