CardioInsight 2 - Non-responder (CardioInsight2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Electrical Activation Mapping Guided Cardiac resynchronization therapy

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Xu; Phone Number: 1518 35051518; Email: danielxu@cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong, 999077
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Daniel Xu; Phone Number: 1518 35051518; Email: danielxu@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrical desynchrony index	The acute electrical desynchrony indices (the standard deviation of activation times throughout the epicardium) of different methods of CRT delivery. Lower indicate larger improvement.	During procedure
Hemodynamic response monitoring	Monitor the difference in hemodynamic responses of different methods of CRT delivery. The hemodynamic response will be maximal dp/dt as measured by pressure wire introduced into the left ventricle during the procedure.	During procedure
Procedure duration of different methods of CRT delivery	Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.	During procedure
Implantation success rate of different methods of CRT delivery	Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.	During procedure
Cine images and chest X ray	Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view) of patients will be obtained for evaluation of changes in disease	6 months
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
Echocardiogram parameters: left ventricular ejection fraction	Echocardiogram parameters: left ventricular ejection fraction at baseline, 3 months and 6 months	6 months
Echocardiogram parameters: degree of mitral regurgitation	Echocardiogram parameter: degree of mitral regurgitation at baseline, 3 months and 6 months.	6 months
Echocardiogram parameters: strain imaging	Echocardiogram parameters: strain imaging at baseline, 3 months and 6 months	6 months
Change in New York Heart Association (NYHA) class	Overall changes in QoL measured by change in NYHA class at baseline, 3 months and 6 months.	6 months
Device set-up parameter: defibrillation threshold	Device parameters including defibrillation threshold at implant and 6 months follow-up.	6 months
Post-operation 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
Change in 6 minute hall walk test	Compare result of 6 minute hall walk test at baseline, 3 months and 6 months.	6 months
Change in HF Patient Global Assessment Questionnaire	Compare result of HF Patient Global Assessment Questionnaire at baseline, 3 months and 6 months.	6 months
Change in quality of life	Change in quality of life assessed by Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months.	6 months
Device set-up parameter: defibrillation sensitivity	Device parameters including defibrillation sensitivity at implant and 6 months follow-up.	6 months
Device set-up parameter: lead impedance	Device parameters including lead impedance of pacing leads at implant and 6 months follow-up.	6 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Byran Yan, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2018.215

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No