NCT04105595进行中（未招募）不适用
Multi Centre, International, Post Market Registry to Monitor the Clinical Performance and Safety of an Atrial Septal Closure Device With Bioresorbable Framework in Patients With Clinically Significant Atrial Septum Defect (ASD) or Patent Foramen Ovale (PFO) in Routine Clinical Use
atHeart Medical1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年3月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Effective closure by echocardiography
研究概览
简要总结
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO) in routine clinical use
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffers from ASD (including ostium secundum ASD or a fenestration from a Fontan procedure) or PFO and is planned to receive the CBSO.
- •Patient (or legal guardian) has been informed and agreed to and signed the informed consent form.
- •A CBSO is implanted into the patient.
排除标准
- •Patient is known to have one or more of the contraindications listed in the instructions for use.
- •Patient is currently participating in one or more interventional studies, with exception of a study investigating the CBSO.
- •Patient is implanted with another product in the atrial septum.
结局指标
主要结局
Effective closure by echocardiography
时间窗: at 6 months
Safety throughout the follow up duration by absence of serious incidents
时间窗: day 0 to 3 years
次要结局
未报告次要终点
研究者
研究点 (1)
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