Ross for Valve Replacement in AduLts Trial
Condition: Aortic Valve Disease
MeSH terms: Aortic Valve Disease
Study type: Interventional

Summary: 
      This study evaluates two methods of aortic heart valve replacement in adults aged 18-60, the
      Ross procedure versus 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.
    

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.

      The investigators will perform a 3-year feasibility study in seven sites, in Canada and
      abroad, to test the study design and ability to do a larger, conclusive study comparing the
      impact of the Ross procedure to standard valve replacement on survival without valve-related
      life-threatening complications. Patients will be randomized, like flipping a coin, to receive
      the Ross or standard valve surgery. The goals are 1) to evaluate if the investigators can
      recruit 6 patients per site per year, 2) to test if the assigned procedure is performed in
      over 90% of study patients, and 3) to see how many mechanical vs. tissue valves are used in
      the standard valve group. Patients eligible but not enrolled in the trial will be asked if
      the investigators can collect some data on how they do after their surgery. If the
      investigators show the study is feasible, they will proceed to the full study and will
      include the feasibility patients in the full study.
    

Intervention name(s): Ross procedure; Conventional aortic valve replacement
Intervention type(s): Procedure; Procedure
Intervention description(s): The patient will undergo the Ross procedure where the surgeon will replace the aortic valve using a pulmonary autograft (Ross procedure) with pulmonary homograft replacement of the pulmonary root. Identified Ross experts will perform all Ross procedures.; The patient will undergo Conventional aortic valve replacement where the surgeon will replace the aortic valve with another prosthesis which can include a mechanical prosthesis, a stented biological prosthesis, a stentless biological valve or root, or a catheter valve.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiac surgery; Aortic valve replacement; Ross procedure