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New heart valve shows promise in large trial

NCT ID NCT02088554

Disease control Sponsor: Medtronic Cardiac Surgery 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new surgical heart valve (Model 400) in over 1,300 people with aortic valve disease. The valve is designed to replace the damaged aortic valve and improve blood flow. Researchers are checking how safe the valve is and how well it works over one year, looking at heart function and complication rates.

What this could mean

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

Active substance
Model 400 aortic valve bioprosthesis (a replacement heart valve made from cow tissue)
What this could lead to
If successful, this valve could offer a safe and effective option for people needing aortic valve replacement, improving heart function and quality of life.
What could go wrong
This is a single-arm study without a comparison group, so results may not prove superiority over existing valves. Risks include typical valve-related complications like blood clots, infection, or valve failure over time.

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

1,312 people

The number who actually took part.

Started

May 2014

Expected to finish

Dec 2035

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

18 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. Patient has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following: i. Left atrial appendage (LAA) ligation ii. CABG (coronary artery bypass grafting) iii. Patent foramen ovale (PFO) closure iv. Ascending aortic aneurysm or dissection repair not requiring circulatory arrest v. Resection of a sub-aortic membrane not requiring myectomy 2. Patient is geographically stable and willing to return to the implanting site for all follow-up visits 3. Patient is of legal age to provide informed consent in the country where they enroll in the trial 4. Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial Exclusion Criteria: 1. Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve 2. Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis 3. Patient presents with active endocarditis, active myocarditis or other systemic infection 4. Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including: * Ascending aortic aneurysm or dissection repair requiring circulatory arrest * Acute Type A aortic dissection * Ventricular aneurysm * Porcelain aorta * Hostile mediastinum * Hypertrophic obstructive cardiomyopathy (HOCM) * Documented pulmonary hypertension (systolic \>60mmHg) 5. Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to: * Child-Pugh Class C liver disease * Terminal cancer * End-stage lung disease 6. Patient has renal failure, defined as dialysis therapy or glomerular filtration rate(GFR)\<30 mL/min/1.73 m2 7. Patient has hyperparathyroidism 8. Patient is participating in another investigational device or drug trial or observational competitive study 9. Patient is pregnant, lactating or planning to become pregnant during the trial period 10. Patient has a documented history of substance (drug or alcohol) abuse 11. Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography 12. Patient has systolic ejection fraction (EF)\<20% as assessed by echocardiography 13. Patient has Grade IV Diastolic Dysfunction 14. Patient has documented bleeding diatheses 15. Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment 16. Patient requires emergency surgery

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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 stenosis

Contacts and locations

Locations

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215-4330, United States

  • Cardiothoracic and Vascular Surgeons (CTVS)

    Austin, Texas, 78756-4080, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195-0001, United States

  • Deutsches Herzzentrum München

    Munich, München, DE 80636, Germany

  • Erasmus MC

    Rotterdam, 3015 CE, Netherlands

  • Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital

    London, SE1 7EH, United Kingdom

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289, Germany

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Hôpital Bichat - Claude Bernard

    Paris, 75018, France

  • Hôpital Cardiologique du Haut-Lévêque

    Bordeaux, 33604, France

  • Inselspital - Universitätsspital Bern

    Bern, 3010, Switzerland

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

    Québec, G1V 4G5, Canada

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA, Netherlands

  • London Health Sciences Centre - University Campus

    London, Ontario, N6A 5A5, Canada

  • Maimonides Medical Center

    Brooklyn, New York, 11219, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407-1139, United States

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8, Canada

  • New York-Presbyterian Hospital/Columbia University Medical Center

    New York, New York, 10032, United States

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73135, United States

  • Ospedale San Raffaele - Milano

    Milan, 20132, Italy

  • Piedmont Hospital

    Atlanta, Georgia, 30309, United States

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606, United States

  • Riverside Methodist Hospital (OhioHealth)

    Columbus, Ohio, 43214, United States

  • The Mount Sinai Medical Center

    New York, New York, 10029, United States

  • Toronto General Hospital

    Toronto, M5G 2C4, Canada

  • Uniklinik Köln

    Cologne, Köln, 50924, Germany

  • University of Colorado Hospital

    Aurora, Colorado, 80045-2545, United States

  • University of Florida Shands

    Gainesville, Florida, 32610, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Michigan Cardiovascular Center

    Ann Arbor, Michigan, 48109-5853, United States

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • University of Southern California (USC) University Hospital

    Los Angeles, California, 90033-5313, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195-0001, United States

  • Universitäts Klinikum Frankfurt - Goethe-Universität

    Frankfurt, 60590, Germany

  • UniversitätsSpital Zürich

    Zurich, 8091, Switzerland

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