Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Occurence of major access site vascular complications
研究概览
简要总结
The percutaneous MANTA Vascular Closure Device is dedicated to the closure of large bore arteriotomies. It appears to be a safe and doable option for vascular access closure in patients undergoing transfemoral Transcatheter Aortic Valve Implantation. Data concerning safety and efficacy of MANTA Vascular Closure Device in Minimally Invasive Cardiac Surgery are scarce. This study aim to assess this novel collagen-based technology in minimal invasive aortic valve replacement surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Subject voluntarily agreeing to participate in the study
- •Subject >= 18 years of age
- •Patients operated between december 16, 2019 and june 30, 2021 from minimally invasive cardiac surgery with femoral cannulation for cardiopulmonary bypass in Dijon University Hospital
- •Patients in whom the MANTA device has been used for femoral artery closure
排除标准
- •Not applicable
结局指标
主要结局
Occurence of major access site vascular complications
时间窗: 30 days
according to the Valve Academic Research Consortium (VARC)-2 and Bleeding Academic Research Consortium (BARC)-2 definition criteria in postoperative period
Hemostasis success
时间窗: 10 min
Hemostasis at the puncture site of cutting the MANTA suture without need for manual or mechanical compression and without late re-bleeding
次要结局
未报告次要终点