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

May 14, 2026 updated by: Merit Medical Systems, Inc.

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Health
      • San Diego, California, United States, 92123
        • UC San Diego-Rady Children's Hospital
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Healthcare System-Joe DiMaggio Children's Hospital
      • Miami, Florida, United States, 33155
        • Nicklaus Children's Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Healthcare of Atlanta
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University-St. Louis Children's Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Le Bonheur Children's Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Herma Heart Institute-Children's Wisconsin

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PDA treatment
PDA treated with Bloom Micro Occluder System
Device: Bloom Micro Occluder System
Percutaneous transcatheter closure of PDA using Bloom Micro Occluder System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Endpoint
Time Frame: 30 days
Composite rate of device-related Major Adverse Events (MAE) of interest through 30 days following the index procedure.
30 days
Effectiveness Endpoint
Time Frame: 6 Months
The rate of Clinical Success achieved at the 6-month follow-up visit.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merit Medical Systems, Inc.

Investigators

  • Principal Investigator: Howaida El-Said, MD, Rady Children's Hospital, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

September 5, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDA-P3-23-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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