Prospective Long-Term Outcomes of a Standardized Ross Procedure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Baylor Research Institute
- Enrollment
- 225
- Locations
- 2
- Primary Endpoint
- Survival of the patient
Study Overview
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. 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing Ross procedure at Baylor Scott and White The Heart Hospital, Plano, The University of Pennsylvania, The University of Washington, and Northwestern University.
Exclusion Criteria
- •Less than 18 years of age
- •Presence of active malignancy
- •Pregnant at the time of surgery
- •Inability to provide informed consent
Outcomes
Primary Outcomes
Survival of the patient
Time Frame: 1 year, 5 year and 10 year
The primary endpoint of this study will be survival at 1-, 5-, and 10-year intervals.
Secondary Outcomes
- Rate of re-hospitalization(1 year after the procedure)
- Rate of peri operative morbidity(1 year after the procedure)
- Rate of re-operation(1 year after the procedure)
- Rate of re-intervention(1 year after the procedure)
- NYHA status(1 year after the procedure)
- Rate of re-hospitalization(1 year after the procedure)
- Rate of peri operative morbidity(1 year after the procedure)
- Rate of re-operation(1 year after the procedure)
- Rate of re-intervention(1 year after the procedure)
- NYHA status(1 year after the procedure)
- Rate of Bleeding Events(1 year after the procedure)
- Rate of Patients with Anticoagulant Usage(1 year after the procedure)
- Rate of Post Operative Infection(1 year after the procedure)