NCT06587282进行中（未招募）不适用
Multicenter, Single Arm Prospective, Non-Randomized Study Designed to Evaluate the Safety and Effectiveness of the BLOOM™ Micro-Occluder System for the Treatment of Patent Ductus Arteriosus (PDA) in Pre-mature Infants (PREEMIE)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 15
- 主要终点
- Safety Endpoint
研究概览
简要总结
This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.
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 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is age ≥5 days at time of enrollment.
- •Subject has a diagnosis of a hemodynamically significant patent ductus arteriosus (PDA) requiring closure.
- •Subject has a PDA is ≤4.0 mm in diameter.
- •Subject has a PDA is ≥5 mm in length.
- •Subject's weight is between 600-2500 grams at time of enrollment.
排除标准
- •Subject has pre-existing coarctation of the aorta.
- •Subject has pre-existing left pulmonary artery stenosis.
- •Subject has an Intracardiac thrombus that may interfere with the implant procedure
- •Subject has other known hemodynamically significant congenital heart disease conditions at time of enrollment requiring intervention
- •Subject has an active systemic infection at the time of enrollment.
研究组 & 干预措施
PDA treatment
Experimental
PDA treated with Bloom Micro Occluder System
干预措施: Bloom Micro Occluder System (Device)
结局指标
主要结局
Safety Endpoint
时间窗: 30 days
Composite rate of device-related Major Adverse Events (MAE) of interest through 30 days following the index procedure.
Effectiveness Endpoint
时间窗: 6 Months
The rate of Clinical Success achieved at the 6-month follow-up visit.
次要结局
未报告次要终点
研究者
研究点 (15)
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