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New heart valve shows promise for High-Risk patients

NCT ID NCT03417011

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new heart valve called Evolut PRO in 638 people with severe aortic stenosis who were at high risk for open-heart surgery. The valve was implanted using a thin tube through an artery, avoiding major surgery. Results showed that only 3.3% of patients died within 30 days, and most had no or only trace leakage around the new valve.

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 heart valve (a device implanted via a catheter to replace the narrowed aortic valve)
What this could lead to
If successful, this could confirm that the Evolut PRO valve is a safe and effective option for people with severe aortic stenosis who are at high risk for open-heart surgery.
What could go wrong
This was a single-arm study without a comparison group, so results may not prove superiority over other treatments. Long-term risks like valve leakage or need for re-intervention remain possible.

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

638 people

The number who actually took part.

Started

Feb 2018

Finished

Feb 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

Patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.

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: * Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement * High or greater risk for surgical aortic valve replacement as estimated by the heart team OR, 75 years or older and at intermediate risk for surgical AVR (STS risk score ≥4% or with an estimated hospital mortality ≥4% as assessed by the heart team) * Acceptable candidate for treatment with the Evolut™ PRO system in conformity with the Instructions for Use and the local regulations * Able and willing to return to the implanting site at the following follow-up visits: 1-year, 3-year and 5-year * Written informed consent obtained without assistance from a legal representative prior to enrollment in the study. Exclusion Criteria: * Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated * Preexisting mechanical heart valve in aortic position * Ongoing sepsis, including active endocarditis * Anatomically not suitable for the Evolut™ PRO system * Estimated life expectancy of less than 1 year * Participating in another trial that may influence the outcome of this study * Need for emergency surgery for any reason * Inability to understand and respond to the quality of life questionnaire

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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

  • AOU Presidio Gaspare Rodolico Policlinico

    Catania, Italy

  • Asklepios Klinik St. Georg

    Hamburg, Germany

  • Azienda Ospedaliera Ospedale Niguarda Cà Granda

    Milan, Italy

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, Italy

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

    Pisa, Italy

  • CHU Bordeaux

    Bordeaux, France

  • CHU de Liège - Hôpital du Sart Tilman

    Liège, Belgium

  • Catharina Ziekenhuis Eindhoven

    Eindhoven, Netherlands

  • Clinique Pasteur

    Toulouse, France

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago de Compostela, Spain

  • Deutsches Herzzentrum Berlin

    Berlin, Germany

  • Deutsches Herzzentrum München Klinik an der TU München

    Munich, Germany

  • Erasmus Medisch Centrum

    Rotterdam, Netherlands

  • Hadassah Medical Organisation

    Jerusalem, Israel

  • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

    Bad Oeynhausen, Germany

  • Herzzentrum Dresden GmbH Universitätsklinik

    Dresden, Germany

  • Herzzentrum Leipzig GmbH

    Leipzig, Germany

  • Hospital Universitario Central de Asturias

    Oviedo, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, Spain

  • Hôpital Henri Mondor

    Créteil, France

  • IRCCS Policlinico San Donato

    Milan, Italy

  • Inselspital - Universitätsspital

    Bern, Switzerland

  • LKH - Universitätsklinikum

    Graz, Austria

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, Netherlands

  • Oslo Universitetssykehus-Ullevål

    Oslo, Norway

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, Israel

  • Rigshospitalet

    Copenhagen, Denmark

  • Royal Victoria Hospital - Belfast Health and Social Care Trust

    Belfast, United Kingdom

  • SANA Herzchirurgie Stuttgart GmbH

    Stuttgart, Germany

  • Sana-Herzzentrum Cottbus GmbH

    Cottbus, Germany

  • St. George's Hospital

    London, United Kingdom

  • The Royal Wolverhampton Hospitals NHS - New Cross Hospital

    Wolverhampton, United Kingdom

  • Turun Yliopistollinen Keskussairaala

    Turku, Finland

  • Universitair Ziekenhuis Antwerpen

    Antwerp, Belgium

  • University Medical Centre

    Ljubljana, Slovenia

  • Universitätsklinikum Bonn

    Bonn, Germany

  • Universitätsklinikum Düsseldorf

    Düsseldorf, Germany

  • Universitätsklinikum Essen

    Essen, Germany

  • Universtitätsspital Zürich

    Zurich, Switzerland

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