NCT04241328招募中不适用
SYMBIOSIS Post-Market Registry
Medtronic Cardiac Surgery27 个研究点 分布在 8 个国家目标入组 5,000 人开始时间: 2020年1月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 27
- 主要终点
- Device Safety
研究概览
简要总结
The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.
详细描述
The objective is to collect product safety and performance data for Medtronic CE (Conformitè Europëenne )-Marked Cardiac Surgery, including perfusion (CS) products.
The main goals of this data collection are as follows:
- Identification of any (new) device-related complications including events which were not anticipated or documented in the Instructions For Use (IFU), or Risk Management Plan, or Clinical Evidence Evaluation report, or Design Failure Modes and Effect Analysis
- Evaluation of device success defined as the absence of any probable or causal device-related adverse events or device deficiencies
- Evaluation of general device performance when applicable
Subjects are enrolled and, if applicable, followed according to routine care practices at their treating hospital.
Inclusion Criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating registry hospital.
- •Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used.
排除标准
- •Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry
结局指标
主要结局
Device Safety
时间窗: Procedural
Procedure- , device-related events and device deficiencies
Device performance
时间窗: Procedural
Device Success
次要结局
未报告次要终点
研究者
研究点 (27)
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