Regional, Multicentric Registry of Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 529
- 试验地点
- 1
- 主要终点
- Evaluate the survival without re-intervention for aortic valve dysfunction (surgery or TAVI), after aortic root surgery with conservation of the aortic valve, according to the inclusion technique described by Tirone David
研究概览
简要总结
Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at six centers (Nantes - Rennes - Brest - Angers - Tours [two centers]). The main objective of this study is to evaluate the survival without re-intervention for aortic valve dysfunction (surgery or TAVI).
详细描述
Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David.
Inclusion criteria: Patients undergoing aortic root surgery with conservation of the aortic valve, according to the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at one of the six centers: Nantes, Rennes, Brest, Angers, Tours (two centers).
Non-inclusion criteria: Prosthetic replacement of the aortic valve intraoperatively during the first operation.
Objectives and endpoints :
- The survival without re-intervention for aortic valve dysfunction (surgery or TAVI)
- The overall cardiovascular survival
- The survival without aortic insufficiency of grade equal to or greater than two
- The survival without aortic infective endocarditis
- Assessment of long-term stroke risk Assessment of the risk of a major bleeding event in the long term Data analysis : The AORTLANTIC study is included in the EPICARD registry which is the official, national database of the French Society of Cardiac Surgery. Study data will then be collected using EPICARD's electronic Case Report Form (eCRF) and then analyzed using a multivariate Cox model. For the follow-up, the WEPI eCRF is used.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing aortic root surgery with conservation of the aortic valve, according to the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2021, at one of the six centers: Nantes, Rennes, Brest, Angers,Tours UH.
- •Non inclusion criteria :
- •Prosthetic replacement of the aortic valve intraoperatively during the first operation.
排除标准
- 未提供
结局指标
主要结局
Evaluate the survival without re-intervention for aortic valve dysfunction (surgery or TAVI), after aortic root surgery with conservation of the aortic valve, according to the inclusion technique described by Tirone David
时间窗: Conditional survival starting at 30 days
Number of patients alive without re-intervention for aortic valve dysfunction (surgery or TAVI)
次要结局
- Evaluate the overall cardiovascular survival results(up to 17 months)
- Evaluate the risk of infective endocarditis(up to 17 months)
- Evaluate the absence of aortic insufficiency greater than or equal to grade two between the two types of aortic tube graft (right prosthesis or Valsalva prosthesis)(up to 17 months)
- Evaluate the risk of stroke(up to 17 months)
- Evaluate the risk of major bleeding event(up to 17 months)