VIRTU-3

• Research type

  Research Study

• Full title

  A prototype tool to calculate virtual myocardial fractional flow reserve (FFR) non-invasivley (VIRTU-3)

• IRAS ID

  228348

• Contact name

  Julian Gunn

• Contact email

  j.gunn@sheffield.ac.uk

• Sponsor organisation

  Sheffield Teaching Hospitals NHS Foundation Trust

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  Summary of Research
  To create a prototype ‘virtual’ (computerised) FFR software tool (VIRTUheart™ Mk 3) prototype that is suitable to promote to the large equipment manufacturers and seek partner(s) to develop medical grade device classification grade III software package according to appropriate ISO standards that could, subject to MHRA approval, then be used in a future clinical trial(s).\nWe aim to develop the software further by using clinical data from patients undergoing routine PCI procedures in Sheffield Teaching Hospitals. We will collect the routine data and input this into the virtual tool. No follow ups are required from the participants only their routine clinical data relating to their procedure to further validate the tool with the aim of progressing this into clinical practice in the future.\n\n

  Summary of Results
  Background:
  For patients with heart trouble due to narrowings of their arteries, specialists take X ray pictures to decide whether to treat. But looking at the pictures is not accurate. It is better to measure the pressure gradient across each narrowing with a probe, but this is not used much. So we developed a method of reconstructing coronary arteries in a computer, using software to calculate the blood flow. This work was at the stage of a rough-and-ready research tool.
  Key findings:
  We improved the mathematics and included some clinical information to make it accurate. We made the software intuitive to use by an NHS worker, and tested this in ‘expert panels’. We then found a suitable company and expect to complete an agreement with them.
  Conclusions and future plans:
  We have upgraded our VIRTUheartTM tool to include the latest software, made the interface user-friendly, tested it with the help of an expert panel, and are about to commercialise it.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  17/SC/0309

• Date of REC Opinion

  19 Jun 2017

• REC opinion

  Favourable Opinion