NCT02220270Unknown不适用
A Prospective, Multi-center Study to Evaluate the Safety and Performance of the Hyperion™ ASD and PDA Closure Systems.
European Cardiovascular Research Center10 个研究点 分布在 4 个国家目标入组 200 人开始时间: 2015年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Success of implantation
研究概览
简要总结
The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD and PDA patients.
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
- 1 Year 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has ASD or PDA documented by a Transoesophagial echocardiography (TEE) or a Transthoracic echocardiography (TTE) and indication for closure that is amenable to treatment with the Hyperion™ ASD or PDA occluder
- •For PDA: Patient age ≥ 1 year old
- •For ASD: Patient weighting ≥15 kg of any age
- •Patient is willing and able to comply with specified follow-up evaluations
- •Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written Notice of Informed Consent, approved by the appropriate Ethics Committee (EC)
排除标准
- •Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test
- •Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year)
- •Patient has a known hypersensitivity or contraindication to aspirin, heparin, and/or contrast sensitivity that cannot be adequately pre-medicated
- •Currently participating in another clinical study
- •Active endocarditis, active bacterial infection, or other infection producing bacteremia or sepsis
- •Congenital or structural heart disease other than ASD or PDA
- •Thrombus at the intended site of implant or documented venous thrombosis in venous access
- •Severe pulmonary hypertension
- •Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction
- •ASD or PDA anatomy non suitable for the Hyperion™ closure device
- •Confinement to bed (increased risk for clot formation)
- •Prior cardiac implantation of cardiac devices for ASD or PDA closure
结局指标
主要结局
Success of implantation
时间窗: 30 days
Success of implantation without death, stroke, any device embolization, puncture site bleeding requiring surgical repair or blood transfusion and without any other device or procedure related MAE at 30 days
Device success
时间窗: 6 months
Device success defined as ASD or PDA closure at 6 months post procedure by a Transthoracic echocardiography (TTE) or a Transesophageal echocardiography (TEE).
次要结局
- Major Adverse Events(30 days, 6 and 12 months)
- Procedure success(6 months)
研究者
研究点 (10)
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