PREEMIE: Study for Treatment of PDA in Premature Infants
- Conditions
- Patent Ductus Arteriosus (PDA)
- Interventions
- Device: Bloom Micro Occluder System
- Registration Number
- NCT06587282
- Lead Sponsor
- Merit Medical Systems, Inc.
- 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 (PDA) in pre-mature infants over a period of 6 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 55
- 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.
- 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, e.g., valvular atresia, Tetralogy of Fallot, atrial septal defect, ventricular septal defect, transposition of the great vessels, etc.
- Subject has an active systemic infection at the time of enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PDA treatment Bloom Micro Occluder System PDA treated with Bloom Micro Occluder System
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
UC Davis Health
🇺🇸Sacramento, California, United States
UC San Diego-Rady Children's Hospital
🇺🇸San Diego, California, United States
Memorial Healthcare System-Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Washington University-St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Herma Heart Institute-Children's Wisconsin
🇺🇸Milwaukee, Wisconsin, United States