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

Not yet recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT07215143
• Lead Sponsor: IHF GmbH - Institut für Herzinfarktforschung

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-10
• Last Update Posted: 2025-10-10
• Study Start: 2026-01-01
• Primary Completion: 2033-01
• Study Completion: 2033-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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 Criteria

• Participation in an interventional clinical trial
• Limited life expectancy <12 months
• Foreseeable problems in performing follow-up visits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VARC-3 (Valve Academic Research Consortium Version 3))	at 30 days