New heart valve shows promise for High-Risk patients
NCT ID NCT03417011
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.
Disclaimer
Read more
Show less
This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for AORTIC VALVE STENOSIS are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
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