Reduced Inflammatory Response Using Transcatheter Aortic Valve Replacement as Compared to Conventional Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 主要终点
- Generation of several inflammatory markers measured through repeated blood samples
研究概览
简要总结
A controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. Clinical outcomes are recorded and compared between the Groups. As a secondary endpoint, the inflammatory response was also compared between the patients receiving either transfemoral or trans aortal TAVI.
详细描述
18 patients admitted successively for conventional surgical aortic valve replacement and 18 patients admitted for transcatheter aortic valve implantation (TAVI) (9 transfemoral and 9 transaortic) are included.
A plasma sample is obtained at defined timepoints before, during and after surgery. At each time points the following biomarkers are analyzed:Concentrations of the complement activation products C3bc and the terminal C5b-9 complement complex (TCC), the neutrophil release product myeloperoxidase (MPO), the cytokines IL-6, eotaxin, MCP-1 and MIP-1β (12). As marker of a myocardial cellular injury troponin T levels will be analyzed. The following clinical outcomes will also be monitored: Death (in hospital, 30 day and one year), blood transfusion, stroke, myocardial infarction.
A dedicated registry will be established at the hospital according to the hospital's standard for storage of patient data. The registry will be deleted after completion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for aortic valve replacement without need for concurrent surgery
排除标准
- •known inflammatory disease and anti-inflammatory treatment
研究组 & 干预措施
Transarterial aortic valve implantation
Patients that are treated by trans arterial valve implantation (TAVI)
干预措施: Transarterial aortic valve implantation - TAVI (Procedure)
Surgical aortic valve replacement
Patients that are treated by surgical aortic valve replacement (SAVR)
干预措施: Surgical aortic valve replacement - SAVR (Procedure)
结局指标
主要结局
Generation of several inflammatory markers measured through repeated blood samples
时间窗: 24 hours
The total generation of several inflammatory markers is compared between the groups
次要结局
- Blood loss(24 hrs)
- Blood transfusion(24 hrs)
研究者
Erik Fosse
Head of Department, Professor
Oslo University Hospital