NCT03286088已完成不适用
Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
Philips Electronics Nederland B.V. acting through Philips CTO organization2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年8月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Central diastolic and systolic blood pressures
研究概览
简要总结
The study primarily aims to collect standard of care clinical data in a wide spectrum of simple to complex mitral valve regurgitation (MVR) cases to validate a post-processing stand-alone software prototype (QFlow), developed by Philips Research Paris (Medisys).
Investigator does not intervene in the care of the patient, but simply collects standard of care images and measurements that are needed for the validation of the investigational software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both genders
- •age between 18 and 85 years old (adult, senior)
- •sinus rhythm
- •hHemodynamic stable
- •mitral valve regurgitation (MVR) of any grade i.e., from mild to severe as determined by assessment of a qualifying TransThoracic Echocardiography (TTE) exam at Saint-Luc University Hospital
- •scheduled for TransEsophageal Echocardiography (TEE) at Saint-Luc University Hospital, as part of the subject's routine standard of care
- •subjects has functional capacity to give written informed consent
排除标准
- •pregnancy
- •subject lacks functional capacity to give written informed consent belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures
- •Among the120 subjects, there will be three (3) sub-groups as follows:
- •a first sub-group (A) of 50 subjects with all inclusion criteria and none of the exclusion criteria
- •a second sub-group (B) of 50 subjects with additional inclusion criterion: scheduled for cardiac Magnetic Resonance (cMR), as part of the subject's routine standard of care
- •a third sub-group (C) of 20 subjects with additional inclusion criterion: scheduled for MitraClip transcatheter mitral valve repair (MitraClip) procedure as part of the subject's routine standard of care
结局指标
主要结局
Central diastolic and systolic blood pressures
时间窗: Day 1
images and measurements
次要结局
未报告次要终点
研究者
研究点 (2)
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