Ross for Valve Replacement in Adults - Registry
Condition: Aortic Valve Disease
MeSH terms: Aortic Valve Disease
Study type: Observational [Patient Registry]

Summary: 
      This registry follows patients undergoing two methods of aortic heart valve replacement in
      adults aged 18-60, the Ross procedure or conventional aortic valve replacement using a
      biologic or mechanical heart valve. 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. 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. The REVIVAL Registry will run in parallel with the REVIVAL randomized
      trial.
    

Detailed description: 
      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. Patients and physicians need a large, high-quality study comparing the
      Ross procedure and standard valve replacement to know if either approach is better. In
      parallel to the REVIVAL Registry, a REVIVAL Randomized Trial will also take place.

      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, the investigators 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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who meet eligibility criteria of the REVIVAL trial, but are not included in
        the trial due to patient or clinician factors, will be asked to participate in the REVIVAL
        registry.
      
Keywords: Ross procedure; Conventional aortic valve replacement