New heart valve shows promise for High-Risk patients

NCT ID NCT03417011

Completed Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

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.

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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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