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

NCT ID NCT04275726

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

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.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 988 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

Dec 2033

An estimate. End dates often move.

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.

Ages

18 years and older

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: 1. Patient ≥18 years of age. 2. Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) of the investigational site to participate in the study. 3. As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices. Exclusion Criteria: 1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study. 2. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.

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Get notified about this study

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    51 sites in 17 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.