NCT06587282
Active, Not Recruiting
N/A
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)
ConditionsPatent Ductus Arteriosus (PDA)
InterventionsBloom Micro Occluder System
Overview
- Phase
- N/A
- Intervention
- Bloom Micro Occluder System
- Conditions
- Patent Ductus Arteriosus (PDA)
- Sponsor
- Merit Medical Systems, Inc.
- Enrollment
- 55
- Locations
- 22
- Primary Endpoint
- Safety Endpoint
- Status
- Active, Not Recruiting
- Last Updated
- 19 days ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
PDA treatment
PDA treated with Bloom Micro Occluder System
Intervention: Bloom Micro Occluder System
Outcomes
Primary Outcomes
Safety Endpoint
Time Frame: 30 days
Composite rate of device-related Major Adverse Events (MAE) of interest through 30 days following the index procedure.
Effectiveness Endpoint
Time Frame: 6 Months
The rate of Clinical Success achieved at the 6-month follow-up visit.
Study Sites (22)
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