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New heart valve could save lives without Open-Heart surgery

NCT ID NCT05172960

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 7 times

Summary

This trial is testing a new heart valve called SAPIEN X4/X4S in over 1,200 people with severe aortic stenosis, a condition where the heart's aortic valve narrows. The valve is inserted through a catheter, avoiding open-heart surgery. Researchers are measuring how many patients die or have a stroke, and whether patients feel better and can do more activities.

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/X4S transcatheter heart valve
What this could lead to
If successful, this could provide a safer, less invasive treatment option for people with severe aortic stenosis, potentially reducing death and stroke risks.
What could go wrong
This is an early-stage device trial without a control group, so results may not prove superiority over existing valves. Risks include stroke, death, and valve complications.

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 1,234 people

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

Started

Jun 2022

Expected to finish

Jan 2037

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. Severe, calcific AS 2. Native aortic annulus size suitable for SAPIEN X4 THV 3. NYHA functional class ≥ II 4. 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. Aortic valve is unicuspid, bicuspid or non-calcified 3. Pre-existing mechanical or bioprosthetic valve in any position 4. Severe aortic regurgitation (\> 3+) 5. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis 6. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months 7. Left ventricular ejection fraction \< 20% 8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation 10. Increased risk of coronary artery obstruction after THV implantation 11. Myocardial infarction within 30 days prior to the study procedure 12. Hypertrophic cardiomyopathy with subvalvular obstruction 13. Subjects with planned concomitant ablation for atrial fibrillation 14. Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI) 15. Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion. 16. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD) 17. Endocarditis within 180 days prior to the study procedure 18. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure 19. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure 20. Renal insufficiency and/or renal replacement therapy 21. Leukopenia, anemia, thrombocytopenia 22. Inability to tolerate or condition precluding treatment with antithrombotic therapy 23. Hypercoagulable state or other condition that increases risk of thrombosis 24. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication 25. Subject refuses blood products 26. BMI \> 50 kg/m2 27. Estimated life expectancy \< 24 months 28. Female who is pregnant or lactating 29. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments 30. Participating in another investigational drug or device study that has not reached its primary endpoint 31. Subject considered to be part of a vulnerable population

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

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

Aortic stenosis, severe

How to take part

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

  1. The places running it

    26 sites. 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

    Elk Grove Village, Illinois, 60007, United States

  • Allegheny General Hospital

    ACTIVE_NOT_RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Via Christi St. Francis (Cardiovascular Research Institute of Kansas)

    RECRUITING

    Wichita, Kansas, 67226, United States

  • Atlantic Health System Morristown

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Bay Area Structural Heart at Sutter Health

    RECRUITING

    San Francisco, California, 94109, United States

  • Baylor Heart and Vascular Hospital

    RECRUITING

    Dallas, Texas, 75226, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Carolinas Health System

    ACTIVE_NOT_RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centennial Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • CentraCare Heart and Vascular Center

    ACTIVE_NOT_RECRUITING

    Saint Cloud, Minnesota, 56303, United States

  • Christchurch Hospital

    ACTIVE_NOT_RECRUITING

    Christchurch, 8011, New Zealand

  • Columbia University Medical Center/NYPH

    RECRUITING

    New York, New York, 10032, United States

  • Cornell Medical Center

    RECRUITING

    New York, New York, 10021, United States

  • Dartmouth-Hitchcock Medical Center, Hanover

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Emory University Atlanta

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30322, United States

  • HCA Houston Healthcare Medical Center

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77004, United States

  • Hamilton Health Services

    ACTIVE_NOT_RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Hartford Hospital

    ACTIVE_NOT_RECRUITING

    Hartford, Connecticut, 06102, United States

  • Henry Ford Hospital

    ACTIVE_NOT_RECRUITING

    Detroit, Michigan, 48202, United States

  • Hoag Memorial Hospital Presbyterian

    ACTIVE_NOT_RECRUITING

    Newport Beach, California, 92663, United States

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

    ACTIVE_NOT_RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • Kaiser Los Angeles

