Cure My Disease

Don't miss your cure!

 Log in / Sign up

New heart valve study could offer seniors a Surgery-Free option

NCT ID NCT06861361

Disease control Sponsor: Ceric Sàrl 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a newer, less-invasive valve replacement (Myval THV) works as well as traditional open-heart surgery in people aged 65 to 75 with severe aortic stenosis. About 1,180 participants will be randomly assigned to one of the two procedures. The goal is to see if the newer valve is safe and effective at one month and one year after treatment.

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 1,180 people

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

Started

May 2025

Expected to finish

Sep 2037

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

65 to 75 years

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: Participant will be included if all the following criteria are met: 1. Patients aged ≥65 and ≤75 2. Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity\>4m/sec). 3. Patients with symptomatic heart disease due to severe native calcific aortic stenosis, as judged by a multidisciplinary heart team (including a cardiac surgeon), for whom SAVR or transfemoral TAVR is deemed feasible and approved by the local heart team.Signed informed consent for participation in the clinical investigation Exclusion Criteria: Participant will not be included if any one of the following conditions exists: 1. Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol 2. Life expectancy less than 1 year 3. Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components. 4. Under judicial protection, tutorship, or curatorship 5. Participation in another trial before the primary endpoint

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Symptomatic severe aortic stenosis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

Symptomatic severe aortic stenosis

How to take part

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

  1. The places running it

    49 sites in 14 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

  • Azienda Ospedaliero-Universitaria di Parma

    NOT_YET_RECRUITING

    Parma, 43126, Italy

  • Barts Heart Centre

    RECRUITING

    London, United Kingdom

  • Bucharest Clinical Emergency Hospital

    NOT_YET_RECRUITING

    Bucharest, Romania

  • CHU Lille

    RECRUITING

    Lille, France

  • CHU de Rouen

    NOT_YET_RECRUITING

    Rouen, France

  • CHUV

    RECRUITING

    Lausanne, Switzerland

  • Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust

    RECRUITING

    Cottingham, United Kingdom

  • Central military emergency university hospital

    NOT_YET_RECRUITING

    Bucharest, Romania

  • Centro Cardiologico Monzino IRCCS

    NOT_YET_RECRUITING

    Milan, Italy

  • Clinique Pasteur

    RECRUITING

    Toulouse, France

  • Department of Cardiology and Cardiac Surgery, University of Debrecen

    NOT_YET_RECRUITING

    Debrecen, Hungary

  • Fondazione Policlinico Campus Bio-Medico di Roma

    NOT_YET_RECRUITING

    Roma, 00128, Italy

  • Freeman Hospital

    NOT_YET_RECRUITING

    Newcastle upon Tyne, United Kingdom

  • German Heart Munich

    NOT_YET_RECRUITING

    München, 80636, Germany

  • Gottsegen National Cardiovascular Center

    NOT_YET_RECRUITING

    Budapest, Hungary

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital clínico universitario de Valladolid

    RECRUITING

    Valladolid, Spain

  • Hospital de Santa Cruz, ULSLO

    RECRUITING

    Carnaxide, Portugal

  • IBCV Iasi

    NOT_YET_RECRUITING

    Iași, Romania

  • IRCCS Ospedale Galeazzi Sant'Ambrogio

    NOT_YET_RECRUITING

    Milan, 20157, Italy

  • IRCCS Policlinico San Donato

    NOT_YET_RECRUITING

    San Donato Milanese, 20097, Italy

  • Imperial College Healthcare NHS Trust

    RECRUITING

    London, United Kingdom

  • Infirmerie Protestante de Lyon

    RECRUITING

    Lyon, France

  • Institute of Cardiovascular Diseases of Vojvodina

    RECRUITING

    Kamenitz, Serbia

  • Krankenhaus der Barmherzigen Brüder Trier

    NOT_YET_RECRUITING

    Trier, 54292, Germany

  • Massy-Hôpital Jacques Cartier

    RECRUITING

    Massy, France

  • Medical Univeristy of Warsaw

    NOT_YET_RECRUITING

    Warsaw, 02097, Poland

  • Medical University of Graz

    RECRUITING

    Graz, 8036, Austria

  • Medical University of Vienna

    RECRUITING

    Vienna, 1090, Austria

  • Military Hospital in Wroclaw

    NOT_YET_RECRUITING

    Wroclaw, 50981, Poland

  • Military Institute of Medicine in Warsaw

    NOT_YET_RECRUITING

    Warsaw, Poland

  • Montevergine Clinic

    NOT_YET_RECRUITING

    Mercogliano, 83013, Italy

  • Morriston Hospital

    RECRUITING

    Swansea, United Kingdom

  • National Institute of Cardiology

    NOT_YET_RECRUITING

    Warsaw, 04628, Poland

  • North-Estonia Medical Centre Foundation

    RECRUITING

    Tallinn, 13419, Estonia

  • Pomorski Uniwersytet Medyczny w Szczecinie

    NOT_YET_RECRUITING

    Szczecin, 70111, Poland

  • Poznan University Hospital

    NOT_YET_RECRUITING

    Poznan, 61848, Poland

  • Provincial Specialist Hospital in Wroclaw

    NOT_YET_RECRUITING

    Wroclaw, Poland

  • Royal Papworth Hospital

    NOT_YET_RECRUITING

    Cambridge, United Kingdom

  • Royal Victoria Hospital

    NOT_YET_RECRUITING

    Belfast, United Kingdom

  • Sheffield Teaching Hopitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Sheffield, United Kingdom

  • UKC Ljubljana

    RECRUITING

    Ljubljana, 1000, Slovenia

  • University Clinical Center of Serbia

    NOT_YET_RECRUITING

    Belgrade, Serbia

  • University Hospital Frankfurt

    NOT_YET_RECRUITING

    Frankfurt, 60596, Germany

  • University Hospital Sussex NHS foundation Trust

    RECRUITING

    Brighton, United Kingdom

  • University Hospitals Coventry and Warwickshire NHS Trust

    RECRUITING

    Coventry, United Kingdom

  • University Hostpital Sankt Pölten

    RECRUITING

    Sankt Pölten, 3100, Austria

  • University of Szeged

    NOT_YET_RECRUITING

    Szeged, Hungary

  • Universitätsklinikum Hamburg-Eppendorf

    NOT_YET_RECRUITING

    Hamburg, 20246, Germany

More trials for these conditions

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