NCT07215143 Observational Study to Collect Data of Patient Which Recieving a TAVI in TAVI Procedure
| NCT ID | NCT07215143 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IHF GmbH - Institut für Herzinfarktforschung |
| Condition | Aortic Valve Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2033-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2026-05-12 with a primary completion date of 2033-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07215143 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07215143 currently recruiting?
Yes, NCT07215143 is actively recruiting participants. Visit ClinicalTrials.gov or contact IHF GmbH - Institut für Herzinfarktforschung to inquire about joining.
Where is the NCT07215143 trial being conducted?
This trial is being conducted at Freiburg im Breisgau, Germany.
Who is sponsoring the NCT07215143 clinical trial?
NCT07215143 is sponsored by IHF GmbH - Institut für Herzinfarktforschung. The trial plans to enroll 300 participants.