PROGRESS PVL Registry (2016-02)

• Research type

  Research Study

• Full title

  PRospective Observation of aortic reGuRgitation aftEr TAVI and progreSS over time: PROGRESS PVL Registry

• IRAS ID

  240837

• Contact name

  Jan Kovac

• Contact email

  jan.kovac@uhl-tr.nhs.uk

• Sponsor organisation

  Symetis SA

• Clinicaltrials.gov Identifier

  NCT02987894

• Duration of Study in the UK

  1 years, 10 months, 31 days

• Research summary

  This is an observational study to further evaluate safety and performance of the ACURATE neo™ Aortic bio-prosthesis (a biosynthetic heart valve) which is approved to treat patients with severe aortic stenosis. Only patients who are eligible under the standard of care for transcatheter Aortic Valve Implantation (TAVI) with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use will be able to participate in the study.
  Approximately 500 patients are expected to take part in the study at up to 40 study centres in Europe, North America and South America.

  Patient’s participation will last for approximately 12 months and will be considered complete after the 1-year follow-up visit.

  The study is divided into three periods:
  1. Screening period – patient will undergo the consent process and if decides to participate will be required to sign the consent form. The study doctor will check if patient meets the eligibility criteria and can take part in the study.
  2. Implantation of the ACURATE neo™ device procedure.
  3. Follow-up period – the study doctor will collect required study data at the point of patient’s discharge from the hospital or 7 days after the implantation of device procedure (whichever occurs first) and during patient’s follow up visits which will take place 30 days after the procedure and 12 months after the procedure.

  Data will only be collected during patient’s routine ACURATE neo™ check-ups that patient would have whether he/she is in this study or not. There will be no additional hospital visits required due to patient participation in the study.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  18/ES/0013

• Date of REC Opinion

  29 Jan 2018

• REC opinion

  Favourable Opinion