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Prospective Long-Term Outcomes of a Standardized Ross Procedure (ROSS)

Baylor Scott and White Health (BSWH) logo

Baylor Scott and White Health (BSWH)

Status

Enrolling

Conditions

Aortic Valve Disease

Study type

Observational

Funder types

Other

Identifiers

NCT06352671
023-286

Details and patient eligibility

About

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.

Full 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.

Enrollment

225 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Bonnie Ostergren

Data sourced from clinicaltrials.gov

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