Not currently recruiting at University of California Health

PREEMIE: Study for Treatment of PDA in Premature Infants

a study on Heart Failure Premature Birth

Summary

Location
at UC Davis UCSD
Dates
study started
completion around

Description

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.

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)

Keywords

Patent Ductus Arteriosus (PDA), Patent Ductus Arteriosus, Bloom Micro Occluder System

Eligibility

You can join 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 CAN'T join 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, 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.

Locations

  • UC Davis Health not yet accepting patients
    Sacramento California 95817 United States
  • UC San Diego-Rady Children's Hospital not yet accepting patients
    San Diego California 92123 United States
  • Le Bonheur Children's Hospital accepting new patients
    Memphis Tennessee 38103 United States
  • Herma Heart Institute-Children's Wisconsin accepting new patients
    Milwaukee Wisconsin 53226 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Merit Medical Systems, Inc.
ID
NCT06587282
Study Type
Interventional
Participants
Expecting 55 study participants
Last Updated