Baylor Scott and White Heart Hospital
Plano, Texas, 75093, United States
Location status: Recruiting
Location contact
Bonnie Ostergren
CONTACT
Sarah Hale
CONTACT
William Brinkman, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06352671
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Plano, Texas, 75093, United States
Location status: Recruiting
Bonnie Ostergren
CONTACT
Sarah Hale
CONTACT
William Brinkman, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 year after the procedure
To identify the safety of the Ross procedure measured in percentage
Time frame: 1 year after the procedure
Will be measured in percentage
Time frame: 1 year after the procedure
Will be measured in percentage
Time frame: 1 year after the procedure
will be measured in percentage
Time frame: 1 year after the procedure
Will be measured as NYHA class I, II,III, IV
Time frame: 1 year after the procedure
Rate of Patients with Anticoagulant Usage 1 year after procedure.
Time frame: 1 year after the procedure
Rate of Bleeding Events
Time frame: 1 year after the procedure
Rate of Post Operative Infection
Contact information is provided by the study sponsor or research team.
Baylor Research Institute
Other
Acronym: ROSS
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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