Trifecta and Epic VinV Registry

• Research type

  Research Study

• Full title

  The International Trifecta and Epic Valve-in-Valve Registry: Detailed Insights into Management Strategies and Outcomes

• IRAS ID

  315651

• Contact name

  Sunil K. Ohri

• Contact email

  Sunil.ohri@uhs.nhs.uk

• Sponsor organisation

  Helios Health Institute GmbH

• Clinicaltrials.gov Identifier

  NCT05389631, ClinicalTrials.gov-Registration

• Duration of Study in the UK

  0 years, 6 months, 31 days

• Research summary

  This is a retrospective registry collecting information about patients who have had conventional aortic valve replacement surgery with a Trifecta or Epic heart valve [two of many models available]. These patients have then gone on to have a valve-in-valve implantation.
  Valve-in-valve implantation: due to the natural ageing of the original implanted valve [structural degeneration] the patient may require further intervention. In some patients, re-do aortic valve surgery is not feasible or desirable. It is possible to implant a valve within the existing artificial heart valve using a long narrow tube called a catheter [trans-catheter aortic valve-in-valve implantation (V-in-V TAVI)]. This procedure is usually favoured for patients in their later years of life, up until their eighties or nineties.

  The questions we would like to answer are:
  • Are there factors that predict the safety and efficacy of V-in-V TAVI in patients who have previously received a Trifecta or Epic heart valve?
  • Can we identify preoperative risk factors for major complications in both the short term [days] and long term [years] after the V-in-V TAVI?
  • Do different treatment strategies influence outcomes?
  • Can protective measures prevent complications from happening for future patients having this combination of procedures?

  Data will be collected from hospitals of several European countries (Germany, UK, France, The Netherlands and Belgium) which have treated a large number of these patients. Implantations until June 2020 will be taken into account. Data collection is expected to approximately last four months. This research will be supported by Abbott GmbH & Co.

• REC name

  North of Scotland Research Ethics Committee 2

• REC reference

  22/NS/0122

• Date of REC Opinion

  26 Aug 2022

• REC opinion

  Favourable Opinion