SOLVE-CRT (v1.3)

• Research type

  Research Study

• Full title

  Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients (SOLVE CRT)

• IRAS ID

  228696

• Contact name

  Christopher Rinaldi

• Contact email

  Aldo.Rinaldi@gstt.nhs.uk

• Sponsor organisation

  EBR Systems Inc.

• Clinicaltrials.gov Identifier

  NCT02922036

• Duration of Study in the UK

  3 years, 3 months, 31 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 are considered untreated due to acute or chronic issues with the CS lead
  • 30% of patients do not respond or improve
  • 23% of patients have a complex upgrade from an existing pacemaker or ICD

  The WiSE-CRT 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 WiSE-CRT System operates alongside a co-implanted pacemaker, defibrillator or CRT system and replaces the pacing function of the CS lead.

  The WiSE-CRT System received CE Mark in September 2015. This global, multi-centre, randomized, two-arm, double blinded, prospective study is assess safety and effectiveness in a larger set of patients than previously studied. 350 patients across Europe, USA and Australia will be enrolled over an 18-month period and followed up for 24-months at intervals of 1-month, 3-months, 6-months, then every 6-months.

  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 to participate.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  17/LO/1261

• Date of REC Opinion

  29 Sep 2017

• REC opinion

  Further Information Favourable Opinion