CardioInsight 3 - LBBB

Heart Failure Clinical Trial

— CardioInsight3  

Official title:

Activation Pattern and Acute Hemodynamics of His and Left Bundle Pacing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556018
• Other study ID #: 2019.021-T
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: Daniel Xu
• Phone: 35051518
• Email: danielxu[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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