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)
Status: Active_not_recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5 days
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
UC Davis Health
Sacramento
UC San Diego-Rady Children's Hospital
San Diego
Florida
Memorial Healthcare System-Joe DiMaggio Children's Hospital
Hollywood
Nicklaus Children's Hospital
Miami
Georgia
Children's Healthcare of Atlanta
Atlanta
Missouri
Washington University-St. Louis Children's Hospital
St Louis
Ohio
Nationwide Children's Hospital
Columbus
Tennessee
Le Bonheur Children's Hospital
Memphis
Texas
UT Southwestern Medical Center
Dallas
Wisconsin
Herma Heart Institute-Children's Wisconsin
Milwaukee
Time Frame
Start Date: 2025-03-06
Completion Date: 2029-03
Participants
Target number of participants: 55
Treatments
Experimental: PDA treatment
PDA treated with Bloom Micro Occluder System
Related Therapeutic Areas
Sponsors
Leads: Merit Medical Systems, Inc.