WiCS-LV Post Market Surveillance Registry

• Research type

  Research Study

• Full title

  WiCS-LV Post Market Surveillance Registry

• IRAS ID

  193993

• Contact name

  Christopher Rinaldi

• Contact email

  Aldo.Rinaldi@gstt.nhs.uk

• Sponsor organisation

  EBR Systems Inc.

• Clinicaltrials.gov Identifier

  NCT02610673

• Duration of Study in the UK

  5 years, 6 months, days

• Research summary

  Heart Failure is a serious condition in which the heart is unable to pump enough blood to meet the body's demands. Some heart failure occurs when the heart chambers pump in a desynchronised manner, reducing the amount of blood pumped with each heart beat.

  NICE recommends Cardiac Resynchronisation Therapy (CRT) for a subset of these patients. Patients undergoing CRT receive a special implantable pacemaker or defibrillator with an additional lead (CS) to synchronise the pumping of the heart chambers (ventricles). CRT works by pacing both the left & right ventricles to ensure they pump at the same time. This in turn, reduces heart failure symptoms.

  CRT is an effective treatment for many patients, but limitations prevent some patients from benefiting:
  • 5 to 10% of patients fail to have the CS lead implanted
  • 2 to 5% of patients have a chronic issue related the CS lead
  • 30% of patients fail treatment
  • 23% of patients have a complex upgrade from an existing pacemaker or ICD

  The WiCS-LV System is an implantable pacing system capable of delivering pacing energy to the heart without using a pacing lead. It was designed to address the persistent limitations of current CRT systems. The WiCS-LV System operates alongside a co-implanted pacemaker, defibrillator or CRT system and replaces the pacing function of the CS lead.

  The WiCS-LV System received CE Mark in September 2015. This Post Market Surveillance Registry is designed to collect performance data in normal conditions of use.

  100 patients across Europe will be enrolled over an 18-month period and followed up for 5-years at intervals of 1-week, 3-months, 6-months, 12-months, then annually.

  Patients who have had a CS lead failure, received a CRT device and failed treatment, or require an upgrade to a CRT device would be invited.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  16/LO/0194

• Date of REC Opinion

  12 Feb 2016

• REC opinion

  Favourable Opinion