Predicting Response to CRT Using Body Surface ECG Mapping

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01831518

Enrollment

Registered

2013-04-15

Start date

2014-07-31

Completion date

2016-06-01

Last updated

2018-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

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

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.

Interventions

DEVICECRT Implant

DEVICEBody Surface ECG Mapping

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026