MORE-CRT MPP

• Research type

  Research Study

• Full title

  “MOre REsponse on Cardiac Resynchronization Therapy (CRT) with MultiPoint Pacing (MPP)”

• IRAS ID

  138192

• Contact name

  Christopher Aldo Rinaldi

• Contact email

  aldo.rinaldi@gstt.nhs.uk

• Research summary

  The purpose of this Clinical investigation is to assess the impact of the Multi
  Point Pacing (MPP) feature at 12 months in the treatment of patients not
  responding to standard Cardiac Resynchronization Therapy (CRT) after 6
  Months.

  CRT is the treatment of choice for heart failure and has been shown to improve heart function and quality of life in a high percentage of patients. However, some patients do not respond to CRT and show no improvements in heart function or health.
  Current Cardiac resynchronisation devices can only pace the heart from one electrode.
  The devices involved in this study have the capability to pace the left side of the heart from two different electrodes on the Quadra polar. Previous studies have shown that by capturing more of the left ventricle this improves heart function, hence haemodynamics and may benefit those patients who are otherwise identified as non-responders.
  The cohort involved in this study has standard clinical indications for CRT.
  It is estimated that the study will last for 42 months-24 months to recruit the 1256 patient population, 12 months for follow up and 6 months for study closure.

  This study is designed as a Prospective, Randomized, Multi-centre Trial.
  Data will be collected at Enrolment, Baseline, Implant Procedure, Patient
  Classification, 6 Months and 12 Months Follow-Up.
  During the Enrolment visit, the Informed Consent Procedure will be performed
  and the Inclusion/Exclusion criteria verified.
  During the Baseline visit the demographic data, medical history, clinical data
  and procedure details will be collected.
  After the Implant Procedure, the Patient Classification will be performed in
  order to identify the Qualified Subjects that will constitute the Study Population.

  6 Months visit, the patient’s response to CRT will be evaluated
  according to their heart function.
  12 Months visit, the percentage of non-responder patients
  converted to responders after 6 months of MPP feature turned ON will be
  assessed

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  13/LO/1891

• Date of REC Opinion

  3 Feb 2014

• REC opinion

  Further Information Favourable Opinion