TRINITY

• Research type

  Research Study

• Full title

  TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT with LuX-Valve Plus System in Patients with Severe or Greater Tricuspid Regurgitation -- SafetY and Clinical Performance

• IRAS ID

  319356

• Contact name

  Tiffany Patterson

• Contact email

  tiffany.patterson@gstt.nhs.uk

• Clinicaltrials.gov Identifier

  NCT05436028

• Clinicaltrials.gov Identifier

  EUDAMED, CIV-22-10-040995

• Duration of Study in the UK

  6 years, 0 months, 31 days

• Research summary

  The study is intended to evaluate the safety and clinical performance of the LuX-Valve Plus System in the treatment of patients with severe or greater tricuspid regurgitation (TR) who are at high risk for tricuspid valve surgery.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  23/WM/0060

• Date of REC Opinion

  6 Jun 2023

• REC opinion

  Further Information Favourable Opinion