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New heart valve passes safety check in 57 patients

NCT ID NCT02987387

Disease control Sponsor: Edwards Lifesciences 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at the SAPIEN XT heart valve, which is placed through a thin tube (catheter) to fix a failed valve in the heart's right ventricle. Researchers wanted to confirm it is safe and works well. They enrolled 57 people with a narrowed or leaky heart valve conduit. The main goal was to see if the valve prevented death or the need for another procedure.

What this could mean

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

Active substance
SAPIEN XT Transcatheter Heart Valve (a replacement heart valve delivered through a catheter)
What this could lead to
If successful, this confirms a less invasive option for replacing a failed heart valve conduit, reducing the need for open-heart surgery.
What could go wrong
This is a post-approval study with a small number of participants (57), so results may not apply to all patients. Risks include bleeding, infection, or the valve not working as intended.

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

57 people

The number who actually took part.

Started

Jul 2017

Finished

Sep 2025

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

Pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention.

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: 1. Patient has a dysfunctional, non-compliant RVOT conduit. 2. The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Inability to tolerate an anticoagulation/antiplatelet regimen 2. Active bacterial endocarditis

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Conditions

The condition(s) this trial relates to.

Aortic Valve Disease cardiovascular disorder Congenital Abnormalities congenital heart disease heart disorder Pulmonary Atresia 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.

Cardiovascular diseases Congenital abnormalities Heart defects, congenital Heart diseases Pulmonary valve insufficiency Pulmonary valve stenosis

Contacts and locations

Locations

  • Advocate Children's Hospital

    Oak Lawn, Illinois, 60453, United States

  • Children's Heart Center Nevada

    Las Vegas, Nevada, 89109, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Mount Sinai Beth Israel

    New York, New York, 10003, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112, United States

  • The University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Alabama

    Birmingham, Alabama, 35294, United States

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