Status:
NOT_YET_RECRUITING
Observational Study to Collect Data of Patient Which Recieving a TAVI in TAVI Procedure
Lead Sponsor:
IHF GmbH - Institut für Herzinfarktforschung
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief 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 pro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Participation in an interventional clinical trial
- Limited life expectancy \<12 months
- Foreseeable problems in performing follow-up visits
Key Trial Info
Start Date :
January 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2033
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07215143
Start Date
January 1 2026
End Date
June 1 2033
Last Update
October 10 2025
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