CardioInsight 1 RBBB

Heart Failure Clinical Trial

— CardioInsight1  

Official title:

Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555966
• Other study ID #: 2017.316
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2022
• Source: Chinese University of Hong Kong
• Contact: Daniel Xu
• Phone: 35051518
• Email: danielxu[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Device set-up parameter :defibrillation threshold	Device parameters including defibrillation threshold at implant and 6 months follow-up.	6 months
Secondary	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
Secondary	Device set-up parameter :defibrillation sensitivity	Device set-up parameter :defibrillation sensitivity at implant and 6 months follow-up	6 months
Secondary	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
Secondary	Change in 6 minute hall walk test	Change in 6 minute hall walk test result, at baseline, 3 months and 6 months.	6 months
Secondary	Change in HF Patient Global Assessment Questionnaire	HF Patient Global Assessment Questionnaire at baseline, 3 months and 6 months.	6 months
Secondary	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
Secondary	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
Secondary	Echocardiogram parameter: left ventricular ejection fraction	Echocardiogram parameter: left ventricular ejection fraction at baseline, 3 months and 6 months	6 months
Secondary	Echocardiogram parameter: degree of mitral regurgitation	Echocardiogram parameter: degree of mitral regurgitation at baseline, 3 months and 6 months	6 months
Secondary	Echocardiogram parameter: strain imaging	Echocardiogram parameter: strain imaging at baseline, 3 months and 6 months	6 months