Bloom Micro Occluder System: Percutaneous transcatheter closure of PDA using Bloom Micro Occluder System
Study 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
Sex
ALL
Min age
5 Days
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Safety Endpoint — 30 days Composite rate of device-related Major Adverse Events (MAE) of interest through 30 days following the index procedure.
Effectiveness Endpoint — 6 Months The rate of Clinical Success achieved at the 6-month follow-up visit.
Trial sites (9)
Facility
City
Region
Status
UC Davis Health
Sacramento
California
UC San Diego-Rady Children's Hospital
San Diego
California
Memorial Healthcare System-Joe DiMaggio Children's Hospital
Hollywood
Florida
Nicklaus Children's Hospital
Miami
Florida
Children's Healthcare of Atlanta
Atlanta
Georgia
Washington University-St. Louis Children's Hospital
St Louis
Missouri
Le Bonheur Children's Hospital
Memphis
Tennessee
UT Southwestern Medical Center
Dallas
Texas
Herma Heart Institute-Children's Wisconsin
Milwaukee
Wisconsin
More Merit Medical Systems, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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