Predicting Response to CRT Using Body Surface ECG Mapping

Sponsor

Tom Jackson (Other)

Overall Status

Completed

CT.gov ID

NCT01831518

Collaborator

Royal Brompton & Harefield NHS Foundation Trust (Other), CardioInsight Technologies, Inc. (Industry)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: CRT Implant Device: Body Surface ECG Mapping	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in distance travelled during six-minute walk test (6MWT) [Baseline and 6 months]
Echocardiographic: signs of LV reverse remodelling [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guy's and St Thomas' NHS Foundation Trust	London		United Kingdom	SE1 7EH
2	The Royal Brompton and Harefield NHS Foundation Trust	London		United Kingdom	SW3 6NP