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Completed

NCT Number: NCT01831518

Predicting Response to CRT Using Body Surface ECG Mapping

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRT Implant

Device

Other names: Cardiac Resynchronization, Biventricular Pacemaker

Body Surface ECG Mapping

Device

Other names: ECG Imaging

Primary outcomes

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

    Time frame: Baseline and 6 months

  2. Echocardiographic: signs of LV reverse remodelling

    Time frame: 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 outcomes

  1. Symptoms

    Time frame: Baseline and 6 months

    Change in symptoms severity assessed by Minnesota Living With Heart Failure Questionnaire (MLHFQ)

  2. Neurohormonal status

    Time frame: Baseline and 6 Months

    Change in neurohormonal activation assessed by brain-natriuretic peptide (BNP)

  3. Pacing

    Time frame: 6 months

    Atrial and ventricular arrhythmic burden, percentage of bi-ventricular pacing

Sponsors and collaborators

Lead sponsor

Tom Jackson

Other

Collaborators

  • CardioInsight Technologies, Inc.
  • Royal Brompton & Harefield NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2013
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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