Clinical trial NCT01831518: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Cardiac Resynchronization Therapy
ECG Imaging
Body Surface Mapping
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
name: CardioInsight Technologies, Inc.
First posted: 2013-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Change in distance travelled during six-minute walk test (6MWT)
timeFrame: Baseline and 6 months
measure: Echocardiographic: signs of LV reverse remodelling
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Symptoms
timeFrame: Baseline and 6 months
measure: Neurohormonal status
timeFrame: Baseline and 6 Months
measure: Pacing
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Brompton and Harefield NHS Foundation Trust
Study officials:
References:
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.