Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06587282

PREEMIE: Study for Treatment of PDA in Premature Infants

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Patent Ductus Arteriosus (PDA) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases

Age range

5 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Health, Sacramento, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bloom Micro Occluder System

Device

Percutaneous transcatheter closure of PDA using Bloom Micro Occluder System

Primary outcomes

  1. Safety Endpoint

    Time frame: 30 days

    Composite rate of device-related Major Adverse Events (MAE) of interest through 30 days following the index procedure.

  2. Effectiveness Endpoint

    Time frame: 6 Months

    The rate of Clinical Success achieved at the 6-month follow-up visit.

Sponsors and collaborators

Lead sponsor

Merit Medical Systems, Inc.

Industry

Registry information

Official study title

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)

Acronym: PREEMIE

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.