Medical Services ► Clinical Trials ► CAR25032 (PDA-P3-23-01, PREEMIE)

PREEMIE: Study for Treatment of PDA in Premature Infants (PREEMIE)

Study Details

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)

Conditions: Patent Ductus Arteriosus (PDA)

Study ID:

CAR25032 (PDA-P3-23-01, PREEMIE)

Study Description

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.

Eligibility Requirements

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.