Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Procedural success
研究概览
简要总结
This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.
详细描述
This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety of a guide wire conditional for use in magnetic resonance imaging and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.
The guidewire is used to access the patients central circulatory system and in particular for the introduction and exact placement of a pressure catheter to measure the pressure gradient over the aortic arch. The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.Patients need to have a body weight over 40 kg and the introduction of a 5 French catheter should be possible. The primary endpoint is the measurement of procedural success, defined as successful insertion, steerability and visibility in MRI, in the absence of device related adverse events such as damage to vessel wall. In addition structural integrity of the instruments is to be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with clinical indication for cardiac magnetic resonance and conventional diagnostic catheterisation
- •patients with body weight of > 40 kg in which the introduction of an introducer of > 5 French is possible.
- •subject provided written informed consent using the approved consent form or in case of a minor the subject provided written assent and its legal guardian provided written informed consent.
排除标准
- •major surgery in the last 42 days
- •history of irreversible bleeding disorder
- •contraindication to cardiac magnetic resonance
- •Contraindications to guidewire procedures, such as evidence of active infection
- •women of child-bearing potential who cannot provide a negative pregnancy test
- •chronic total occlusion.
研究组 & 干预措施
pressure gradient measurement
Diagnostic procedure to measure pressure gradient in series of patients. Focus is on safety and absence of adverse events
干预措施: pressure gradient measurement (Procedure)
pressure gradient measurement
Diagnostic procedure to measure pressure gradient in series of patients. Focus is on safety and absence of adverse events
干预措施: MRWire (Device)
结局指标
主要结局
Procedural success
时间窗: Up to 30 days after procedure
procedural success means that insertion, steerability and visibility of the guide wire in the MR guided intervention was successfully reached, in the absence of adverse events up to 30 days after procedure
次要结局
未报告次要终点