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New heart valve study aims to cut complications in aortic stenosis patients

NCT ID NCT04091048

Disease control Sponsor: Medtronic Cardiovascular 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an optimized care plan for people with a narrowed aortic heart valve who received a new valve through a catheter (TAVR). Over 1,100 patients were enrolled to see if the improved care pathway could lower risks like death, stroke, and the need for a pacemaker. The goal is to make a common heart procedure safer and more effective.

What this could mean

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

Active substance
Evolut PRO and Evolut PRO+ heart valve devices
What this could lead to
If successful, this could help standardize a safer, more effective care pathway for patients needing aortic valve replacement, reducing complications like stroke and pacemaker need.
What could go wrong
This is a post-market study, not a randomized trial, so results may not prove superiority over other approaches. Risks of TAVR include bleeding, stroke, and need for a pacemaker.

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

1,127 people

The number who actually took part.

Started

Sep 2019

Finished

Nov 2024

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

The study population includes patients with symptomatic native aortic valve stenosis that necessitates valve replacement who meet the criteria for on-label use of the Evolut™ PRO or Evolut™ PRO+ (and FX system for the addendum where applicable) system in accordance with Instructions for Use and local regulations.

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: * Acceptable candidate for treatment with the Evolut™ PRO or Evolut™ PRO+ system (FX system for the addendum where applicable) in accordance with the Instructions for Use and local regulations; * Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater; * Subject and the treating physician agree that the subject will return for all required post procedure follow-up visits; * Anatomically suitable for transfemoral TAVR with the Medtronic TAVR system; * Subject meets the legal minimum age to provide Informed Consent based on local regulatory requirements. Exclusion Criteria: * Contraindicated for treatment with the Evolut™ PRO or Evolut™ PRO+ or FX system (where applicable) in accordance with the Instructions for Use * Anatomically not suitable for the Evolut™ PRO or Evolut™ PRO+ or FX system (where applicable); * Previous aortic valve replacement * Reduced ventricular function with left ventricular ejection fraction (LVEF) \<35% as measured by resting echocardiogram; * Frailty assessments identify: * Subject is \<80 years of age and three or more of the following apply; OR subject is \> 80 years of age and two or more of the following apply * Wheelchair bound * Resides in an institutional care facility (e.g. nursing home, skilled care center) * Body Mass Index \<20kg/m2 * Grip strength \<16kg * Katz Index score ≤4 * Albumin \<3.5 g/dL * Bicuspid valve verified; * Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) \> 70°. * Implanted with pacemaker or ICD; * Prohibitive left ventricular outflow tract calcification; * Estimated life expectancy of less than 12 months due to associated non- cardiac co-morbid conditions; * Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent, adherence to the protocol required follow-up exams; * Currently participating in an investigational drug or another device trial (excluding registries); * Need for emergency surgery for any reason. * Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable\*. * Notes: Vulnerable subjects include individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. EXAMPLE Individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.

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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.

Symptomatic aortic stenosis

Contacts and locations

Locations

  • Abbott Northwestern Hospital (Minneapolis Heart)

    Minneapolis, Minnesota, 55407, United States

  • Akademiska Sjukhuset

    Uppsala, Sweden

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension St. John Hospital

    Detroit, Michigan, 48236, United States

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53125, United States

  • Austin Hospital

    Heidelberg, Australia

  • Buffalo General Medical Center

    Buffalo, New York, 14203, United States

  • California Pacific Medical Center - Sutter Health

    San Francisco, California, 94109, United States

  • Charleston Medical Center

    Charleston, West Virginia, 25304, United States

  • Dixie Regional Medical Center Intermountain

    St. George, Utah, 84770, United States

  • Emory University Hospital

    Atlanta, Georgia, 30308, United States

  • Fiona Stanley Hospital

    Murdoch, Australia

  • Fondazione Poliambulanza

    Brescia, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, Italy

  • Galway University Hospitals - University Hospital Galway (UHG)

    Galway, Ireland

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Hospital Universitario Central de Asturas

    Oviedo, Spain

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Hôpital Haut-Lévêque - CHU de Bordeaux

    Pessac, France

  • Hôpitaux Universitaires - Hôpital Henri Mondor

    Créteil, France

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • John Hunter Hospital

    Newcastle, Australia

  • Kettering Medical Center

    Kettering, Ohio, 45429, United States

  • Laval University Institute of Cardiology and Respirology of Quebec

    Québec, Quebec, G1V 4G5, Canada

  • Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18103, United States

  • Manchester Royal Infirmary

    Manchester, United Kingdom

  • Mater Private Hospital

    Dublin, Ireland

  • Medstar Union Memorial Hospital

    Baltimore, Maryland, 21218, United States

  • Monash Hospital

    Clayton, Australia

  • Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • New York Presbyterian - Columbia University Medical Center

    New York, New York, 10032, United States

  • Ohio Health Research Institute

    Columbus, Ohio, 43214, United States

  • Providence St. Patrick Hospital

    Missoula, Montana, 59802, United States

  • Royal Victoria Hospital - Belfast Health and Social Care Trust

    Belfast, United Kingdom

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Saint Vincents Hospital Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • Saint Vincents Hospital Sydney

    Sydney, Australia

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Shaare Zedek Medical Center

    Jerusalem, Israel

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • St Jan Hospital

    Bruges, Belgium

  • St. Francis Hospital

    Roslyn, New York, 11576, United States

  • St. John's Hospital/Prarie Education and Research Cooperative

    Springfield, Illinois, 62769, United States

  • St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C.

    Norwalk, Connecticut, 06851, United States

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • The Heart Hospital - Baylor Plano

    Plano, Texas, 75093, United States

  • The Mount Sinai Hospital

    New York, New York, 10029, United States

  • The Prince Charles Hospital

    Chermside West, Australia

  • The Valley Hospital

    Ridgewood, New Jersey, 07450, United States

  • UPMC Pinnacle Harrisburg

    Harrisburg, Pennsylvania, 17101, United States

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35233, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68105, United States

  • Universitätsklinikum Ulm

    Ulm, Germany

  • Vassar Brother's Medical Center

    Poughkeepsie, New York, 12601, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

  • York Hospital

    York, Pennsylvania, 17403, United States

  • ZNA Middelheim

    Antwerp, Belgium

More trials for these conditions

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