The U.S. PDA Registry
ConditionDuctus Arteriosus, Patent
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-1
SponsorLe Bonheur Children's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of PDA.
Clinical indication for transcatheter PDA closure (discretion of the physician).
Weight <2 kg at the time of device implant.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Transcatheter PDA Closure
Treatment groups
5,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Le Bonheur Children's Hospital
Lead sponsor
Abbott
Collaborator
Source ClinicalTrials.gov