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Clinical Trials/NCT05555992
NCT05555992
Recruiting
N/A

Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy for Non-responder

Chinese University of Hong Kong1 site in 1 country18 target enrollmentJanuary 2, 2020
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Chinese University of Hong Kong
Enrollment
18
Locations
1
Primary Endpoint
Left Ventricle end systolic volume reduction
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2020
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Professor Bryan Ping Yen YAN

Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Left Ventricle end systolic volume reduction

Time Frame: 6 months

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

Secondary Outcomes

  • Hemodynamic response monitoring(During procedure)
  • Cine images and chest X ray(6 months)
  • Echocardiogram parameters: left ventricular systolic and diastolic volume(6 months)
  • Device set-up parameter: defibrillation threshold(6 months)
  • Change in quality of life(6 months)
  • Procedure duration of different methods of CRT delivery(During procedure)
  • Electrical desynchrony index(During procedure)
  • Change in 6 minute hall walk test(6 months)
  • Device set-up parameter: lead impedance(6 months)
  • Implantation success rate of different methods of CRT delivery(During procedure)
  • Device set-up parameter: defibrillation sensitivity(6 months)
  • Echocardiogram parameters: degree of mitral regurgitation(6 months)
  • Post-operation Complication rate(6 months)
  • Echocardiogram parameters: left ventricular ejection fraction(6 months)
  • Echocardiogram parameters: strain imaging(6 months)
  • Change in New York Heart Association (NYHA) class(6 months)
  • Change in HF Patient Global Assessment Questionnaire(6 months)

Study Sites (1)

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