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Clinical Trial Summary

This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction.


Clinical Trial Description

The optimal approach for aortic valve replacement in adults with an anticipated life expectancy greater than fifteen years remains unclear. Mechanical and bioprosthetic valves, while often used, have specific downfalls. Mechanical valves require lifelong anticoagulation usage and bioprosthetic tissue valves have a limited lifespan. The Ross procedure (pulmonary autograft replacement) is the only operation which replaces the diseased aortic valve with a living substitute. Concerns over increased surgical risk and potential long-term failure have shown decreased use of this procedure. However, recent publications from expert centers have shown, in the current era the Ross procedure can be reliably performed safely and reproducibly in selected patients. Furthermore, an increasing body of evidence suggests the Ross procedure is associated with better long-term outcomes compared with conventional aortic valve replacement (AVR) in young and middle-aged adults (jamc 2018,72:2761-77. This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction. ;


Study Design


NCT number NCT06352671
Study type Observational
Source Baylor Research Institute
Contact Rincy Rajan
Phone 4698144981
Email Rincy.Rajan@BSWHealth.org
Status Recruiting
Phase
Start date October 12, 2023
Completion date January 1, 2026