Predicting Response to CRT Using Body Surface ECG Mapping

October 4, 2018 updated by: Tom Jackson

Evaluation of a Novel Method of Non-surface Electrocardiographic Mapping in Predicting Clinical, Structural and Neurohormonal Responses in Patients Undergoing Cardiac Resynchronization Therapy.

Cardiac resynchronization therapy (CRT) involves pacing the left and right side of the heart in order to improve the coordination of the contraction in patients with heart failure. Current selection criteria incorporate the severity of the symptoms, the mechanical function of the heart and the time it takes the electrical stimulation to spread over the left ventricle (as assessed on the standard 12 lead electrocardiogram-ECG). Unfortunately these criteria only seem to select approximately 70% of the patients who might respond to this invasive therapy. Body surface ECG mapping is a new technique that assesses the electrical activation of the heart in more detail than the standard ECG. This study aims to determine whether this new technology may aid current selection criteria in predicting response to CRT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom, SW3 6NP
        • The Royal Brompton and Harefield NHS Foundation Trust

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:

  • Age >18 years old
  • Fulfils established clinical criteria for CRT implantation (with or without a defibrillator)
  • NYHA Class III-IV Heart Failure (or NYHA II with NYHA III/IV symptoms in the preceding 12 months)
  • LVEF <35% (Calculated using echocardiography or Cardiac MR) at the time of implantation
  • QRS duration > 130ms
  • Optimal Tolerated Medical Therapy for Heart Failure

Exclusion Criteria:

  • Severe, life threatening non cardiac disease
  • Active malignant disease and recent (<5 years) malignant disease
  • Prior Heart Transplant
  • Recent history of unstable angina, acute coronary syndrome or myocardial infarction within three months of enrolment into the study
  • Pregnancy
  • Failure to participate in consent process
  • Atrial Fibrillation
  • Conventional pacemaker in situ
  • Heart Failure requiring constant intravenous therapy including diuretics and/or inotropes
  • Recent revascularisation procedure i.e. coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the last three months

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: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CRT Eligible
ACC/AHA/HRS/ESC guidelines for device-based therapy
Device: CRT Implant
Other Names:
  • Cardiac Resynchronization
  • Biventricular Pacemaker
Device: Body Surface ECG Mapping
Other Names:
  • ECG Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in distance travelled during six-minute walk test (6MWT)
Time Frame: Baseline and 6 months
Baseline and 6 months
Echocardiographic: signs of LV reverse remodelling
Time Frame: Baseline and 6 months
Increase by >5% in left ventricular ejection fraction with an associated decrease in LV end-diastolic (LVEDV) and end-systolic (LVESV) volumes
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms
Time Frame: Baseline and 6 months
Change in symptoms severity assessed by Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Baseline and 6 months
Neurohormonal status
Time Frame: Baseline and 6 Months
Change in neurohormonal activation assessed by brain-natriuretic peptide (BNP)
Baseline and 6 Months
Pacing
Time Frame: 6 months
Atrial and ventricular arrhythmic burden, percentage of bi-ventricular pacing
6 months

Collaborators and Investigators

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

Sponsor

Tom Jackson

Collaborators

Royal Brompton & Harefield NHS Foundation Trust
CardioInsight Technologies, Inc.

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

July 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (ESTIMATE)

April 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STHCIT1

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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