Spyral Affirm

• Research type

  Research Study

• Full title

  The SPYRAL AFFIRM Global Clinical Study of Renal Denervation with the Symplicity Spyral Renal Denervation System in Subjects with Uncontrolled Hypertension (SPYRAL AFFIRM)

• IRAS ID

  312686

• Contact name

  Andrew Sharp

• Contact email

  andrew.sharp@wales.nhs.uk

• Sponsor organisation

  Medtronic Bakken Research Center

• Duration of Study in the UK

  5 years, 1 months, 22 days

• Research summary

  The SPYRAL AFFIRM study will evaluate the long-term safety, efficacy, and
  durability of the Symplicity Spyral system in a population of a minimum of
  750 and up to 1000 renal denervation treated subjects with up to 36
  months of follow-up, including several sub-populations. Subsequently,
  these data will be used to complement data from the SPYRAL PIVOTAL SPYRAL
  HTN-OFF MED trial, SPYRAL HTN-ON MED trial, as well as the Global SYMPLICITY Registry.
  Additionally, in order to gather long-term follow-up data, up to 200
  eligible subjects, initially randomized to the treatment arm in the SPYRAL
  PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies and
  successfully treated via the renal denervation procedure, are eligible to
  be consented for continued follow up in the SPYRAL AFFIRM study at time
  of exit from the prior study. These subjects will attend follow up visits at
  48 month and 60 month post renal denervation procedure they received
  during the aforementioned studies

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  23/LO/0375

• Date of REC Opinion

  28 Jun 2023

• REC opinion

  Further Information Favourable Opinion