Treatment of patent ductus arteriosus in premature infants

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 study is testing a new device to see if it can safely close a heart condition called patent ductus arteriosus in premature infants who need treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 5 Days and up
• Sex: All
• Sponsor: Merit Medical Systems, Inc. (Industry-sponsored)
• Locations: 9 sites (Sacramento, California and 8 other locations)
• Trial ID: NCT06587282 on ClinicalTrials.gov

What this trial studies

This multicenter, single-arm, prospective study evaluates the safety and effectiveness of the Bloom Micro Occluder System for treating patent ductus arteriosus (PDA) in premature infants. The study focuses on infants aged 5 days and older with a hemodynamically significant PDA that requires closure. Participants will be monitored over a period of 6 months to assess the outcomes of the intervention.

Who should consider this trial

Good fit: Ideal candidates are premature infants aged 5 days or older, weighing between 600-2500 grams, with a PDA that is hemodynamically significant and meets specific size criteria.

Not a fit: Patients with pre-existing congenital heart conditions or active systemic infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the health outcomes of premature infants with PDA.

How similar studies have performed: Other studies have explored similar interventions for PDA, but the specific use of the Bloom Micro Occluder System is novel.

Eligibility criteria

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, 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.

Where this trial is running

Sacramento, California and 8 other locations

• UC Davis Health — Sacramento, California, United States (Not_yet_recruiting)
• UC San Diego-Rady Children's Hospital — San Diego, California, United States (Not_yet_recruiting)
• Memorial Healthcare System-Joe DiMaggio Children's Hospital — Hollywood, Florida, United States (Recruiting)
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
• Washington University-St. Louis Children's Hospital — Saint Louis, Missouri, United States (Not_yet_recruiting)
• Nationwide Children's Hospital — Columbus, Ohio, United States (Not_yet_recruiting)
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States (Recruiting)
• UT Southwestern Medical Center — Dallas, Texas, United States (Not_yet_recruiting)
• Herma Heart Institute-Children's Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Howaida El-Said, MD — Rady Children's Hospital
• Study coordinator: Susan Mann

Conditions Patent Ductus Arteriosus