PREEMIE: Study for Treatment of PDA in Premature Infants

Merit Medical Systems

Status

Enrolling

Conditions

Patent Ductus Arteriosus (PDA)

Treatments

Device: Bloom Micro Occluder System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06587282

PDA-P3-23-01

Details and patient eligibility

About

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.

Enrollment

55 estimated patients

Sex

All

Ages

5+ days old

Volunteers

No Healthy Volunteers

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, e.g., valvular atresia, Tetralogy of Fallot, atrial septal defect, ventricular septal defect, transposition of the great vessels, etc.
Subject has an active systemic infection at the time of enrollment.