Can a new heart valve match the safety of proven ones?

NCT ID NCT04275726

NEW Recruiting now Disease control Sponsor: Meril Life Sciences Pvt. Ltd. Source: ClinicalTrials.gov ↗

First seen Aug 17, 2026 · Last updated Aug 17, 2026

Summary

This trial tests whether a new transcatheter heart valve (Myval) works as safely and effectively as two existing valves (Sapien and Evolut) in people with severe aortic stenosis, a condition where the heart's main valve narrows. About 768 patients who are eligible for valve replacement will be randomly assigned to receive either the new valve or one of the existing ones. The study tracks major outcomes like death, stroke, bleeding, kidney injury, and valve function to see if the new valve is a viable alternative.

What this could mean

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

Active substance: Myval transcatheter heart valve (THV) series
What this could lead to: If successful, this could offer patients with severe aortic stenosis another safe and effective valve option for minimally invasive replacement.
What could go wrong: The trial is non-inferiority, meaning it aims to show the new valve is not worse than existing ones, not necessarily better. Risks include complications like bleeding, stroke, or need for a pacemaker.

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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

Amphia Ziekenhui Hospital
RECRUITING

Breda, 4817, Netherlands
Arnault Tzanck Institute
RECRUITING

Nice, 06200, France
Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5
NOT_YET_RECRUITING

Hamburg, 20099, Germany
Auckland City Hospital 2 Park Road
RECRUITING

Grafton, Auckland, 1023, New Zealand
Centre Hospitalier Universitaire De Rennes
NOT_YET_RECRUITING

Rennes, 35033, France
Centro Hospital Lisboa Central E.P.E. - Santa Marta
RECRUITING

Lisbon, 1169-024, Portugal
Centro Hospitalar Lisboa Ocidental EPE- Hospital Santa Cruz, Av. Prof. Dr. Reinaldo dos Santos
RECRUITING

Carnaxide, 2790-134, Portugal
Centro Hospitalar de Sao Joao
NOT_YET_RECRUITING

Porto, 4200-319, Portugal
Clinical Institute Saint Ambrogio
RECRUITING

Milan, 20149, Italy
Hippkration Hospital
RECRUITING

Athens, 11527, Greece
Hospital Cliinico Univertistario de Valladolid
RECRUITING

Valladolid, 47003, Spain
Hospital Clínico San Carlos
NOT_YET_RECRUITING

Madrid, 28040, Spain
Hospital Dante Pazanesse
RECRUITING

São Paulo, 04012-909, Brazil
Hospital Universitari Son Espases Carretera de Valldemossa
RECRUITING

Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Universitario Renei Sofia
RECRUITING

Córdoba, 5000, Spain
Hospital Universitario de Gran Canaria Dr Negrin
RECRUITING

Las Palmas, Canary Islands, 35010, Spain
Hospital de Santa Maria, Av. Prof. Egas Moniz MB
NOT_YET_RECRUITING

Lisbon, 1649-028, Portugal
Hygeia hospital
RECRUITING

Marousi, Greece
Hôpital Henri Mondor
RECRUITING

Créteil, 94000, France
Institut Cardiovascular Paris-Sud
RECRUITING

Massy, 91300, France
Institute of Cardiology
NOT_YET_RECRUITING

Warsaw, 50-013, Poland
Interbalkan European Medical Center
RECRUITING

Thessaloniki, 555 35, Greece
Isala Zwolle Hospital
ACTIVE_NOT_RECRUITING

Zwolle, Overijssel, 8025 AB, Netherlands
John Paul II Hospital
NOT_YET_RECRUITING

Krakow, Małopolskie Województwo, 31-202, Poland
Kerckhoff-KlinikForschungs GmbH
RECRUITING

Bad Nauheim, Hesse, 61231, Germany
Klinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Universitätsklinikum Regensburg
RECRUITING

Regensburg, 93053, Germany
Klinikum Braunschweig Freisestre
ACTIVE_NOT_RECRUITING

Braunschweig, 38118, Germany
Leipzig Heart Institute GmbH
RECRUITING

Leipzig, Saxony, 04289, Germany
Lille University
RECRUITING

Lille, 59000, France
Mauriliano Hospital Largo Filippo
NOT_YET_RECRUITING

Tortona, 10128, Italy
Medical University of Silesia
NOT_YET_RECRUITING

Katowice, Prussian, 40-635, Poland
North Estonia Medical Center
RECRUITING

Tallinn, Estonia
Onze lieve vrouwe gasthuis Oosterperk 9
ACTIVE_NOT_RECRUITING

Amsterdam, 1091, Netherlands
Policlinico di Catania
NOT_YET_RECRUITING

Catania, 95100, Italy
Radboud University Nijmegen
RECRUITING

Nijmegen, Gelderland, 6525 XZ, Netherlands
Republican Scientific-Practical Centre "Cardiology"
NOT_YET_RECRUITING

Minsk, 220036, Belarus
Sahlgrenska University Hospital
RECRUITING

Gothenburg, Sweden
San Donato Hospital
RECRUITING

Milan, 20121-20162, Italy
San Raffaele Hospital
RECRUITING

Milan, 20132, Italy
Semmelweis University
RECRUITING

Budapest, 1122, Hungary
Split Clinical Hospital Center
RECRUITING

Split, 21000, Croatia
St Antonius Hospital
RECRUITING

Nieuwegein, Dutch, 3435, Netherlands
Technology University Dresden Fetscherstraße 76
RECRUITING

Dresden, 01307, Germany
University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15
RECRUITING

Bad Krozingen, 79189, Germany
University Hospital Città della Salute e della Scienza Turin Bramante
NOT_YET_RECRUITING

Turin, 10126, Italy
University Hospital Dubrava Avenija Gojka Šuška 6
RECRUITING

Zagreb, 10000, Croatia
University Medical Center (UMC)
NOT_YET_RECRUITING

Groningen, 9713, Netherlands
University Medical Center Utrecht
RECRUITING

Utrecht, 3584, Netherlands
University Medical Center, Ljubljana
RECRUITING

Ljubljana, 1000, Slovenia
University hospital Banska Bystrica Námestie Ludvíka Svobodu 1
RECRUITING

Banská Bystrica, 975 17, Slovakia
University of Bologna Policlinico S. Orsola-Malpigh
NOT_YET_RECRUITING

Bologna, 40141, Italy
University of Gdansk
NOT_YET_RECRUITING

Gdansk, Pomorskie Województwo, 80-952, Poland
Uniwersytecki Szpital Kliniczny (USK) Curie-Skłodowskiej 58
RECRUITING

Wroclaw, 50-369, Poland
Uppsala University Hospital
RECRUITING

Uppsala, Sweden

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