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New heart valve device offers hope for patients with congenital defects

NCT ID NCT03441971

Disease control Sponsor: W.L.Gore & Associates 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new device called the GORE PV1 to replace the pulmonary valve and rebuild the right ventricular outflow tract in people with congenital heart defects. The device is designed to improve blood flow from the heart to the lungs. The study includes 15 participants aged 5 and older and will check safety and how well the device works at 6 months after the procedure.

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 15 people

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

Started

Jun 2018

Expected to finish

Mar 2030

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 years 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: 1. A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit 2. Age ≥5 years at the time of informed consent signature. Note: Additional Inclusion Criteria may apply Exclusion Criteria: 1. An artificial valve at another position or will need an artificial valve at another position (i.e. replacement at the time of index procedure or anticipated within 3 years). 2. Subjects with previously implanted pacemaker (including defibrillators). 3. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year. Note: Additional Exclusion Criteria may apply

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Conditions

The condition(s) this trial relates to.

congenital heart disease pulmonary valve insufficiency pulmonary valve stenosis tetralogy of fallot

As listed by the trial registrant

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

Heart defects, congenital Pulmonary valve insufficiency Pulmonary valve stenosis Tetralogy of fallot

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

More trials for these conditions

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