COS-TAVI Trial. Version 1.0

• Research type

  Research Study

• Full title

  Cost Outcomes Study of Transcatheter Aortic Valve Implantation with contemporary valves: COS-TAVI Trial

• IRAS ID

  363673

• Contact name

  Javaid Iqbal

• Contact email

  J.Iqbal@sheffield.ac.uk

• Sponsor organisation

  Sheffield Teaching Hospitals NHS Foundation Trust

• ISRCTN Number

  ISRCTN14725744

• Duration of Study in the UK

  1 years, 6 months, 0 days

• Research summary

  Transcatheter Aortic Valve Implantation (TAVI) procedure has been in clinical practice for several years for patients who suffer from significant symptoms due to a narrowed aortic valve and who cannot undergo an open heart operation due to various reasons, e.g. if they are elderly and are at high risk of complications after major operations. In these patients, TAVI procedure is a good alternative and has shown to improve quality of life and prognosis. There are several TAVI valves available; however, only three of them have been tested in randomised clinical trials. There is a continuous and significant increase in number of patients undergoing TAVI procedures every year. As these valves are expensive, this has resulted in significant burden on the NHS budget in treating these patients.

  The purpose of COS-TAVI trial is to assess if, following implantation, there is any difference between the three contemporary aortic transcatheter heart valves (THVs), i.e. Meril Myval THV Series, Edwards Sapien THV Series and Medtronic Evolut THV series, in:

  1) health related quality of life and
  2) cost-effectiveness of TAVI procedure

  This trial will provide valuable data which can be used to develop future guidance about how to manage these patients with aortic valve narrowing in a cost-effective manner.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  26/NE/0075

• Date of REC Opinion

  30 Apr 2026

• REC opinion

  Further Information Favourable Opinion