The U.S. PDA Registry for Premature Infants
This observational study, called The U.S. PDA Registry, is looking at the continued safety and effectiveness of using devices like the Amplatzer Piccolo Occluder to close a patent ductus arteriosus (PDA) in premature infants. A PDA is an open blood vessel that normally closes shortly after birth. This study is specifically for infants who weigh less than 2 kilograms (about 4.4 pounds) at the time of the procedure. Researchers will collect data on how well these devices work and any problems that might occur, such as issues with blood vessel access, heart valve injury, or the device moving out of place. The goal is to gather real-world information to help standardize this procedure for very small infants. The study is currently ongoing and aims to enroll 5000 participants.
- Study design
- This is an observational study, meaning researchers will collect data without assigning treatments. It is a single-arm study, involving about 5000 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety outcomes like vascular access complications, valvular injury, and device embolization for 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The U.S. PDA Registry
At a glance
Conditions
NCT04205877
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
LeBonheur Children's Hospital
Memphis, Tennesseestudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Shyam Sathanandam, MD · PRINCIPAL_INVESTIGATOR · National Principal Investigator
Who to contact
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What this trial measures
- Vascular Access Complications (Safety)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.
- Valvular Injury (Safety)6 months
Valvular injury includes damage to the tricuspid valve or other cardiac valve resulting in immediate post-procedural valvular dysfunction.
- Device Embolization (Safety)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.
- Pulmonary or Aortic Vessel Stenosis (Safety)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)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.