NCT00688571已完成不适用
Melody TPV Post-Market Surveillance Study
Medtronic Bakken Research Center14 个研究点 分布在 6 个国家目标入组 63 人开始时间: 2007年10月1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
- 63
- 试验地点
- 14
- 主要终点
- Clinical Performance over five years. Freedom from the following events: * explant * reintervention * stent fracture * valve dysfunction * device or procedure related death
研究概览
简要总结
This non-randomized, prospective, interventional observational multi-center study is designed to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary Valve (TPV) in the post market environment over a period of five years after transcatheter implantation in patients with dysfunctional RVOT conduits. In addition, the quality of life of implanted subjects will be assessed over five years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prospective subjects have complex congenital heart defects that have been palliated with RVOT conduits that have become dysfunctional and have a clinical indication for invasive intervention. Prospective subjects must meet all of following inclusion and
排除标准
- •Inclusion Criteria:
- •Age greater than or equal to 5 years of age
- •Weight greater than or equal to 30 kilograms
- •Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
- •Any of the following by transthoracic echocardiography
- •For patients in NYHA Classification II, III, or IV:
- •Moderate (3+) or severe (4+) pulmonary regurgitation, or
- •Mean RVOT gradient greater than or equal to 35 mmHg.
- •For patients in NYHA Classification I:
- •Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction, or
- •Mean RVOT gradient greater than or equal to 40 mmHg.
- •Exclusion Criteria:
- •Active endocarditis
- •A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
- •Patient or - for patients who cannot legally give consent themselves- the guardian unwilling or unable to provide written informed consent or comply with follow-up requirements
- •Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein
- •Known intravenous drug abuse
结局指标
主要结局
Clinical Performance over five years. Freedom from the following events: * explant * reintervention * stent fracture * valve dysfunction * device or procedure related death
时间窗: August 2014
次要结局
- Procedural success(August 2014)
- Hemodynamic Performance(August 2014)
- Incidence of device and procedure related adverse events(August 2014)
研究者
研究点 (14)
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