CardioInsight 3 - LBBB

NCT05556018 | Recruiting

• 1 other identifier: 2019.021-T
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Procedure duration

  during procedure

• Implantation success rate

  during procedure

• Cine images and chest X ray

  6 months

• Echocardiogram parameters: strain imaging

  6 months

• Echocardiogram parameters: left ventricular systolic and diastolic volume

  6 months

Study Arms (1)

Tailor-made CRT delivery

EXPERIMENTAL

Cardiac resynchronization therapy given according to Electrical Activation Mapping result

Device: Electrical Activation Mapping Guided Cardiac resynchronization therapy

Interventions

Electrical Activation Mapping Guided Cardiac resynchronization therapy DEVICE

To study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation

Tailor-made CRT delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• Participating in another study

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, 999077, Hong Kong

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bryan Yan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Xu

CONTACT

35051518; danielxu@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 27, 2022
• Study Start: July 5, 2019
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

HK (1)