Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352671
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Brief Title:
Prospective Long-Term Outcomes of a Standardized Ross Procedure
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
Official Title:
Prospective Long-Term Outcomes of a Standardized Ross Procedure
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROSS
Brief Summary:
This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practicestechniques for stabilization of the autograft and right ventricular outflow tract reconstruction
Detailed 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 2018722761-77 This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practicestechniques for stabilization of the autograft and right ventricular outflow tract reconstruction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None