TYRX pocket health study

• Research type

  Research Study

• Full title

  TYRX™ Pocket Health Study

• IRAS ID

  315215

• Contact name

  Jay Wright

• Contact email

  Jay.Wright@lhch.nhs.uk

• Sponsor organisation

  Medtronic Inc

• Duration of Study in the UK

  0 years, 3 months, 14 days

• Research summary

  Medtronic, Inc. is sponsoring the TYRX Pocket Health Study, a prospective, multi-center, single-arm, post-market non-interventional clinical study, to evaluate the morphometry and histopathology of the device capsule in subjects who underwent a transvenous cardiovascular implantable electronic device(CIED) procedure with a TYRX™ Absorbable Antibacterial Envelope and are returning for a CIED replacement procedure.
  The TYRX envelope mentioned is approved by the authorities for use by doctors in the management of patients who have a CIED. It is routinely available as part of normal clinical care and is not experimental. There are no investigational devices used in this study. For this study, we will only be collecting data.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  22/PR/0701

• Date of REC Opinion

  14 Jul 2022

• REC opinion

  Further Information Favourable Opinion