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NOT YET RECRUITING
NCT07215143

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

Sponsor: IHF GmbH - Institut für Herzinfarktforschung

View on ClinicalTrials.gov

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