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Observational Study to Collect Data of Patient Which Recieving a TAVI in TAVI Procedure
Sponsor: IHF GmbH - Institut für Herzinfarktforschung
Summary
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.
Official title: Transcatheter Aortic Valve Implantation With Myval THV (OCTACOR/OCTAPRO) in Patients With a Failing Successfully Im-planted First Transcatheter Heart Valve
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2026-04
Completion Date
2033-06
Last Updated
2026-03-24
Healthy Volunteers
No