Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Procedure: Noninvasive electrical dyssynchrony study

• Registration Number: NCT03356652
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-23
• Study First Posted: 2017-11-29
• Study Start: 2018-03-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-19
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

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 -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

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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 (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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tailor-made CRT delivery	Noninvasive electrical dyssynchrony study	Patient undergoes acute noninvasive electrical dyssynchrony study with various CRT configurations. CRT device is then implanted with optimal configuration.

Primary Outcome Measures

Name	Time	Method
Responder rate of greater than 10% of LV end systolic volume reduction in patients undergoing tailor-made approach of CRT delivery at 6 months.	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.

Secondary Outcome Measures

Name	Time	Method
The hemodynamic responses of different methods of CRT delivery.	during procedure	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.
Peri-operative and 6 months follow-up complications rate:	Peri-operative and 6 months	1. Thromboembolic event; 2. Dislodgement and migration of pacing leads; 3. Phrenic nerve stimulation; 4. Others
NYHA class	baseline and 6 months	NYHA class at baseline and 6 months.
Quality of life using Minnesota's questionnaire	baseline and 6 months	Quality of life using Minnesota's questionnaire at baseline and 6 months.
Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up.	during procedure and 6 months	Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up.
Procedure duration of the optimal CRT delivery method	during procedure	Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
The acute electrical dyssynchrony indices of different methods of CRT delivery.	during procedure	The acute electrical dyssynchrony indices of different methods of CRT delivery.
Implantation success rate of the optimal CRT delivery method	during procedure	Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view)	during procedure	Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view)
Left ventricular systolic and diastolic volume at baseline and 6 months:	baseline and 6 months	Echocardiogram parameter of left ventricular systolic and diastolic volume at baseline and 6 months.
Left ventricular ejection fraction at baseline and 6 months:	baseline and 6 months	Echocardiogram parameter of left ventricular ejection fraction at baseline and 6 months.
6 minute hall walk test	baseline and 6 months	6 minute hall walk test at baseline and 6 months.
Degree of mitral regurgitation at baseline and 6 months:	baseline and 6 months	Echocardiogram parameter of degree of mitral regurgitation at baseline and 6 months.
Strain imaging at baseline and 6 months:	baseline and 6 months	Echocardiogram parameter of strain imaging at baseline and 6 months.

Trial Locations

Locations (1)

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