Ross for Valve replacement in AduLts (ReVIvAL)
In the REVIVAL pilot trial, we are asking: Is it feasible to conduct a large randomized controlled trial (RCT) evaluating the efficacy and safety of the Ross procedure compared to conventional aortic valve replacement (AVR)? Specifically, can participating centres recruit an average of 6 patients per year using the expertise-based RCT protocol we have developed with acceptable compliance to allocation?
In patients undergoing AVR for the treatment of aortic valve disease, does the Ross procedure result in superior outcomes when compared to conventional AVR techniques, including stented or stentless bioprostheses and mechanical aortic valves, with respect to survival free of life-threatening valve-related complications (life-threatening bleeding, systemic thromboembolism, valve thrombosis, and operated-on valve re-intervention) within the first eight years post-operatively?
An international multicenter trial of surgical AVR in 1047 young adults (18-60 years of age) undergoing the Ross procedure versus one of the alternative approaches (mechanical versus bioprosthesis versus stentless porcine root) with expertise-based randomization.
The outcome measures of the pilot phase, in order of importance, are: 1) To evaluate the capacity to enroll a mean of 6 patients per year per center; 2) To validate the assumption of greater than 90% compliance with allocation; 3) To validate the proportion of mechanical (65%) versus biological (35%) valves in the conventional arm.
Richard Whitlock, Emilie Belley-Coté, Ismail El-Hamamsy