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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Percutaneous transcatheter closure of PDA using Bloom Micro Occluder System
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
Safety Endpoint
Composite rate of device-related Major Adverse Events (MAE) of interest through 30 days following the index procedure.
Time frame: 30 days
Effectiveness Endpoint
The rate of Clinical Success achieved at the 6-month follow-up visit.
Time frame: 6 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Nicklaus Children's Hospital
Miami, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Washington University-St. Louis Children's Hospital
St Louis, Missouri, 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