Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 101
- 主要终点
- Primary Effectiveness End Point: Technical Success
研究概览
简要总结
The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. Subjects must meet at least one of the following:
- •Large volume left to right shunt (Qp/Qs >2:1),
- •Pulmonary hypertension (PA pressure >50% systemic) and/or
- •Clinical symptoms of congestive heart failure
- •Banding of the pulmonary artery(ies) and in the opinion of the treating investigator closure of the VSD is clinically warranted.
- •Subjects must meet at least one of the following criteria to be considered high risk for standard transatrial or transarterial surgical closure based on anatomical conditions:
- •Left ventriculotomy or an extensive right ventriculotomy,
- •Failed previous VSD closure,
- •Multiple apical and/or anterior muscular VSDs ("Swiss Cheese Septum"), and/or
- •Posterior apical VSDs covered by trabeculae.
- •Overall medical condition
- •Subject/legally authorized representative has signed the informed consent
- •Subject/legally authorized representative is willing to complete the follow-up requirements of this study
排除标准
- •Subjects with defects less than 4 mm distance from the semilunar (aortic and pulmonary) or atrioventricular valves (mitral and tricuspid)
- •Subjects with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease
- •Subjects with perimembranous (close to the aortic valve) VSD
- •Subjects with post-infarction VSD
- •Subjects who weigh < 5.2 kg
- •Subjects with sepsis (local/generalized)
- •Subjects with active bacterial infections
- •Subjects with contraindications to anti-platelets
结局指标
主要结局
Primary Effectiveness End Point: Technical Success
时间窗: During the procedure
Technical success was defined as successful deployment of the device (Amplatzer™ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD).
Primary Effectiveness End Point: Acute Procedure Success
时间窗: At the end of the procedure
Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites.
Primary Effectiveness End Point: Shunt Closure Success
时间窗: 1-year follow-up visit
Subjects in whom a defect has ≤ 2 mm residual shunt at the 1-year follow-up visit (as evaluated by the independent echocardiography board).
Primary Safety Endpoint
时间窗: Within 12 months of the procedure
The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure.
次要结局
未报告次要终点