CardioInsight 2 - Non-responder

NCT05555992 | Unknown

• 1 other identifier: 2018.215
• Study Type: interventional
• Target: 18
• 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 Electrical Activation Guided CRT for Nonresponders Study is to study the effectiveness of an addition of Hisbundle pacing approach to CRT nonresponder by direct His-bundle pacing to improve the responder rate of nonresponder of conventional CRT and a tailored made approach to CRT procedure by using a noninvasive globally mapping system studying the electrical conduction under different approaches to delivery CRT. The pacing approach that optimally corrects conduction abnormality will be determined before the actual addition of new lead procedure. Conduct of the Investigation This study will include 18 patients already implanted with device delivering conventional CRT that known to have no response to the conventional CRT after 6 months of the CRT therapy from Prince of Wales Hospital, Hong Kong. You will be followed in the device clinic as per usual care after your participation in the study is completed.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Left Ventricle end systolic volume reduction

  The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram.

  6 months

Secondary Outcomes (17)

• Electrical desynchrony index

  During procedure

• Hemodynamic response monitoring

  During procedure

• Procedure duration of different methods of CRT delivery

  During procedure

• Implantation success rate of different methods of CRT delivery

  During procedure

• Cine images and chest X ray

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

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

Treatment

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
• Ischemic or non-ischemic cause of heart failure
• QRS duration \> 120 ms, non -LBBB type of conduction disturbance
• NYHA class III or above
• Informed consent by the patient
• Already received stable dose of guideline directed medical therapy for at least 3 months

You may not qualify if:

• LBBB patients
• Pregnant women
• Participation in another study
• Patient with contraindication to left ventricle catheterization by a retrograde aortic approach

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

• Byran 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 15, 2022
• First Posted: September 27, 2022
• Study Start: January 2, 2020
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

HK (1)