INGEVITY

• Research type

  Research Study

• Full title

  INGEVITY™ Observational Trial: Assessment of Routine Experience and MRI Usage With a New Lead for Bradycardia Pacing

• IRAS ID

  163885

• Contact name

  Elisa Vireca

• Contact email

  elisa.vireca@bsci.com

• Sponsor organisation

  Boston Scientific

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  This is a registry study. The objectives of this registry are to:
  
  1. Collect clinical data on Boston Scientific’s ImageReady MR
  Conditional Pacing Systems involving the INGEVITY lead
  based on observations / events
  2. Gather data on actual number of MRI scans performed in the
  patient cohort implanted with an ImageReady system
  including information about scanned body parts.
  3. Collect physician feedback on lead handling with the
  INGEVITY lead

  in a real-life, market-released standard of care environment using
  devices on intended purpose and which are authorized to bear the CE
  marking / are approved for use in the applicable area of participating
  centers. No additional invasive or other burdensome examinations are
  to be carried out other than the ones conducted by the centers per their
  general standard of care.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  14/SC/1443

• Date of REC Opinion

  16 Dec 2014

• REC opinion

  Favourable Opinion