REVIVAL Registry

• Research type

  Research Study

• Full title

  Ross for Valve replacement in Adults(REVIVAL) Registry

• IRAS ID

  270987

• Contact name

  Serban Stoica

• Contact email

  serban.stoica@uhbristol.nhs.uk

• Sponsor organisation

  Population Health Research Institute

• Clinicaltrials.gov Identifier

  NCT03894787

• Duration of Study in the UK

  10 years, 0 months, 0 days

• Research summary

  Heart valves help control blood flow through the heart and, if diseased, may need to be replaced. After having a heart valve replaced, patients have a higher risk of death than people who have not had a valve replaced. In young adult patients, replacing the aortic heart valve with a mechanical valve halves their life-span compared to other people their age. Mechanical valves tend to form blood clots so they need long-term blood thinners that increase risk of bleeding
  and lower quality of life. Animal tissue valves reduce clotting and bleeding risks but wear out sooner and shorten patient life-span. An operation, called the Ross procedure, replaces a patient’s diseased aortic valve with his/her own pulmonary valve and uses a donor valve in the pulmonary position which receives less stress than the aortic valve. The Ross procedure aims to improve valve durability with less clotting, avoiding use of blood thinners. The REVIVAL Trial is a research study investigating the efficacy and safety of the Ross procedure compared to conventional valve replacement. Specifically we are interested in learning the number of patients who survive without a life-threatening valve related complication, long term postoperatively.

  The REVIVAL Registry will be run in parallel with the Trial. Patients included in randomized trials often systematically differ from those who are not. By creating a registry of patients who are eligible for but not recruited into the REVIVAL trial, we will better understand: 1) the reasons for not including these patients; 2) how those patients differ in terms of baseline characteristics from the trial cohort; 3) whether the outcomes of registry participants differ from those in the trial, assessed by treatment group. The registry will aid in understanding the generalizability of the results that the trial produces.

• REC name

  South West - Frenchay Research Ethics Committee

• REC reference

  19/SW/0191

• Date of REC Opinion

  30 Jan 2020

• REC opinion

  Further Information Favourable Opinion