MIRACLE EF

• Research type

  Research Study

• Full title

  MIRACLE EF (Ejection Fraction) Clinical Study

• IRAS ID

  126672

• Contact name

  Martin Cowie

• Contact email

  m.cowie@imperial.ac.uk

• Sponsor organisation

  Medtronic Inc

• Clinicaltrials.gov Identifier

  NCT01735916

• Research summary

  Cardiac Resynchronisation Therapy (CRT) is a CE-marked treatment currently indicated for some patients in Heart Failure (HF). It uses a pacemaker to electronically stimulate the lower heart chambers (ventricles) in a synchronised fashion, to increase the amount of blood ejected from the left ventricle with each heartbeat. This ejected amount of blood is called ejection fraction (EF).

  A healthy individual’s heart can eject the majority of blood that enters it, out though its left ventricle, the heart does this with each heartbeat to maintain circulation in the body. In HF patients this ability of the heart diminishes gradually, and the patient is said to have a reduced ejection fraction.

  EF is measured as a percentage, which decreases over time with worsening of HF. For example a patient with EF of over 60% is considered to have a relatively healthy heart. Reduction of EF to 50% may be taken to signal the beginning stages of HF. At 35% the patient is considered to be in severe HF and prescribed a CRT pacemaker (CRT-P) per national guidelines.
  The patient population between 50%-36% (mild to moderate HF) may also be provided access to CRT-P therapy at the discretion of their physician, depending on their symptoms. The aim of this study is to evaluate the benefits of CRT-P specifically in this patient population.

  The outcome of the study will provide further evidence for review of guidelines (ACC/AHA, ESC) regarding the use of CRT in patients with mild to moderate HF in the UK, Europe and world-wide, and to support modification of existing US and Japanese labelling for Medtronic’s CRT-P devices.

  Eligible patients will be informed about the study, consented in accordance to ethical guidelines, enrolled, implanted with CRT-P, randomized and followed up for 3 years.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  13/LO/0686

• Date of REC Opinion

  12 Jul 2013

• REC opinion

  Favourable Opinion