PIANO

• Research type

  Research Study

• Full title

  Post Market Clinical Follow-Up of MicroPort CRM Cardiac Implantable Electronic Device systems

• IRAS ID

  331714

• Contact name

  David Sharman

• Contact email

  david.sharman@ngh.nhs.uk

• Sponsor organisation

  MicroPort CRM/SORIN CRM SAS

• Clinicaltrials.gov Identifier

  NCT05694572

• Duration of Study in the UK

  8 years, 0 months, 31 days

• Research summary

  The European current Medical Devices Regulation requires a continuous monitoring of the performances of active implantable medical devices after their commercial release.

  Therefore, the post market clinical follow-up, PIANO, will be conducted to collect long term clinical data on safety and performance of MicroPort CRM market-released systems - these are Pacemakers, Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronisation Therapy Defibrillators (CRTD's) and their associated leads.
  
  The study will obtain data of long term safety and performance via the sites standard practice of follow up for up to 5 years follow-up post-implantation.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  24/YH/0098

• Date of REC Opinion

  19 Jul 2024

• REC opinion

  Further Information Favourable Opinion