[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06352671":3,"trial-entities:NCT06352671":111,"trial-summary:NCT06352671":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":32,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":14,"eligibility_criteria":58,"std_ages":67,"locations":70,"central_contacts":93,"overall_officials":95,"references":96,"see_also_links":110},"NCT06352671","023-286","Prospective Long-Term Outcomes of a Standardized Ross Procedure","RECRUITING","2026-12-01","2026-02","2026-04-15","2023-10-12","Baylor Research Institute","OTHER",false,"This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices\u002Ftechniques for stabilization of the autograft and right ventricular outflow tract reconstruction.","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\u002Ftechniques for stabilization of the autograft and right ventricular outflow tract reconstruction.",[18],"Aortic Valve Disease",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},225,"ESTIMATED",[],[28],{"measure":29,"description":30,"timeFrame":31},"Survival of the patient","The primary endpoint of this study will be survival at 1-, 5-, and 10-year intervals.","1 year, 5 year and 10 year",[33,37,40,42,45,48,51,53],{"measure":34,"description":35,"timeFrame":36},"Rate of re-hospitalization","To identify the safety of the Ross procedure measured in percentage","1 year after the procedure",{"measure":38,"description":39,"timeFrame":36},"Rate of peri operative morbidity","Will be measured in percentage",{"measure":41,"description":39,"timeFrame":36},"Rate of re-operation",{"measure":43,"description":44,"timeFrame":36},"Rate of re-intervention","will be measured in percentage",{"measure":46,"description":47,"timeFrame":36},"NYHA status","Will be measured as NYHA class I, II,III, IV",{"measure":49,"description":50,"timeFrame":36},"Rate of Patients with Anticoagulant Usage","Rate of Patients with Anticoagulant Usage 1 year after procedure.",{"measure":52,"description":52,"timeFrame":36},"Rate of Bleeding Events",{"measure":54,"description":54,"timeFrame":36},"Rate of Post Operative Infection","ALL","18 Years","90 Years",{"inclusion":59,"exclusion":61,"raw_text":66},[60],"Patients undergoing Ross procedure at Baylor Scott and White The Heart Hospital, Plano, The University of Pennsylvania, The University of Washington, and Northwestern University.",[62,63,64,65],"Less than 18 years of age","Presence of active malignancy","Pregnant at the time of surgery","Inability to provide informed consent","Inclusion Criteria:\n\n* Patients undergoing Ross procedure at Baylor Scott and White The Heart Hospital, Plano, The University of Pennsylvania, The University of Washington, and Northwestern University.\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Presence of active malignancy\n* Pregnant at the time of surgery\n* Inability to provide informed consent",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"status":7,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":90},"Baylor Scott and White Heart Hospital","Plano","Texas","75093","United States",[78,83,87],{"name":79,"role":80,"phone":81,"email":82},"Bonnie Ostergren","CONTACT","4698144181","Bonnie.Ostergren@BSWHealth.org",{"name":84,"role":80,"phone":85,"email":86},"Sarah Hale","4698144845","sarah.hale@bswhealth.org",{"name":88,"role":89},"William Brinkman, MD","PRINCIPAL_INVESTIGATOR",{"lat":91,"lon":92},33.01984,-96.69889,[94],{"name":79,"role":80,"phone":81,"email":82},[],[97,101,104,107],{"pmid":98,"type":99,"citation":100},"33060144","BACKGROUND","Catterall F, Ames PR, Isles C. Warfarin in patients with mechanical heart valves. BMJ. 2020 Oct 15;371:m3956. doi: 10.1136\u002Fbmj.m3956. No abstract available.",{"pmid":102,"type":99,"citation":103},"35210036","El-Hamamsy I, Toyoda N, Itagaki S, Stelzer P, Varghese R, Williams EE, Erogova N, Adams DH. Propensity-Matched Comparison of the Ross Procedure and Prosthetic Aortic Valve Replacement in Adults. J Am Coll Cardiol. 2022 Mar 1;79(8):805-815. doi: 10.1016\u002Fj.jacc.2021.11.057.",{"pmid":105,"type":99,"citation":106},"27496856","Mazine A, David TE, Rao V, Hickey EJ, Christie S, Manlhiot C, Ouzounian M. Long-Term Outcomes of the Ross Procedure Versus Mechanical Aortic Valve Replacement: Propensity-Matched Cohort Study. Circulation. 2016 Aug 23;134(8):576-85. doi: 10.1161\u002FCIRCULATIONAHA.116.022800. Epub 2016 Aug 5.",{"pmid":108,"type":99,"citation":109},"33332150","Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC\u002FAHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology\u002FAmerican Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e72-e227. doi: 10.1161\u002FCIR.0000000000000923. Epub 2020 Dec 17. No abstract available.",[],{"nct_id":4,"conditions":112,"biomarkers":114},[113],"Aortic Valve Disorder",[],{"nct_id":4,"found":116,"summary":117,"prompt_version":127},true,{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an observational study, meaning researchers will watch and collect information about 225 participants who are already undergoing the Ross procedure.","completed","Long-Term Outcomes of the Ross Procedure for Aortic Valve Disease","This study is looking at the long-term results of a heart surgery called the Ross procedure (pulmonary autograft replacement) for people with aortic valve disease. The Ross procedure replaces a diseased aortic valve with a living valve from your own body. Researchers want to see how well patients do after this surgery over 1, 5, and 10 years. They are also looking for the best ways to perform this surgery. You might be able to join if you are between 18 and 90 years old and are having the Ross procedure at one of the participating hospitals. This study is currently unclear on its recruitment status.","Participants will be followed for 1, 5, and 10 years after their surgery to track their survival.",106,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]