Patent Ductus Arteriosus (PDA)
Conditions
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.
Interventions
DEVICEBloom Micro Occluder System
Percutaneous transcatheter closure of PDA using Bloom Micro Occluder System
Sponsors
Merit Medical Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Days to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHowaida El-Said, MD
Rady Children's Hospital, San Diego
Outcome results
None listed