CardioInsight 1 RBBB (CardioInsight1)

Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy

Cardiac resynchronization therapy (CRT) is an established therapy for symptomatic heart failure patients. However, there are still 30 to 40% of studied patients being nonresponder to CRT. The plausible reasons of lack of effect of CRT in these patients include relative less baseline electrical dyssynchrony. The aim of our study is to investigate whether there is an optimal configuration of CRT delivery that varies between patients with different pattern of activation delay.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 93
• Phase: Not Applicable

Contacts and Locations

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-left bundle branch block (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: Tailor-made CRT delivery; Device placement based on Electrical Activation Mapping result	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 (LV) 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
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
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 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
Electrical dyssynchrony index	The acute electrical dyssynchrony 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 method. The hemodynamic response will be maximal dp/dt as measured by pressure wire introduced into the left ventricle during the procedure.	During procedure
Procedure outcome with optimal CRT delivery	Procedure outcome measured by procedure duration and implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.	During procedure
Echocardiogram parameter: left ventricular systolic and diastolic volume	left ventricular systolic and diastolic volume at baseline, 3 months and 6 months : , left ventricular ejection fraction, degree of mitral regurgitation, strain imaging will be aggregated to arrive at an overall change in echocardiogram parameters as together they represent integrated heart function collectively, as reflected by the listed echocardiogram parameters.	6 months
Multi-dimensional Quality of life changes	change in New York Heart Association (NYHA) class, 6 minute hall walk test, HF Patient Global Assessment Questionnaire and quality of life using Minnesota's living with heart failure (MLWHF) questionnaire 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
Device set-up parameter :defibrillation sensitivity	Device set-up parameter :defibrillation sensitivity at implant and 6 months follow-up	6 months
Device set-up parameter: lead impedance of pacing leads	Device set-up parameter: lead impedance of pacing leads at implant and 6 months follow-up	6 months
Change in 6 minute hall walk test	Change in 6 minute hall walk test result, at baseline, 3 months and 6 months.	6 months
Change in HF Patient Global Assessment Questionnaire	HF Patient Global Assessment Questionnaire at baseline, 3 months and 6 months.	6 months
Implantation success rate with optimal CRT delivery	Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.	During procedure
Echocardiogram parameter: left ventricular ejection fraction	Echocardiogram parameter: left ventricular ejection fraction at baseline, 3 months and 6 months	6 months
Echocardiogram parameter: degree of mitral regurgitation	Echocardiogram parameter: degree of mitral regurgitation at baseline, 3 months and 6 months	6 months
Echocardiogram parameter: strain imaging	Echocardiogram parameter: strain imaging at baseline, 3 months and 6 months	6 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): December 31, 2024

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: 2017.316

Drug and device information, study documents

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