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90027, United States

  • Kaiser Portland

    RECRUITING

    Clackamas, Oregon, 97015, United States

  • Kaiser San Francisco Medical Center

    ACTIVE_NOT_RECRUITING

    San Francisco, California, 94115, United States

  • Mayo Clinic Rochester

    ACTIVE_NOT_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical City Dallas Hospital

    ACTIVE_NOT_RECRUITING

    Dallas, Texas, 75230, United States

  • Medstar Union Memorial Hospital

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • Methodist Le Bonheur Healthcare

    ACTIVE_NOT_RECRUITING

    Germantown, Tennessee, 38138, United States

  • Montefiore Medical Center

    ACTIVE_NOT_RECRUITING

    New York, New York, 10458, United States

  • Naples Community Hospital Healthcare System

    ACTIVE_NOT_RECRUITING

    North Naples, Florida, 34102, United States

  • NorthShore University HealthSystem Research Institute Evanston

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Northwestern University Chicago

    RECRUITING

    Evanston, Illinois, 60611, United States

  • Novant Health and Heart Vascular Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Oklahoma Cardiovascular Research Group Oklahoma City

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Oklahoma Heart Institute

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Piedmont Heart Institute

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30309, United States

  • Pinnacle Health Harrisburg

    COMPLETED

    Harrisburg, Pennsylvania, 17101, United States

  • Providence Heart & Vascular Institute Portland

    ACTIVE_NOT_RECRUITING

    Portland, Oregon, 97225, United States

  • Royal Adelaide Hospital

    ACTIVE_NOT_RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Rush University Medical Center Chicago

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60612, United States

  • Rutgers Robert Wood Johnson Medical School

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Saint Luke's Hospital

    ACTIVE_NOT_RECRUITING

    Kansas City, Missouri, 64111, United States

  • Saint Thomas Health

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • Scripps Memorial Hospital La Jolla

    ACTIVE_NOT_RECRUITING

    La Jolla, California, 92037, United States

  • Sentara Norfolk General Hospital

    ACTIVE_NOT_RECRUITING

    Norfolk, Virginia, 23507, United States

  • Silver Cross Hospital

    RECRUITING

    New Lenox, Illinois, 60541, United States

  • St. Andrews War Memorial Hospital

    ACTIVE_NOT_RECRUITING

    Spring Hill, Queensland, 4000, Australia

  • St. Patrick Hospital

    ACTIVE_NOT_RECRUITING

    Missoula, Montana, 59802, United States

  • St. Paul's Hospital System

    ACTIVE_NOT_RECRUITING

    Vancouver, British Columbia, V6E 1M7, Canada

  • St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC

    ACTIVE_NOT_RECRUITING

    Carmel, Indiana, 46290, United States

  • Stanford University

    ACTIVE_NOT_RECRUITING

    Stanford, California, 94305, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Cleveland Clinic Foundation

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44195, United States

  • The Heart Hospital Baylor Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • The Royal Melbourne Hospital

    ACTIVE_NOT_RECRUITING

    Parkville, 3050, Australia

  • The Valley Hospital

    ACTIVE_NOT_RECRUITING

    Ridgewood, New Jersey, 07450, United States

  • UC Davis Medical Center Sacramento

    ACTIVE_NOT_RECRUITING

    Sacramento, California, 95817, United States

  • UC Health Northern Colorado (Medical Center of the Rockies)

    ACTIVE_NOT_RECRUITING

    Loveland, Colorado, 80538, United States

  • University at Buffalo - Kaleida Health

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of Kansas Medical Center

    ACTIVE_NOT_RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Texas Memorial Hermann

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • University of Washington Seattle

    ACTIVE_NOT_RECRUITING

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University - Barnes-Jewish Hospital Saint Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

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