RECRUITING

PREEMIE: Study for Treatment of PDA in Premature Infants

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Conditions

Patent Ductus Arteriosus (PDA)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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 (PREMIE)

Quick Facts

Study Start:2025-03-06
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06587282

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.

Ages Eligible for Study:5 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is age ≥5 days at time of enrollment.
  2. * Subject has a diagnosis of a hemodynamically significant patent ductus arteriosus (PDA) requiring closure.
  3. * Subject has a PDA is ≤4.0 mm in diameter.
  4. * Subject has a PDA is ≥5 mm in length.
  5. * Subject's weight is between 600-2500 grams at time of enrollment.
  1. * Subject has pre-existing coarctation of the aorta.
  2. * Subject has pre-existing left pulmonary artery stenosis.
  3. * Subject has an Intracardiac thrombus that may interfere with the implant procedure
  4. * 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.
  5. * Subject has an active systemic infection at the time of enrollment.

Contacts and Locations

Study Contact

Susan Mann
CONTACT
12816149664
susan.mann@merit.com
Vicky Brunk
CONTACT
17178733309
vicky.brunk@merit.com

Principal Investigator

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

Study Locations (Sites)

UC Davis Health
Sacramento, California, 95817
United States
UC San Diego-Rady Children's Hospital
San Diego, California, 92123
United States
Memorial Healthcare System-Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
United States
Washington University-St. Louis Children's Hospital
Saint Louis, Missouri, 63110
United States
Nationwide Children's Hospital
Columbus, Ohio, 43215
United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Herma Heart Institute-Children's Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Merit Medical Systems, Inc.

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

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 Registration Dates

Study Start Date2025-03-06
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-03-06
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Patent Ductus Arteriosus (PDA)