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New heart valve could offer lifeline for patients with failing artificial valves

NCT ID NCT05172973

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Updated 3 times

Summary

This study is testing a new heart valve called the SAPIEN X4 in 200 people whose existing artificial aortic valve is failing. The valve is placed using a thin tube through an artery, avoiding open-heart surgery. The goal is to see if it is safe and effective at improving survival and quality of life.

What this could mean

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

Active substance
SAPIEN X4 transcatheter heart valve
What this could lead to
If successful, this could offer a safer, less invasive option for replacing failing bioprosthetic aortic valves, potentially improving survival and quality of life.
What could go wrong
This is an early study with only 200 participants. The valve may not work as well as hoped, and risks include death, stroke, or the need for additional procedures.

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 200 people

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

Started

Nov 2023

Expected to finish

Dec 2039

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

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. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency 2. Bioprosthetic valve size suitable for SAPIEN X4 THV 3. NYHA functional class ≥ II 4. Heart Team agrees the subject is at high or greater surgical risk 5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system 2. Failing valve has moderate or severe paravalvular regurgitation 3. Failing valve is unstable, rocking, or not structurally intact 4. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve 5. Increased risk of THV embolization 6. Surgical or transcatheter valve in the mitral position 7. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis 8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months 9. Left ventricular ejection fraction \< 20% 10. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 11. Increased risk of coronary artery obstruction after THV implantation 12. Myocardial infarction within 30 days prior to the study procedure 13. Hypertrophic cardiomyopathy with subvalvular obstruction 14. Subjects with planned concomitant ablation for atrial fibrillation 15. Clinically significant coronary artery disease requiring revascularization 16. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion. 17. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure 18. Endocarditis within 180 days prior to the study procedure 19. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure 20. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure 21. Renal insufficiency and/or renal replacement therapy 22. Leukopenia, anemia, thrombocytopenia 23. Inability to tolerate or condition precluding treatment with antithrombotic therapy 24. Hypercoagulable state or other condition that increases risk of thrombosis 25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication 26. Subject refuses blood products 27. Body mass index \> 50 kg/m2 28. Estimated life expectancy \< 24 months 29. Female who is pregnant or lactating 30. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments 31. Participating in another investigational drug or device study that has not reached its primary endpoint 32. Subject considered to be part of a vulnerable population

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency aortic valve stenosis

As listed by the trial registrant

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

Aortic valve insufficiency Aortic valve stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    35 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alexian Brothers Hospital Network

    RECRUITING

    Lisle, Illinois, 60532, United States

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Atlantic Health System Morristown

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Bay Area Structural Heart at Sutter Health

    RECRUITING

    San Francisco, California, 94105, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cardiovascular Research Institute of Kansas

    RECRUITING

    Wichita, Kansas, 67226, United States

  • Carolinas Health System

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Columbia University Medical Center / NYPH

    RECRUITING

    New York, New York, 10032, United States

  • Cornelll University New York

    RECRUITING

    New York, New York, 10021, United States

  • Emory University Atlanta

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Hamilton Health Sciences

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Henry Ford Hospital Detroit

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval

    RECRUITING

    Québec, Quebec, G1V4G5, Canada

  • Kaiser San Francisco

    RECRUITING

    San Francisco, California, 94115, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Union Memorial Hospital

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • Montefiore Medical Center

    RECRUITING

    New York, New York, 10458, United States

  • Naples Community Hospital Healthcare System

    RECRUITING

    Naples, Florida, 34102, United States

  • Northwestern University Chicago

    RECRUITING

    Evanston, Illinois, 60208, United States

  • Novant Health and Vascular Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Oklahoma Heart Institute

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Robert Wood Johnson University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Rochester General Hospital

    RECRUITING

    Rochester, New York, 14621, United States

  • Saint Thomas Health

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • St. Paul's Hospital Vancouver

    RECRUITING

    Vancouver, British Columbia, V6Z1Y6, Canada

  • Stanford University Medical Center

    RECRUITING

    Stanford, California, 94305, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • The Heart Hospital Baylor Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • The Valley Hospital

    RECRUITING

    Ridgewood, New Jersey, 07450, United States

  • UC Health Medical Center of the Rockies

    RECRUITING

    Loveland, Colorado, 80538, United States

  • University of Buffalo

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of Texas Memorial Hermann

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Washington Seattle

    WITHDRAWN

    Seattle, Washington, 98195, United States

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