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.
A TAVI-in-TAVI procedure with implantation of the Myval THV (Oc-taCor/OctaPRO) into a previously implanted (≥3 months) failing transcatheter heart valve of any kind is either planned, has al-ready been performed, or was attempted, based on a clinical indi-cation established by the treating heart team.
Age: 18 years or more
Informed consent has been obtained.
Participation in an interventional clinical trial
Limited life expectancy <12 months
Foreseeable problems in performing follow-up visits
Patients suffers from aortic valve stenosis due to an failure of a previous implanted aortic valve.
Case-control
Prospective
Not listed
VARC-3 (Valve Academic Research Consortium Version 3))
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This trial is not recruiting at the moment. You can still explore other options:
