Status:
RECRUITING
PREEMIE: Study for Treatment of PDA in Premature Infants
Lead Sponsor:
Merit Medical Systems, Inc.
Conditions:
Patent Ductus Arteriosus (PDA)
Eligibility:
All Genders
5+ years
Phase:
NA
Brief 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 (P...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06587282
Start Date
March 6 2025
End Date
June 1 2026
Last Update
August 11 2025
Active Locations (10)
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1
UC Davis Health
Sacramento, California, United States, 95817
2
UC San Diego-Rady Children's Hospital
San Diego, California, United States, 92123
3
Memorial Healthcare System-Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
4
Nicklaus Children's Hospital
Miami, Florida, United States, 33155