Predicting Response to CRT Using Body Surface ECG Mapping

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: CRT Implant; Device: Body Surface ECG Mapping

• Registration Number: NCT01831518
• Lead Sponsor: Tom Jackson

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-15
• Study Start: 2014-07
• Primary Completion: 2016-06-01
• Study Completion: 2016-06-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRT Eligible	Body Surface ECG Mapping	ACC/AHA/HRS/ESC guidelines for device-based therapy
CRT Eligible	CRT Implant	ACC/AHA/HRS/ESC guidelines for device-based therapy

Primary Outcome Measures

Name	Time	Method
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
Change in distance travelled during six-minute walk test (6MWT)	Baseline and 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (2)

The Royal Brompton and Harefield NHS Foundation Trust; 🇬🇧 London, United Kingdom

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom