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PREEMIE: Study for Treatment of PDA in Premature Infants

RECRUITINGN/ASponsored by Merit Medical Systems, Inc.
Actively Recruiting
PhaseN/A
SponsorMerit Medical Systems, Inc.
Started2025-03-06
Est. completion2026-08
Eligibility
Age5 Days+
Healthy vol.Accepted
Locations10 sites
View on ClinicalTrials.gov →

NCT06587282

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

Age: 5 Days+Healthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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.

Conditions2

Heart DiseasePatent Ductus Arteriosus (PDA)

Locations10 sites

UC Davis Health
Sacramento, California, 95817
Frank Ing, MD
UC San Diego-Rady Children's Hospital
San Diego, California, 92123
Howaida El-Said, MD
Memorial Healthcare System-Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Peter Guyon, MD
Nicklaus Children's Hospital
Miami, Florida, 33155
Shyam Sathanandam, MD
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Allen Ligon, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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