NCT01831518

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

April 4, 2013

Last Update Submit

October 4, 2018

Conditions

Heart Failure

Keywords

Heart FailureCardiac Resynchronization TherapyECG ImagingBody Surface Mapping

Outcome Measures

Primary Outcomes (2)

  • Change in distance travelled during six-minute walk test (6MWT)

    Baseline and 6 months

  • 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 Outcomes (3)

  • Symptoms

    Baseline and 6 months

  • Neurohormonal status

    Baseline and 6 Months

  • Pacing

    6 months

Study Arms (1)

CRT Eligible

EXPERIMENTAL

ACC/AHA/HRS/ESC guidelines for device-based therapy

Device: CRT ImplantDevice: Body Surface ECG Mapping

Interventions

CRT ImplantDEVICE
Also known as: Cardiac Resynchronization, Biventricular Pacemaker
CRT Eligible
Body Surface ECG MappingDEVICE
Also known as: ECG Imaging
CRT Eligible

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

The Royal Brompton and Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31201592DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization TherapyCardiac Resynchronization Therapy Devices

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeuticsPacemaker, ArtificialElectrodesElectrical Equipment and SuppliesEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

April 4, 2013

First Posted

April 15, 2013

Study Start

July 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 5, 2018

Record last verified: 2018-10

Locations

GB(2)