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Heart valve trial asks: do we really need that extra artery test?

NCT ID NCT06898086

Disease control Sponsor: Rede Optimus Hospitalar SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This study looks at people with severe aortic stenosis who need a new heart valve (TAVI). Normally, doctors do a coronary angiogram first to check for blocked arteries. But this test can cause kidney damage or bleeding, especially in older patients. The trial will compare the usual approach to a simpler one without the angiogram, to see if it is just as safe and effective. About 620 participants across Europe will be followed for two years.

What this could mean

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

Active substance
Transcatheter aortic valve implantation (TAVI) using the Myval™ heart valve
What this could lead to
If successful, this could simplify the TAVI procedure for many patients, reducing risks like kidney injury and bleeding from unnecessary angiography.
What could go wrong
This is a non-inferiority trial, so it may only show that skipping angiography is not worse than the standard approach. The results may not apply to patients with chest pain or those who had prior coronary procedures.

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 620 people

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

Started

Aug 2025

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: * Patient is older than 18 years with severe AS considered for TAVI by a multidisciplinary heart team. * Patient is candidate for transfemoral TAVI as per local standards and current guidelines. * Patient is willing and capable to give written consent to participate to the trial and confirmed to be able to attend the expected follow up visits. Exclusion Criteria: * Patient had a coronary angiogram with or without PCI and/or coronary CT and/or CABG within last 5 years. * Left main PCI in the medical history * Patient has CCS of 3 or more. * Patient has left ventricular ejection fraction \<30%. * Patients in whom TAVI through femoral access is ad priori not possible based on clinical assessment or medical history * Patient has been treated for acute myocardial infarction within 30 days before randomization. * Patient has a planned open-heart surgery. * Patient has a life expectancy less than 1 year due to other severe non-cardiac disease. * Patient is participating in another clinical study with an investigational product that has not yet completed the follow up period. * Patient has received previous treatment for aortic valve implantation or replacement. * Female patient who is pregnant at the time of inclusion and female patient of childbearing potential

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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.

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

    23 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • AOUP- Azienda Ospedaliera Universitaria Pisana

    Pisa, Basel-Stadt, 56126, Italy

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100, Italy

  • Azienda Ospedaliero Policlinico Universitaria G. Rodolico- San Marco Catania

    Catania, 95123, Italy

  • Azienda Sanitaria Universitaria Integrata di Trieste

    Trieste, 34128, Italy

  • Clinical Trial Center Maastricht B.V

    Maastricht, 6229, Netherlands

  • Clinique Pasteur

    Toulouse, 31076, France

  • Elisabeth Krankenhaus Essen

    Essen, 45138, Germany

  • Fondazione Policlinico Universitario Campus Biomedico

    Roma, 00128, Italy

  • IRCCS ISMETT Palermo

    Palermo, Basel-Stadt, 90127, Italy

  • Institut Arnault Tzanck

    Nice, 06700, France

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020, Austria

  • Královské Vinohrady University Hospital

    Prague, 10034, Czechia

  • Medical University Graz

    Graz, 8036, Austria

  • Nemocnice Na Homolce

    Prague, 15030, Czechia

  • OLVG Hospital Amsterdam

    Amsterdam, 1091, Netherlands

  • Ospedale dell'Angelo - ULSS 3 Serenissima

    Mestre, 30174, Italy

  • Stichting Amsterdam UMC

    Amsterdam, 1081, Netherlands

  • University Hospital Basel

    Basel, Canton of Basel-City, 4031, Switzerland

  • University Hospital Zurich

    Zurich, 8091, Switzerland

  • Universitätsklinikum Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40221, Germany

  • Universitätsklinikum Freiburg- Universitäts-Herzzentrum Campus Bad Krozingen

    Freiburg im Breisgau, 79189, Germany

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, 23562, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

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