PREEMIE: Study for Treatment of PDA in Premature Infants

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.

Conditions

Patent Ductus Arteriosus (PDA)

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Study Overview

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Study Details

Study overview

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.

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 (PREMIE)

PREEMIE: Study for Treatment of PDA in Premature Infants

Condition
Patent Ductus Arteriosus (PDA)
Intervention / Treatment

-

Contacts and Locations

Sacramento

UC Davis Health, Sacramento, California, United States, 95817

San Diego

UC San Diego-Rady Children's Hospital, San Diego, California, United States, 92123

Hollywood

Memorial Healthcare System-Joe DiMaggio Children's Hospital, Hollywood, Florida, United States, 33021

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30342

Saint Louis

Washington University-St. Louis Children's Hospital, Saint Louis, Missouri, United States, 63110

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43215

Memphis

Le Bonheur Children's Hospital, Memphis, Tennessee, United States, 38103

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75390

Milwaukee

Herma Heart Institute-Children's Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

5 Days to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merit Medical Systems, Inc.,

Howaida El-Said, MD, PRINCIPAL_INVESTIGATOR, Rady Children's Hospital

Study Record Dates

2026-06