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

NCT ID NCT06898086

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

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

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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

Contacts and locations

Locations

AOUP- Azienda Ospedaliera Universitaria Pisana
NOT_YET_RECRUITING

Pisa, Basel-Stadt, 56126, Italy
Azienda Ospedaliera Universitaria Senese
NOT_YET_RECRUITING

Siena, 53100, Italy
Azienda Ospedaliero Policlinico Universitaria G. Rodolico- San Marco Catania
NOT_YET_RECRUITING

Catania, 95123, Italy
Azienda Sanitaria Universitaria Integrata di Trieste
NOT_YET_RECRUITING

Trieste, 34128, Italy
Clinical Trial Center Maastricht B.V
NOT_YET_RECRUITING

Maastricht, 6229, Netherlands
Clinique Pasteur
NOT_YET_RECRUITING

Toulouse, 31076, France
Elisabeth Krankenhaus Essen
NOT_YET_RECRUITING

Essen, 45138, Germany
Fondazione Policlinico Universitario Campus Biomedico
RECRUITING

Roma, 00128, Italy
IRCCS ISMETT Palermo
NOT_YET_RECRUITING

Palermo, Basel-Stadt, 90127, Italy
Institut Arnault Tzanck
NOT_YET_RECRUITING

Nice, 06700, France
Klinikum Klagenfurt am Wörthersee
NOT_YET_RECRUITING

Klagenfurt, 9020, Austria
Královské Vinohrady University Hospital
NOT_YET_RECRUITING

Prague, 10034, Czechia
Medical University Graz
RECRUITING

Graz, 8036, Austria
Nemocnice Na Homolce
NOT_YET_RECRUITING

Prague, 15030, Czechia
OLVG Hospital Amsterdam
NOT_YET_RECRUITING

Amsterdam, 1091, Netherlands
Ospedale dell'Angelo - ULSS 3 Serenissima
NOT_YET_RECRUITING

Mestre, 30174, Italy
Stichting Amsterdam UMC
NOT_YET_RECRUITING

Amsterdam, 1081, Netherlands
University Hospital Basel
RECRUITING

Basel, Canton of Basel-City, 4031, Switzerland
University Hospital Zurich
NOT_YET_RECRUITING

Zurich, 8091, Switzerland
Universitätsklinikum Düsseldorf
NOT_YET_RECRUITING

Düsseldorf, North Rhine-Westphalia, 40221, Germany
Universitätsklinikum Freiburg- Universitäts-Herzzentrum Campus Bad Krozingen
NOT_YET_RECRUITING

Freiburg im Breisgau, 79189, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
NOT_YET_RECRUITING

Lübeck, 23562, Germany
Universitätsklinikum Ulm
NOT_YET_RECRUITING

Ulm, 89081, Germany

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