Prospective Long-Term Outcomes of a Standardized Ross Procedure
- Conditions
- Ross Procedure (Pulmonary Autograft Replacement)
- Registration Number
- NCT06352671
- Lead Sponsor
- Baylor Research Institute
- Brief 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.
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 225
- Patients undergoing Ross procedure at Baylor Scott and White The Heart Hospital, Plano, The University of Pennsylvania, The University of Washington, and Northwestern University.
- Less than 18 years of age
- Presence of active malignancy
- Pregnant at the time of surgery
- Inability to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival of the patient at 1-, 5- and 10-year intervals 1 year, 5 year and 10 year To establish a standardized Ross procedure protocol to prospectively evaluate the impact patient characteristics, operative techniques and perioperative events have on long term outcomes. The primary endpoint of this study will be survival at 1-, 5-, and 10-year intervals.
- Secondary Outcome Measures
Name Time Method Rate of peri operative morbidity 1 year after the procedure Will be measured in percentage
NYHA status 1 year after the procedure Will be measured as NYHA class I, II,III, IV
Post operative infection 1 year after the procedure Measured as Yes/No
Anticoagulant usage 1 year after the procedure will be measured as Yes/No
Rate of re-hospitalization 1 year after the procedure To identify the safety of the Ross procedure measured in percentage
Rate of re-operation 1 year after the procedure Will be measured in percentage
Rate of re-intervention 1 year after the procedure will be measured in percentage
Bleeding events 1 year after the procedure Measured as Yes/No
Trial Locations
- Locations (1)
Baylor Scott and White Heart Hospital
🇺🇸Plano, Texas, United States