Status:

COMPLETED

Predicting Response to CRT Using Body Surface ECG Mapping

Lead Sponsor:

Tom Jackson

Collaborating Sponsors:

Royal Brompton & Harefield NHS Foundation Trust

CardioInsight Technologies, Inc.

Conditions:

Heart Failure

Eligibility:

All Genders

18+ years

Phase:

NA

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 c...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2016

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT01831518

Start Date

July 1 2014

End Date

June 1 2016

Last Update

October 5 2018

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom, SE1 7EH

2

The Royal Brompton and Harefield NHS Foundation Trust

London, United Kingdom, SW3 6NP