AssessmenTs of ThRombogenicity for trAnsCatheter aorTIc valVE Implantation by Total Thrombus-formation Analysis System (ATTRACTIVE-TTAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI
研究概览
简要总结
Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI compared to those in surgical aortic valve replacement, those in TAVI still remains high. In addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach. The antithrombotic regimen in patients undergoing TAVI is needed to be established.
To establish the antithrombotic regimen in patients undergoing TAVI,
- the investigators assess the changes in platelet thrombus formation and white thrombus formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis System (T-TAS).
- the investigators analyze plasma microRNAs, and shear stress by using computational fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.
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
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •twenty years and older
- •with the informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)
排除标准
- •withdrawn the informed consent
- •patients with trans-apical approach
- •critical illness condition (severe infectious disease, cancer, severe bleeding disorder)
- •transition to the surgical AVR
结局指标
主要结局
Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI
时间窗: pre-, day 2, day 7, 1 month after device implantation
To measure the thrombus formation area under the curve for AR-chip (AR10-AUC30), and PL-chip (PL24-AUC10) before and after TAVI.
次要结局
- Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.(within 30 days after device implantation)
- Changes in shear stress analyzed by using CFD analysis of contrast-enhanced CT(pre-, day 7 after device implantation)
- Changes in von Willebrand factor multimer decrease(pre-, day 2 after device implantation)
研究者
Kenichi Tsujita, MD, PhD
Professor of Cardiovascular Medicine, Principal Investigator
Kumamoto University