Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- blood sample
研究概览
简要总结
To investigate histological structure and molecular changes involved on the onset of AVD after left ventricular assist device (LVAD) implantation and to compare them with those of patients operated on for severe aortic regurgitation.
Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients operated on for severe aortic regurgitation are included as control. Clinical and TTE data are compiled. Samples of aortic valve are collected at the time of the intervention. RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are validated by real time qPCR in both. Blood sampling are performed pre-operatively and at one-month follow up to assess the plasma level of previously identified gene modulators. In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for validation.
Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important information for the understanding of valve remodeling and disease. ECM gene modulators could represent pertinent molecular targets to stop the progression of AVD
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Patients with long-term left-ventricular assistance awaiting transplant
- •Patients with severe aortic surgical spring deficiency
- •Major Patient
排除标准
- •Minor Patient
- •Pregnant or nursing women
- •Major under guardianship
- •People in emergencies
- •Persons not covered by the social security scheme
结局指标
主要结局
blood sample
时间窗: 24 months
RNA-sequencing analysis
次要结局
未报告次要终点
