Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
A sample of plasma and whole blood will be obtained at 4 time points (pre-procedural, early post-procedural, at hospital discharge and during an eventual visite at 3 or 6 months post-procedural). Test for platelet reactivity (LTA, light transmittance aggregometry and Elisa PRI, Platelet reactivity index), multimeric VWF (von Willebrand factor) and blood level of NET: neutrophil extracellular traps(flow cytometry and ELISA) analyses will be performed at the time of blood sampling. Aliquots of plasma will be stored and frozen for further analyses
详细描述
There are two major objectives:
- To correlate changes in VWF, platelet reactivity and blood level of NET after TAVR with clinical outcomes
- To correlate changes in VWF, platelet reactivity and blood level of NET with antithrombotic regimens after TAVR (direct anticoagulants apixaban versus standard of care, ie Vitamin K antagonist or antiplatelet therapy).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient undergoing TAVR intervention
- •agreement given
排除标准
- •severe thrombopenia ( <40.10^9/L)
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: 12 months
stroke/transient ischemic attack; acute coronary syndrome; hospitalization for cardiac insufficiency, cardiovascular or unexplained deaths will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician
Bleeding
时间窗: 12 months
Serious bleeding event (BLEED II or more) will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician
次要结局
- mean pressure transprosthetic gradient(within ten days after valve replacement)