PREEMIE: Study for Treatment of PDA in Premature Infants
Running, not enrolling · Not applicable
Conditions studied: Patent Ductus Arteriosus (PDA)
In brief
This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.
Key facts
- Study ID
- NCT06587282
- Run by
- Merit Medical Systems, Inc.
- People needed
- 55
- Starts
- 2025-03-06
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-05-15
Who can join
Age: 0 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is age ≥5 days at time of enrollment.
- Subject has a diagnosis of a hemodynamically significant patent ductus arteriosus (PDA) requiring closure.
- Subject has a PDA is ≤4.0 mm in diameter.
- Subject has a PDA is ≥5 mm in length.
- Subject's weight is between 600-2500 grams at time of enrollment.
You may not qualify if…
- Subject has pre-existing coarctation of the aorta.
- Subject has pre-existing left pulmonary artery stenosis.
- Subject has an Intracardiac thrombus that may interfere with the implant procedure
- Subject has other known hemodynamically significant congenital heart disease conditions at time of enrollment requiring intervention
- Subject has an active systemic infection at the time of enrollment.
Where it is running
- UC Davis Health — Sacramento, California, United States
- UC San Diego-Rady Children's Hospital — San Diego, California, United States
- Memorial Healthcare System-Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
- Nicklaus Children's Hospital — Miami, Florida, United States
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States
- Washington University-St. Louis Children's Hospital — St Louis, Missouri, United States
- Le Bonheur Children's Hospital — Memphis, Tennessee, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
- Herma Heart Institute-Children's Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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