Tendyne Mitral Study

• Research type

  Research Study

• Full title

  Early Feasibility Study of Tendyne Mitral Valve System

• IRAS ID

  180600

• Contact name

  Neil Moat

• Contact email

  N.Moat@rbht.nhs.uk

• Sponsor organisation

  Tendyne Holdings, Inc.

• Clinicaltrials.gov Identifier

  NCT02321514

• Duration of Study in the UK

  2 years, 6 months, days

• Research summary

  The purpose of this study is to generate initial insights into the safety of the Tendyne Mitral Valve System with its associated procedure and observe the device performance on its intended function of reducing mitral valve regurgitation. Information garnered from this study may be used to improve the device system, improve implantation techniques, refine the patient population for whom the device is intended and/or form the basis for the development of subsequent clinical protocols.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  15/LO/1891

• Date of REC Opinion

  7 Mar 2016

• REC opinion

  Further Information Favourable Opinion