PREEMIE: Study for Treatment of PDA in Premature Infants
Multicenter, Single Arm Prospective, Non-Randomized Study 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 (PREEMIE)
Merit Medical Systems, Inc.
55 participants
Mar 6, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria5
- 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.
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Interventions
Percutaneous transcatheter closure of PDA using Bloom Micro Occluder System
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT06587282