CardioInsight 3 - LBBB

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Device: Electrical Activation Mapping Guided Cardiac resynchronization therapy

• Registration Number: NCT05556018
• Lead Sponsor: Chinese University of Hong Kong

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-05
• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Primary Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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

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Exclusion Criteria

• Pregnant
• Participating in another study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tailor-made CRT delivery	Electrical Activation Mapping Guided Cardiac resynchronization therapy	Cardiac resynchronization therapy given according to Electrical Activation Mapping result

Primary Outcome Measures

Name	Time	Method
Improvement in myocardiac activation	6 months	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

Name	Time	Method
Implantation success rate	during procedure	Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.
Echocardiogram parameters: degree of mitral regurgitation	6 months	Echocardiogram parameters at baseline, 3 months and 6 months
Change in New York Heart Association class	6 months	Comparison of NYHA class at baseline, 3 months and 6 months to assess changes in quality of life of subject.
Cine images and chest X ray	6 months	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	6 months	Echocardiogram parameters: strain imaging at baseline, 3 months and 6 months
Echocardiogram parameters: left ventricular systolic and diastolic volume	6 months	Echocardiogram parameters: left ventricular systolic and diastolic volume at baseline, 3 months and 6 months
Procedure duration	during procedure	Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.
Device parameter: lead impedance	6 months	Electrical parameters including lead impedance of pacing leads at addition of new lead and 6 months follow-up.
Echocardiogram parameters: left ventricular ejection fraction	6 months	Echocardiogram parameters: left ventricular ejection fraction at baseline, 3 months and 6 months
post-operative complication rate	6 months	Peri-operative and 6 months follow-up complications rate: 1. Thromboembolic event; 2. Dislodgement and migration of pacing leads; 3. Phrenic nerve stimulation; 4. Others
Device parameter: defibrillation sensitivity	6 months	Electrical parameters including defibrillation sensitivity at implant and 6 months follow-up.
Change in 6 minute hall walk test result	6 months	Comparison of 6 minute hall walk test result at baseline, 3 months and 6 months to assess changes in quality of life of subject.
Device parameter: defibrillation threshold	6 months	Electrical parameters including defibrillation threshold at implant and 6 months follow-up.
Change in HF Patient Global Assessment Questionnaire outcome	6 months	Comparison of HF Patient Global Assessment Questionnaire outcome at baseline, 3 months and 6 months to assess changes in quality of life of subject.

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong