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New heart valve device offers hope for High-Risk patients

NCT ID NCT03517436

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 CENTERA THV, which is a replacement heart valve that can be placed without open-heart surgery. It is for people with severe aortic stenosis (a narrowed heart valve) who are at intermediate risk for surgery. The study will monitor safety and how well the valve works in about 100 participants.

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

101 people

The number who actually took part.

Started

Sep 2018

Expected to finish

Jul 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

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. NYHA functional class ≥ II 3. Judged by the Heart Team to be at intermediate risk for open surgical therapy 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. Native aortic annulus size unsuitable for sizes 23, 26 or 29 mm CENTERA THV based on 3D imaging analysis 2. Aortic valve is unicuspid, bicuspid or non-calcified 3. Pre-existing mechanical or bioprosthetic valve in any position 4. Known hypersensitivity to Nitinol (nickel or titanium) 5. Severe aortic regurgitation (\> 3+) 6. Severe mitral regurgitation (\> 3+) or ≥ moderate stenosis 7. Ventricular dysfunction with left ventricular ejection fraction \< 30% 8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 9. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure 10. Subjects with planned concomitant ablation for atrial fibrillation 11. Hypertrophic cardiomyopathy with obstruction 12. Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR 13. Complex coronary artery disease 14. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath. 15. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system 16. Active bacterial endocarditis within 180 days of the valve implant procedure 17. Stroke or transient ischemic attack within 90 days of the valve implant procedure 18. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure 19. Severe lung disease or currently on home oxygen 20. Severe pulmonary hypertension 21. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure 22. History of cirrhosis or any active liver disease 23. Renal insufficiency and/or renal replacement therapy at the time of screening 24. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states 25. Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure 26. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication 27. Significant frailty as determined by the Heart Team 28. Immobility that would prevent completion of study procedures 29. Subject refuses blood products 30. Body mass index \> 50 kg/m2 31. Estimated life expectancy \< 24 months 32. Positive urine or serum pregnancy test in female subjects of childbearing potential 33. Currently participating in an investigational drug or another device study

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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 valve stenosis

Contacts and locations

Locations

  • Allegheny - Singer Research Institute

    Pittsburgh, Pennsylvania, 15212, United States

  • Atlantic Health System Hospital Corp

    Morristown, New Jersey, 07960, United States

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226, United States

  • Baylor Scott and White, Central Texas

    Temple, Texas, 76508, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Columbia University Medical Center/ NYPH

    New York, New York, 10032, United States

  • Emory University

    Atlanta, Georgia, 30308, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Saint Thomas Health

    Nashville, Tennessee, 37205, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

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

    Indianapolis, Indiana, 46290, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • The Ohio Health Research Institute

    Columbus, Ohio, 43214, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

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

    Loveland, Colorado, 80538, United States

  • University of Kansas Health System

    Kansas City, Kansas, 66160, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Memorial Hermann

    Houston, Texas, 77030, United States

  • Washington Hospital Center

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

  • Washington University/ Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

More trials for these conditions

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