The “Global Paradise System” Registry - UK Version A

• Research type

  Research Study

• Full title

  The “Global Paradise System” Registry

• IRAS ID

  316868

• Contact name

  Manish Saxena

• Contact email

  m.saxena@nhs.net

• Sponsor organisation

  ReCor Medical Inc.

• Clinicaltrials.gov Identifier

  NCT05027685

• Duration of Study in the UK

  8 years, 0 months, 0 days

• Research summary

  The objective of the GPS Registry is to document the long-term safety and effectiveness of Ultrasound Renal Denervation (uRDN), using the Paradise Ultrasound Renal Denervation System, when used according to its labelling, in patients deemed to be candidates for uRDN as per their physician’s assessment.
  It is an international, multi-centre, single-arm, observational study. In addition to collecting data from patients treated as per standard clinical practice, the study will also regularly collect telemetric Home Blood Pressure (HBP) measurements, as well as Patient Reported Outcome (PRO) data via a standardised quality of life questionnaire.
  The GPS Registry will collect both retrospective and prospective data in up to 3000 patients treated with the Paradise Ultrasound Renal Denervation System. Each subject will be followed-up for 5 years following their uRDN procedure.
  Safety will be assessed by the collection of Adverse Event data.
  Effectiveness will be assessed by monitoring blood pressures, anti-hypertensive medical treatments and quality of life scores.

• REC name

  Wales REC 7

• REC reference

  23/WA/0056

• Date of REC Opinion

  28 Feb 2023

• REC opinion

  Favourable Opinion