The U.S. PDA Registry

Starting soon

Conditions studied: Ductus Arteriosus, Patent

In brief

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.

Key facts

Study ID

NCT04205877

Run by

Le Bonheur Children's Hospital

People needed

5000

Starts

2020-01-01

Expected to finish

2031-12-01

Last updated by the study team

2019-12-20

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of PDA.
• Clinical indication for transcatheter PDA closure (discretion of the physician).
• Weight <2 kg at the time of device implant.

You may not qualify if…

• 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.

Where it is running

• LeBonheur Children's Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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