CardioInsight 1 RBBB

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Device: Electrical Activation Mapping Guided Cardiac resynchronization therapy

• Registration Number: NCT05555966
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-27
• Last Update Posted: 2022-09-27
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 93

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tailor-made CRT delivery	Electrical Activation Mapping Guided Cardiac resynchronization therapy	Device placement based on Electrical Activation Mapping result

Primary Outcome Measures

Name	Time	Method
Left Ventricle (LV) end systolic volume reduction	6 months	The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram

Secondary Outcome Measures

Name	Time	Method
Echocardiogram parameter: left ventricular systolic and diastolic volume	6 months	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.
Hemodynamic response monitoring	During procedure	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.
Cine images and chest X ray	6 months	Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view) of patients will be obtained for evaluation of changes in disease
Multi-dimensional Quality of life changes	6 months	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.
Electrical dyssynchrony index	During procedure	The acute electrical dyssynchrony indices (the standard deviation of activation times throughout the epicardium) of different methods of CRT delivery. Lower indicate larger improvement.
Procedure outcome with optimal CRT delivery	During procedure	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.
Device set-up parameter :defibrillation sensitivity	6 months	Device set-up parameter :defibrillation sensitivity at implant and 6 months follow-up
Change in 6 minute hall walk test	6 months	Change in 6 minute hall walk test result, at baseline, 3 months and 6 months.
Implantation success rate with optimal CRT delivery	During procedure	Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
Post-operation Complication rate	6 months	Peri-operative and 6 months follow-up complications rate: 1. Thromboembolic event; 2. Dislodgement and migration of pacing leads; 3. Phrenic nerve stimulation; 4. Others
Echocardiogram parameter: strain imaging	6 months	Echocardiogram parameter: strain imaging at baseline, 3 months and 6 months
Change in HF Patient Global Assessment Questionnaire	6 months	HF Patient Global Assessment Questionnaire at baseline, 3 months and 6 months.
Device set-up parameter :defibrillation threshold	6 months	Device parameters including defibrillation threshold at implant and 6 months follow-up.
Device set-up parameter: lead impedance of pacing leads	6 months	Device set-up parameter: lead impedance of pacing leads at implant and 6 months follow-up
Echocardiogram parameter: left ventricular ejection fraction	6 months	Echocardiogram parameter: left ventricular ejection fraction at baseline, 3 months and 6 months
Echocardiogram parameter: degree of mitral regurgitation	6 months	Echocardiogram parameter: degree of mitral regurgitation at baseline, 3 months and 6 months
Change in quality of life	6 months	Change in quality of life assessed by Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months.

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong