Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 10
- 主要终点
- Time to Hemostasis
研究概览
简要总结
This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures. The study will enroll participants who are undergoing a TAVR procedure. The purpose of this study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.
详细描述
In the U.S. and Canada, the MANTA® Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures. In Israel, the 14F MANTA® is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA® device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F). The purpose of the study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.
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
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidate meets criteria for on-label use of MANTA® VCD as specified in the country-specific MANTA® VCD Instructions for Use (IFU), per judgement of the investigator.
- •Age ≥21 years
排除标准
- •Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.
结局指标
主要结局
Time to Hemostasis
时间窗: During the procedure
The elapsed time between MANTA® deployment and first observed and confirmed arterial hemostasis
Rate of VARC-3 Major & Minor Vascular complications
时间窗: within 30 days of TAVR procedure
次要结局
- Ambulation Success:(During procedure admission)
- Treatment Success:(within 30 days of TAVR procedure)
- Technical Success:(During the procedure)
- Additional interventions: Required at large bore access site to address complications(within 30 days following the procedure)
