COLIBRI Version 3.0 dated 9 Oct 2019

• Research type

  Research Study

• Full title

  A prospective, single arm clinical investigation evaluating safety and performance of the Colibri Transcatheter Aortic Heart Valve System for the treatment of symptomatic severe aortic stenosis via transfemoral access in high surgical risk patients

• IRAS ID

  271455

• Contact name

  Julie ROSS

• Contact email

  jross@colibrihv.com

• Sponsor organisation

  Colibri Heart Valve LLC

• Clinicaltrials.gov Identifier

  NCT04029844

• Duration of Study in the UK

  5 years, 6 months, 0 days

• Research summary

  Prolonged average life expectancy has resulted in an ageing population; aortic valve stenosis is one of the most common acquired valvular diseases in elderly patients (>75 years) in Western countries. Once symptoms occur, the prognosis is very poor; the average survival of patients that experience angina, syncopes (faints), or heart failure symptoms due to aortic valve stenosis is only 5, 3, and 2 years, respectively.
  
  The current standard of care treatment for severe, symptomatic aortic valve stenosis is surgical aortic valve replacement (SAVR). However, one in three patients are rejected for SAVR, because of a too high operative risk. In patients with high surgical risk, Transcatheter Aortic Valve Implantation (TAVI) has been shown to be feasible (procedural success rate of 90%). TAVI involves an aortic valve implantation without open heart surgery and does not require removal of the failed native aortic valve that is causing the problems.

  This study will recruit 30 patients suffering from severe aortic stenosis in about 07 hospitals in up to 03 European countries experienced in performing TAVI procedure. Patients will be treated by implantation of a Colibri Transcatheter Aortic Heart Valve System. After implantation of the bioprosthesis, the patients will be involved in the study for 5 years with follow-up in the hospital at 30 days, 6 months, 12 months, then annually until 5 years.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  20/LO/0065

• Date of REC Opinion

  23 Apr 2020

• REC opinion

  Further Information Favourable Opinion