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
This trial does not accept healthy volunteersQualifiers
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 population
The study population is patients with diagnosis of PDA with clinical indication for transcatheter PDA closure, and weigh less than 2 kg at the time of device implant.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Transcatheter PDA Closure
DeviceDevice utilized for closure of PDA, study is to help assure continued safety and effectiveness of FDA approved Amplatzer Piccolo Occluder device as well as other devices used off label for PDA closure in premature infants less than 2 kg at the time of device implant.
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: Registry Group1 intervention
Trial outcomes
Primary outcomes
1
Vascular Access Complications (Safety)
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.
Time frame
6 months2
Valvular Injury (Safety)
Valvular injury includes damage to the tricuspid valve or other cardiac valve resulting in immediate post-procedural valvular dysfunction.
Time frame
6 months3
Device Embolization (Safety)
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.
Time frame
6 months4
Pulmonary or Aortic Vessel Stenosis (Safety)
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.
Time frame
6 monthsSecondary outcomes
1
Significant obstruction of the left pulmonary artery
Significant obstruction of the left pulmonary artery is defined as less than 30% flow to the left lung by lung perfusion scan or a peak instantaneous gradient in left pulmonary artery ≥35 mmHg by echocardiogram if lung perfusion scan is not available or as determined by the interventional cardiologist based on angiographic appearance.
Time frame
6 months2
Significant obstruction of the aorta
Significant obstruction of the aorta is defined as a gradient of ≥20 mmHg in the aortic isthmus by invasive aortic catheterization or a mean gradient ≥20 mmHg in the aortic isthmus by echocardiogram if invasive aortic catheterization is not available.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Le Bonheur Children's Hospital
Lead sponsor
Abbott
Collaborator
Source ClinicalTrials.gov
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