Venus P-Valve study, version A, Jan 2015

• Research type

  Research Study

• Full title

  Implantation of the Venus P-ValveTM in the Pulmonic Position In Patients with Native Outflow Tracts

• IRAS ID

  172972

• Contact name

  Veronica Jin

• Sponsor organisation

  Venus Medtech (Hangzhou), Inc.

• Duration of Study in the UK

  3 years, 11 months, 31 days

• Research summary

  This is a prospective, non-randomized, multi-center clinical investigation. The purpose of this protocol is to assess the safety and performance of the medical device. The study population consists of patients ≥12 years with a body weight of ≥30kg. 40 subjects in the EU with 80 subjects worldwide will be included in the study. Up to 5 sites in the EU and 10 sites worldwide are planned to participate. The study duration will be 4 years (12-month enrollment period and a follow-up period of 3 years).

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  15/LO/1085

• Date of REC Opinion

  3 Sep 2015

• REC opinion

  Further Information Favourable Opinion