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临床试验/NCT06352671
NCT06352671招募中不适用

Prospective Long-Term Outcomes of a Standardized Ross Procedure

Baylor Research Institute2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2023年10月12日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
225
试验地点
2
主要终点
Survival of the patient

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing Ross procedure at Baylor Scott and White The Heart Hospital, Plano, The University of Pennsylvania, The University of Washington, and Northwestern University.

排除标准

  • Less than 18 years of age
  • Presence of active malignancy
  • Pregnant at the time of surgery
  • Inability to provide informed consent

结局指标

主要结局

Survival of the patient

时间窗: 1 year, 5 year and 10 year

The primary endpoint of this study will be survival at 1-, 5-, and 10-year intervals.

次要结局

  • Rate of re-hospitalization(1 year after the procedure)
  • Rate of peri operative morbidity(1 year after the procedure)
  • Rate of re-operation(1 year after the procedure)
  • Rate of re-intervention(1 year after the procedure)
  • NYHA status(1 year after the procedure)
  • Rate of re-hospitalization(1 year after the procedure)
  • Rate of peri operative morbidity(1 year after the procedure)
  • Rate of re-operation(1 year after the procedure)
  • Rate of re-intervention(1 year after the procedure)
  • NYHA status(1 year after the procedure)
  • Rate of Bleeding Events(1 year after the procedure)
  • Rate of Patients with Anticoagulant Usage(1 year after the procedure)
  • Rate of Post Operative Infection(1 year after the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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