Evaluation of Performance & Safety of Lotus Edge Valve

• Research type

  Research Study

• Full title

  REPRISE EDGE Repositionable Percutaneous Replacement of Native Stenotic Aortic Valve through Implantation of LOTUS EDGE Valve System - Evaluation of Performance and Safety.

• IRAS ID

  209304

• Contact name

  Daniel Blackman

• Contact email

  Daniel.blackman1@nhs.net

• Sponsor organisation

  Boston Scientific

• Duration of Study in the UK

  1 years, 2 months, 1 days

• Research summary

  This is a prospective, single-arm clinical study designed to demonstrate that the acute performance and safety of the LOTUS Edge Valve System, when used with the iSleeve or Lotus Introducer Set, is consistent with the results of the commercially approved Lotus Valve System used in the REPRISE II study, when delivered and deployed in symptomatic patients who have severe calcific aortic valve stenosis and who are at high risk for surgical aortic valve replacement (SAVR).

  Study cohorts include the following.
  - A non-randomised, single-arm study independently powered to evaluate safety and effectiveness in patients treated with the LOTUS Edge™ Valve System.
  - A non-randomised roll-in phase; each centre will perform at least 1 roll-in case with the LOTUS Edge Valve System before commencing enrolment in the evaluable (primary endpoint) cohort. Data from roll-in patients will be summarised separately from the evaluable cohort. Roll-in patients will not be included in the primary endpoint analysis.
  The main objective of the study is the mean aortic valve pressure gradient at discharge or 7 days post-procedure (whichever comes first) as measured by echocardiography and assessed by an independent core laboratory.

  Patients will be enrolled from up to 10 centres in Europe, up to 60 patients will participate in REPRISE EDGE. Up to 10 participants will be enrolled and included in the roll-in phase (a minimum of 1 roll-in patient with the LOTUS Edge Valve System per centre) before commencing enrolment in the evaluable (primary endpoint) cohort. Up to 50 patients will be enrolled in the evaluable cohort. Patients implanted with a Lotus valve will be followed up for 12 months after the procedure.

• REC name

  Yorkshire & The Humber - South Yorkshire Research Ethics Committee

• REC reference

  16/YH/0353

• Date of REC Opinion

  26 Sep 2016

• REC opinion

  Further Information Favourable Opinion