Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy

Heart Failure Clinical Trial

Official title:

Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03356652
• Other study ID #: CUHK-MAPCRT-1
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2018
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2021
• Source: Chinese University of Hong Kong
• Contact: Olivia TO
• Phone: (852) 3505 1750
• Email: oliviato[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, a good response is observed in less than 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 poor response to CRT. Purpose of the clinical investigation The purpose of the Electrical Activation Guided CRT Study is to study the effectiveness of 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 implantation procedure. Conduct of the Investigation This study will include 93 patients with conduction abnormality that known to have a poor response to CRT from Prince of Wales Hospital, Hong Kong.Subjects will be followed up at 3 months and 6 months visit.

Description:

The purpose is to prospectively study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation. Study Hypothesis: Tailor-made configuration of CRT delivery is feasible and able to improve responder rate compare to single method of CRT delivery in candidates with known poor response to CRT. Primary outcome measure: Responder rate of greater than 10% of LV end systolic volume reduction in patients undergoing tailor-made approach of CRT delivery at 6 months. The responder rate is to compare with pre-defined level of 40% for single method of CRT delivery namely biventricular pacing with LV lead in coronary sinus. Sample Size: The total required sample size is 93 patients with device implanted.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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 -LBBB type of conduction disturbance
• NYHA class III or above
• Sinus rhythm
• 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 (eg mechanical aortic valve, severe aortic stenosis and aortic dissection) *The definitions of LBBB (QRS duration =130 ms; QS or rS in lead V1; broad R waves in leads I, aVL, V5, or V6; and absent q waves in leads I, V5, and V6).

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Noninvasive electrical dyssynchrony study
Ventricular activation maps will be acquired simultaneously with hemodynamic measurements using noninvasive mapping system (ECVUE, Medtronic Inc, USA). A thoracic computed tomographic scan will be acquired with the electrodes attached to the patient. Local ventricular activation times will be defined as the onset of the QRS complex or the pacing spike to the maximal negative slope of each unipolar electrogram. Pacing leads will be placed in high right atrium, His-bundle region, right ventricular apex, high septal RV, coronary sinus posterior/lateral branch, coronary sinus anterior branch, lateral and septal region of endocardial LV in order to deliver CRT in 8 different configurations.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rate of greater than 10% of LV end systolic volume reduction in patients undergoing tailor-made approach of CRT delivery at 6 months.	Responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram comparing baseline and 6 months post implant in patients undergoing tailor-made approach of CRT delivery. Responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram comparing baseline and 6 months post implant in patients undergoing tailor-made approach of CRT delivery. The responder rate is to compare with pre-defined level of 40% for single method of CRT delivery namely biventricular pacing with LV lead in coronary sinus.	6 months
Secondary	The acute electrical dyssynchrony indices of different methods of CRT delivery.	The acute electrical dyssynchrony indices of different methods of CRT delivery.	during procedure
Secondary	The hemodynamic responses of different methods of CRT delivery.	The 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
Secondary	Procedure duration of the optimal CRT delivery method	Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.	during procedure
Secondary	Implantation success rate of the optimal CRT delivery method	Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.	during procedure
Secondary	Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view)	Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view)	during procedure
Secondary	Peri-operative and 6 months follow-up complications rate:	Thromboembolic event; Dislodgement and migration of pacing leads; Phrenic nerve stimulation; Others	Peri-operative and 6 months
Secondary	Left ventricular systolic and diastolic volume at baseline and 6 months:	Echocardiogram parameter of left ventricular systolic and diastolic volume at baseline and 6 months.	baseline and 6 months
Secondary	Left ventricular ejection fraction at baseline and 6 months:	Echocardiogram parameter of left ventricular ejection fraction at baseline and 6 months.	baseline and 6 months
Secondary	Degree of mitral regurgitation at baseline and 6 months:	Echocardiogram parameter of degree of mitral regurgitation at baseline and 6 months.	baseline and 6 months
Secondary	Strain imaging at baseline and 6 months:	Echocardiogram parameter of strain imaging at baseline and 6 months.	baseline and 6 months
Secondary	NYHA class	NYHA class at baseline and 6 months.	baseline and 6 months
Secondary	6 minute hall walk test	6 minute hall walk test at baseline and 6 months.	baseline and 6 months
Secondary	Quality of life using Minnesota's questionnaire	Quality of life using Minnesota's questionnaire at baseline and 6 months.	baseline and 6 months
Secondary	Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up.	Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up.	during procedure and 6 months