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Prospective Long-Term Outcomes of a Standardized Ross Procedure

Recruiting
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
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.
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Exclusion Criteria
  • Less than 18 years of age
  • Presence of active malignancy
  • Pregnant at the time of surgery
  • Inability to provide informed consent
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Survival of the patient at 1-, 5- and 10-year intervals1 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
NameTimeMethod
Rate of peri operative morbidity1 year after the procedure

Will be measured in percentage

NYHA status1 year after the procedure

Will be measured as NYHA class I, II,III, IV

Post operative infection1 year after the procedure

Measured as Yes/No

Anticoagulant usage1 year after the procedure

will be measured as Yes/No

Rate of re-hospitalization1 year after the procedure

To identify the safety of the Ross procedure measured in percentage

Rate of re-operation1 year after the procedure

Will be measured in percentage

Rate of re-intervention1 year after the procedure

will be measured in percentage

Bleeding events1 year after the procedure

Measured as Yes/No

Trial Locations

Locations (1)

Baylor Scott and White Heart Hospital

🇺🇸

Plano, Texas, United States

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