AMPLATZER Duct Occluder II Additional Sizes Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant
研究概览
简要总结
The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance.
To account for subject dropout, up to 50 subjects will be enrolled in this clinical investigation. Up to an additional 150 subjects may be enrolled under continued access. The clinical investigation will be conducted at up to 10 centers in the United States.
Subjects participating in this clinical investigation will be followed for 3 years. The expected duration of enrollment is 18 months. The total duration of the clinical investigation is expected to be 4.5 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
- 3 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a PDA
- •PDA ≤ 4mm in diameter
- •PDA ≥ 3mm in length
- •Subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study
- •NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent
排除标准
- •Weight < 700 grams at time of the procedure
- •Age < 3 days at time of procedure
- •Coarctation of the aorta
- •Left pulmonary artery stenosis
- •Cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension
- •Intracardiac thrombus
- •Active infection requiring treatment at the time of implant
- •Female subjects of child bearing potential are either pregnant or desire to become pregnant within six months post implant
- •Other disease process likely to limit survival to less than six (6) months
- •Participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints
结局指标
主要结局
Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant
时间窗: At the 6-month follow-up
The primary effectiveness endpoint is the rate of effective closure of the ductus arteriosus among subjects with a successful ADO II AS implant as assessed by the presence of either a Grade 0 (none) or Grade 1 (trivial) shunt at the 6-month follow-up by transthoracic echocardiography (TTE).
Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant
时间窗: Through 180 days
Major complications are defined as device (ADO II AS) or procedure-related adverse events resulting in any of the following: * death, * life-threatening adverse event, * persistent or significant disability/incapacity, and/or * a major open surgical intervention which is performed by a surgeon under general anesthesia
次要结局
- The Rate of Significant Obstruction of the Pulmonary Artery or Aorta(Through 6 month follow-up visit)