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NCT Number: NCT06352671

Prospective Long-Term Outcomes of a Standardized Ross Procedure

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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Rate of re-hospitalization

    Time frame: 1 year after the procedure

    To identify the safety of the Ross procedure measured in percentage

  2. Rate of peri operative morbidity

    Time frame: 1 year after the procedure

    Will be measured in percentage

  3. Rate of re-operation

    Time frame: 1 year after the procedure

    Will be measured in percentage

  4. Rate of re-intervention

    Time frame: 1 year after the procedure

    will be measured in percentage

  5. NYHA status

    Time frame: 1 year after the procedure

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

  6. Rate of Patients with Anticoagulant Usage

    Time frame: 1 year after the procedure

    Rate of Patients with Anticoagulant Usage 1 year after procedure.

  7. Rate of Bleeding Events

    Time frame: 1 year after the procedure

    Rate of Bleeding Events

  8. Rate of Post Operative Infection

    Time frame: 1 year after the procedure

    Rate of Post Operative Infection

Study contacts

Contact information is provided by the study sponsor or research team.

Bonnie Ostergren

CONTACT

[email protected]

4698144181

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Acronym: ROSS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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