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Predicting Response to CRT Using Body Surface ECG Mapping

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

CRT Implant

Body Surface ECG Mapping

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Heart Failure, Cardiac Resynchronization Therapy, ECG Imaging, Body Surface Mapping

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Guy's and St Thomas' NHS Foundation Trust
The Royal Brompton and Harefield NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CRT Eligible

Arm Description

ACC/AHA/HRS/ESC guidelines for device-based therapy

Outcomes

Primary Outcome Measures

Change in distance travelled during six-minute walk test (6MWT)

Echocardiographic: signs of LV reverse remodelling

Increase by >5% in left ventricular ejection fraction with an associated decrease in LV end-diastolic (LVEDV) and end-systolic (LVESV) volumes

Secondary Outcome Measures

Symptoms

Change in symptoms severity assessed by Minnesota Living With Heart Failure Questionnaire (MLHFQ)

Neurohormonal status

Change in neurohormonal activation assessed by brain-natriuretic peptide (BNP)

Pacing

Atrial and ventricular arrhythmic burden, percentage of bi-ventricular pacing

Full Information

NCT ID

NCT01831518

First Posted

April 4, 2013

Last Updated

October 4, 2018

Sponsor

Tom Jackson

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01831518

Brief Title

Predicting Response to CRT Using Body Surface ECG Mapping

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

June 1, 2016 (Actual)

Study Completion Date

June 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Tom Jackson

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Heart Failure, Cardiac Resynchronization Therapy, ECG Imaging, Body Surface Mapping

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CRT Eligible

Arm Type

Experimental

Arm Description

ACC/AHA/HRS/ESC guidelines for device-based therapy

Intervention Type

Device

Intervention Name(s)

CRT Implant

Other Intervention Name(s)

Cardiac Resynchronization, Biventricular Pacemaker

Intervention Type

Device

Intervention Name(s)

Body Surface ECG Mapping

Other Intervention Name(s)

ECG Imaging

Primary Outcome Measure Information:

Title

Change in distance travelled during six-minute walk test (6MWT)

Time Frame

Baseline and 6 months

Title

Echocardiographic: signs of LV reverse remodelling

Description

Increase by >5% in left ventricular ejection fraction with an associated decrease in LV end-diastolic (LVEDV) and end-systolic (LVESV) volumes

Time Frame

Baseline and 6 months

Secondary Outcome Measure Information:

Title

Symptoms

Description

Change in symptoms severity assessed by Minnesota Living With Heart Failure Questionnaire (MLHFQ)

Time Frame

Baseline and 6 months

Title

Neurohormonal status

Description

Change in neurohormonal activation assessed by brain-natriuretic peptide (BNP)

Time Frame

Baseline and 6 Months

Title

Pacing

Description

Atrial and ventricular arrhythmic burden, percentage of bi-ventricular pacing

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Guy's and St Thomas' NHS Foundation Trust

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

The Royal Brompton and Harefield NHS Foundation Trust

City

London

ZIP/Postal Code

SW3 6NP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

31201592

Citation

Jackson T, Claridge S, Behar J, Sieniewicz B, Gould J, Porter B, Sidhu B, Yao C, Lee A, Niederer S, Rinaldi CA. Differential effect with septal and apical RV pacing on ventricular activation in patients with left bundle branch block assessed by non-invasive electrical imaging and in silico modelling. J Interv Card Electrophysiol. 2020 Jan;57(1):115-123. doi: 10.1007/s10840-019-00567-2. Epub 2019 Jun 14.

Results Reference

derived

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Predicting Response to CRT Using Body Surface ECG Mapping

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