Treatment of severe aortic stenosis (narrowing of the left heart valve through which blood flows from the heart to the rest of the body) with transfemoral TAVI (transcatheter aortic valve implantation) with or without coronary angiography (a special procedure in which dynamic X-rays of the heart are taken) during diagnostic evaluation.

Zusammenfassung der Studie

This study focuses on patients with severe aortic stenosis, a condition where the left heart valve (aortic valve) is narrowed. As a result, the heart has to work harder to pump blood, and/or blood flow to the rest of the body may be significantly restricted, leading to symptoms such as shortness of breath, chest pain, and dizziness. The recommended treatment for aortic stenosis is transcatheter aortic valve implantation (TAVI), a minimally invasive procedure in which a new valve is inserted into the old, narrowed valve. Before TAVI, a coronary angiogram is typically performed to check if the blood vessels supplying blood to the heart (coronary arteries) are blocked and to determine the correct valve size. If blockages are found, they are treated before or during the TAVI. The aim of this study is to investigate whether forgoing a coronary angiography prior to TAVI is as safe and effective as the standard method. Since this is a randomized study, the randomization process determines which of the two study groups the patient will belong to. This randomization process is comparable to flipping a coin and means that patients, after giving their consent, are randomly assigned to either the control or experimental group. The patient has a 50% chance of being assigned to one of the two groups. Both groups will use the CE-certified Myval transcatheter heart valve, which provides a precise fit and optimal performance. After TAVI, patients will be invited for follow-up examinations at 6, 12, and 24 months, where they will complete questionnaires on quality of life (EQ-5D-5L, KCCQ) and neurological performance (NIHSS, mRS). Their current medication and adverse events will also be documented.

(BASEC)

Untersuchte Intervention

to investigate whether a TAVI method without prior coronary angiography is not inferior to a conventional TAVI method, where a routine coronary angiography is performed with or without revascularization, in patients with significant aortic stenosis who do not have typical angina pectoris classified as CCS 3 or higher.

Patients will be randomly assigned to two study groups. Patients assigned to the first group, the experimental strategy group, will not undergo invasive coronary angiography during the routine diagnostic examination prior to TAVI, so the coronary status before TAVI will be unknown. In contrast, patients randomized to group two, the control strategy (standard of care), will undergo a routine diagnostic examination including invasive coronary angiography before TAVI. The percutaneous coronary intervention will be performed according to the standard of care principle.

(BASEC)

Untersuchte Krankheit(en)

Patients with severe aortic stenosis who are candidates for transcatheter aortic valve implantation.

(BASEC)

Sponsor

Rede Optimus Hospitalar AG

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

(BASEC)

Datum der Bewilligung durch die Ethikkommission

13.06.2025

(BASEC)

Ergebnisse der Studie