Observational Study to Collect Data of Patient Which Recieving a TAVI in TAVI Procedure

Patients with aortic valve stenosis often undergo transcatheter aortic valve implantation (TAVI) today. This biological valve can wear out or leak over time. In such cases, a second catheter-based procedure may be necessary, in which a new valve is inserted into the old one - a so-called TAVI-in-TAVI procedure. This method is considered a gentle alternative to repeat open heart surgery. The trial will include around 300 patients from several European centres who are scheduled to undergo or have already undergone a TAVI-in-TAVI procedure with the Myval valve. Participation includes follow-up observation for a period of up to five years. Data collection will take place exclusively within the framework of regular medical care. This includes information on pre-existing conditions, the procedure, complications and subsequent hospital stays. Imaging examinations such as echocardiography or CT scans can also be centrally evaluated if they are performed routinely.

NCT Number	NCT07215143
Lead Sponsor	IHF GmbH - Institut für Herzinfarktforschung
Conditions	Aortic Valve Stenosis
Enrollment	300 participants
Start Date	2026-04
Primary Completion	2033-01 (estimated)
Study Completion	2033-06 (estimated)
Updated on ClinicalTrials.gov	2026-03-24