Predicting Response to CRT Using Body Surface ECG Mapping

Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831518
• Other study ID #: STHCIT1
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: June 1, 2016

Study information

• Verified date: October 2018
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CRT Implant

• Body Surface ECG Mapping

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	The Royal Brompton and Harefield NHS Foundation Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Tom Jackson	CardioInsight Technologies, Inc., Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in distance travelled during six-minute walk test (6MWT)		Baseline and 6 months
Primary	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	Baseline and 6 months
Secondary	Symptoms	Change in symptoms severity assessed by Minnesota Living With Heart Failure Questionnaire (MLHFQ)	Baseline and 6 months
Secondary	Neurohormonal status	Change in neurohormonal activation assessed by brain-natriuretic peptide (BNP)	Baseline and 6 Months
Secondary	Pacing	Atrial and ventricular arrhythmic burden, percentage of bi-ventricular pacing	6 months