The United States Patent Ductus Arteriosus Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Valvular Injury (Safety)
研究概览
简要总结
The objective of this study is to demonstrate the continued safety and efficacy in a real-world setting of transcatheter device closure of the PDA in premature infants less than 2kg in weight at the time of device implant using the Amplatzer Piccolo Occluder device and other devices performed in the USA.
详细描述
Based on the IMPACT registry, there are over 6000 transcatheter device closures of PDA that occurs in the United States annually. However, there are no comprehensive data collection tools for this procedure. The current databases do not include multiple data points, or follow-up data, or a section for specific adverse events to be documented. Moreover, until now, there has been no approved devices for PDA closure in children < 2kg. This clinical study is the first of its kind to collect data from all transcatheter device closure of PDA in children < 2kg performed in the USA.This study will be limited to children between 700 to 2000 grams who are the most vulnerable population undergoing this procedure. This will allow us to understand the real world experience (efficacy and safety) of using the Amplatzer Piccolo Occluder and other devices in an extremely vulnerable, yet highly underserved population. The study will allow for standardization of this procedure throughout the country for the small children (<2 kg) with a PDA. This is a multi-center, single arm, observational data collection study. This will be a large population study to help analyze outcomes in subjects <2 kg. The trial has two primary endpoints for safety and effectiveness without formal hypothesis. The safety and effectiveness results will be compared with data reported in the ADO II AS IDE and Continued Access Protocol studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 3 Days 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PDA.
- •Clinical indication for transcatheter PDA closure (discretion of the physician).
- •Weight <2 kg at the time of device implant.
排除标准
- •Weight <700 gm or greater than or equal to 2 kg at the time of device implant.
- •Age < 3 days at the time of device implant.
- •Pre-existing coarctation of the aorta.
- •Pre-existing left pulmonary artery stenosis.
- •Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension.
- •Intracardiac thrombus that interferes with device implant.
- •Active infection requiring treatment at the time of impant.
结局指标
主要结局
Valvular Injury (Safety)
时间窗: 6 months
Valvular injury includes damage to the tricuspid valve or other cardiac valve resulting in immediate post-procedural valvular dysfunction.
Pulmonary or Aortic Vessel Stenosis (Safety)
时间窗: 6 months
Adjacent vessel stenosis includes a narrowing of the aorta or the left pulmonary artery directly as a consequence of device implantation for PDA closure. Vessel stenosis could happen either during or after the procedure or delayed (\>24 hours). The outcome of vessel stenosis ranges from no intervention needed to repeated transcatheter and surgical therapies.
Rate of Effective PDA Closure (Effectiveness)
时间窗: 6 months
The effectiveness endpoint is the rate of effective closure of the PDA using a transcatheter device within six months post procedure. If more than one attempt is required, or multiple devices are required during the same procedure, it is still considered effective if there is Grade 0 or Grade 1 shunt, as defined below, at follow-up by transthoracic echocardiography or if a second procedure is not required following the initial attempt. If there is device embolization, adjacent vessel stenosis that required retrieval of the device and replacement during the same procedure with less than Grade 1 shunt during follow-up, it is still considered effective. Conversely, if an AE is noted after the procedure that requires a second procedure for treatment that results in greater than Grade 1 shunt, then the procedure is considered not effective, even if the initial attempt was effective. See protocol for PDA shunt definitions.
Vascular Access Complications (Safety)
时间窗: 6 months
Access vessel complications include femoral arterial or femoral/jugular venous complications noted during the procedure, immediately after the procedure or delayed (\>24 hours). They range from bleeding from access sites, arterial or venous thrombosis with or without the need for treatment to loss of limb secondary to arterial occlusion.
Device Embolization (Safety)
时间窗: 6 months
Device embolization includes malposition of the device either during or after the procedure or delayed (\>24 hours). The outcome of device embolization ranges from observation, transcatheter retrieval at time of procedure or at a separate time, surgical retrieval, other end organ damage, to mortality.
次要结局
- Significant obstruction of the left pulmonary artery(6 months)
- Significant obstruction of the aorta(6 months)
研究者
Shyam K. Sathanandam, MD
Associate Professor of Pediatrics, University of Tennessee. Director of Cath Lab, Le Bonheur Children's Hospital.
Le Bonheur Children's Hospital