PREEMIE: Study for Treatment of PDA in Premature Infants

NCT06587282 | Active Not Recruiting FDA Device

• 1 other identifier: PDA-P3-23-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 10

Brief Summary

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)

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint

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

  30 days

• Effectiveness Endpoint

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

  6 Months

Study Arms (1)

PDA treatment

EXPERIMENTAL

PDA treated with Bloom Micro Occluder System

Device: Bloom Micro Occluder System

Interventions

Bloom Micro Occluder System DEVICE

Percutaneous transcatheter closure of PDA using Bloom Micro Occluder System

PDA treatment

Eligibility Criteria

• Age: 5 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (10)

UC Davis Health

Sacramento, California, 95817, United States

Location

UC San Diego-Rady Children's Hospital

San Diego, California, 92123, United States

Location

Memorial Healthcare System-Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Washington University-St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Herma Heart Institute-Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Howaida El-Said, MD

  Rady Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: March 6, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2025-08

Locations

US (10)