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New hope for kids with heart valve disease: mini mechanical valve under study

NCT ID NCT03924661

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a small mechanical heart valve (15mm) in 20 children who need their aortic valve replaced due to disease or damage. The valve is designed to last and is monitored for safety and function over 5 years. Children will need lifelong blood-thinning medication to prevent clots, so this is a disease management approach, not a cure.

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 20 people

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

Started

Oct 2019

Expected to finish

Oct 2028

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

This clinical study will enroll male and female subjects from the pediatric population. Subjects must meet all eligibility criteria and written and signed informed consent must be obtained from the subject's legal guardian prior to starting the study.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Inclusion criteria for prospectively enrolled subjects * Subject's legal guardian must provide written informed consent prior to any clinical study related procedure. * Subject requires aortic valve replacement and is intended to be implanted with a 15mm SJM15 AHPJ-505 MHV as determined by the implanting physician in accordance with the Instructions for Use. * The legal guardian and site agree to follow the subject per the assessment schedule and complete all required assessments per this protocol for the duration of the clinical study. * Inclusion criteria for retrospectively enrolled subjects : In an effort to ensure data on all real-world use conditions are consistently collected and reported on, a subject is eligible to participate in this post-approval study if he/she meets all of the following inclusion criteria and meets no exclusion criterion. For those subjects with a previous implant attempt to be eligible for study participation, the following inclusion criteria must be met: * Echocardiography data at a time point greater than 90 days is available or may be acquired. * An implant was attempted with the 15mm MHV, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy. * Either: * For living subjects who already received the 15mm MHV, the legal guardian signs the study informed consent for this protocol allowing access to all relevant historical medical information, and complete all required assessments according to this protocol from the time of consent going forward (if applicable). OR * For subjects who are deceased or explanted, an implantation with 15mm MHV was attempted and the subject's legal guardian provides written informed consent for retrospective data collection of patient and study valve related information through death or explant of the study device. Exclusion Criteria: * Exclusion criteria for prospectively enrolled subjects: Subject has a contraindication to anticoagulant/antiplatelet medication. * Exclusion criteria of retrospectively enrolled subjects: None

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Conditions

The condition(s) this trial relates to.

Aortic Valve Disease aortic valve disorder

As listed by the trial registrant

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

Aortic valve disease

Contacts and locations

Locations

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Los Angeles (USC)

    Los Angeles, California, 90027, United States

  • Children's Medical Center Dallas

    Dallas, Texas, 75235, United States

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Dell Children's Medical Center

    Austin, Texas, 78723, United States

  • Deutsches Herzzentrum München des Freistaates Bayern

    München, Bavaria, 80636, Germany

  • Herzzentrum Leipzig GmbH

    Leipzig, Saxony, 04289, Germany

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Sana - Herzchirurgische Klinik Stuttgart GmbH

    Stuttgart, Baden-Wurttemberg, 70174, Germany

  • Sutter Medical Center, Sacramento

    Sacramento, California, 95816, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • Valley Children's Hospital

    Madera, California, 93636, United States

  • Variety Children's Hospital

    Miami, Florida, 33155, United States

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