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

Heart device for preemies under scrutiny in new safety study

NCT ID NCT04371081

Disease control Sponsor: Abbott Medical Devices 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study monitors 70 infants who receive the Amplatzer Piccolo Occluder to close a hole in the heart called patent ductus arteriosus (PDA). The device is placed through a blood vessel, avoiding open-heart surgery. Researchers track complications and how well the hole closes over 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Amplatzer Piccolo Occluder (a small device placed in the heart to close a hole)
What this could lead to
If successful, this study confirms that the device is safe and works well for closing a common heart defect in premature and low-weight babies.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove cause and effect. Risks include device-related complications like blood clots or improper closure.

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.

Participants

About 70 people

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

Started

Apr 2020

Expected to finish

Jul 2027

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.

Who is studied

All patients with patent ductus arteriosus (PDA) in whom an Amplatzer™ Piccolo Occluder (Piccolo) implant was attempted will be included in this registry.

Ages

3 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: The device is used to percutaneously close the PDA of a patient who meets all of the following: * PDA ≤4 mm in diameter * PDA ≥3 mm in length * Weight ≥700 g Exclusion Criteria: * Age \<3 days * Coarctation of the aorta * Left pulmonary artery stenosis * Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension * Thrombus in the implant site, or sign of venous thrombus in a vessel in which the occluder is inserted and delivered * Endocarditis, or infection that can cause bacteremia * Allergic or potentially allergic to nickel

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Patent ductus arteriosus 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

Contacts and locations

Locations

  • Showa University Hospital

    Tokyo, Japan

More trials for these conditions

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