Venus P-Valve Registry Study

• Research type

  Research Study

• Full title

  A Real-World Evidence Observational Study of Venus P-Valve System in the Treatment of Patients with Native RVOT Dysfunction Protocol Number: VTPP-22-08 Version 1.0 January 1, 2023

• IRAS ID

  327607

• Contact name

  Shakeel Qureshi

• Contact email

  Shakeel.Qureshi@gstt.nhs.uk

• Sponsor organisation

  Venus Medtech (Hangzhou) Inc.

• ISRCTN Number

  ISRCTN43511000

• Clinicaltrials.gov Identifier

  NCT05835349

• Duration of Study in the UK

  7 years, 6 months, 0 days

• Research summary

  Real-world evidence, prospective, non-randomized, multicenter observational study of Venus P-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).

  All subjects will be followed over 5 years for the observed outcome measures, which will be analyzed and documented following regulatory specifications.

  Post-procedure, a clinical visit will be scheduled at discharge, 30 days, 6 months, 1 year and annually, to 5 years.

  Clinical data will be collected from at least 10 centers, with data available on patients who have completed the 5 years follow-up visit. At least 200 patients will be enrolled in this study.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  24/YH/0046

• Date of REC Opinion

  14 Mar 2024

• REC opinion

  Unfavourable Opinion