PREEMIE: Study for Treatment of PDA in Premature Infants
- Conditions
- Patent Ductus Arteriosus (PDA)
- 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
- Subject has an active systemic infection at the time of enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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 (10)
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
Nicklaus Children's Hospital
🇺🇸Miami, 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
UC Davis Health🇺🇸Sacramento, California, United StatesFrank Ing, MDPrincipal Investigator