Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Tiny heart, tiny device: new hope for premature babies

NCT ID NCT06587282

Disease control Sponsor: Merit Medical Systems, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a small device called the BLOOM Micro-Occluder to close a common heart hole (PDA) in premature babies. About 55 babies weighing between 600 and 2500 grams will be enrolled. The goal is to see if the device is safe and works well over 6 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 55 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 days and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Patent ductus arteriosus (PDA) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

patent ductus arteriosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Patent ductus arteriosus (PDA)

Contacts and locations

Locations

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30342, United States

  • Herma Heart Institute-Children's Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38103, United States

  • Memorial Healthcare System-Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021, United States

  • Nicklaus Children's Hospital

    Miami, Florida, 33155, United States

  • UC Davis Health

    Sacramento, California, 95817, United States

  • UC San Diego-Rady Children's Hospital

    San Diego, California, 92123, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Washington University-St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.