EMPIRE-NVT ALLEGRA THV System with a new delivery system

• Research type

  Research Study

• Full title

  InvEstigation of the safety and perforMance of the NVT ALLEGRA THV System with a new delivery system in Patients with severe calcified aortIc stenosis or failed suRgical aortic bioprosthEsis (EMPIRE)

• IRAS ID

  319703

• Contact name

  David Andrew Smith

• Contact email

  Dave.Smith@wales.nhs.uk

• Sponsor organisation

  NVT GmbH

• Clinicaltrials.gov Identifier

  NCT05478161

• Clinicaltrials.gov Identifier

  CIV-22-07-039967, CIV-ID

• Duration of Study in the UK

  1 years, 8 months, 0 days

• Research summary

  The ALLEGRA THV System is designed to replace a severely stenotic calcified native aortic heart valve without open heart surgery. It can also be used to replace failing surgical bioprosthetic aortic heart valve without concomitant surgical removal of the failing valve.
  It consists of:
  1. ALLEGRA Transcatheter Heart Valve (THV), made of a self-expandable nitinol stent and bovine pericardium, available in 3 size configurations (ALLEGRA 23/27/31). The ALLEGRA THV is available on the market in Europe.
  2. IMPERIA Delivery System that allows re-sheathing and re-positioning of the ALLEGRA THV.

• REC name

  South East Scotland REC 02

• REC reference

  23/SS/0013

• Date of REC Opinion

  8 Mar 2023

• REC opinion

  Further Information Favourable Opinion