Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy

October 18, 2021 updated by: Professor Bryan Ping Yen YAN, Chinese University of Hong Kong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong
        • Contact:
        • Sub-Investigator:
          • Joseph YS Chan
        • Principal Investigator:
          • Bryan PY Yan
        • Sub-Investigator:
          • Gary CP Chan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 -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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tailor-made CRT delivery
Patient undergoes acute noninvasive electrical dyssynchrony study with various CRT configurations. CRT device is then implanted with optimal configuration.
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.

Other Names:
  • Noninvasive electrical activation
  • Electrical Activation Mapping
  • Noninvasive mapping system
  • ECVUE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder rate of greater than 10% of LV end systolic volume reduction in patients undergoing tailor-made approach of CRT delivery at 6 months.
Time Frame: 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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Bryan PY YAN, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2018

Primary Completion (Anticipated)

August 31, 2024

Study Completion (Anticipated)

August 31, 2024

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 23, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUHK-MAPCRT-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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