TAVI-in-TAVI with Myval: following patients who had a prior TAVI to see how they do over time
Official title: Transcatheter Aortic Valve Implantation With Myval THV (OCTACOR/OCTAPRO) in Patients With a Failing Successfully Im-planted First Transcatheter Heart Valve
Run by IHF GmbH - Institut für Herzinfarktforschung · NCT07215143 · Data updated 2026-11-12
This study follows about 300 adults who are undergoing or have had a TAVI-in-TAVI procedure with the Myval valve to see how they fare over up to five years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | IHF GmbH - Institut für Herzinfarktforschung Academic / other |
| Locations | 1 site (Freiburg im Breisgau) |
| Status | Recruiting |
| Started | May 12, 2026 |
| Main results expected | January 2033 |
| Study ends | June 2033 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07215143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who are planned for, have undergone, or attempted a TAVI-in-TAVI with a Myval valve in a previously implanted valve (≥3 months prior).
✕Probably not a fit
Patients with limited life expectancy (<12 months) or those unlikely to attend follow-up may not benefit from this observational data.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects data from patients undergoing TAVI-in-TAVI with the Myval valve across several European centers. It relies on information from routine medical care, including prior conditions, the procedure details, complications, hospital stays, and routinely performed imaging. The goal is to understand real-world outcomes and long-term follow-up after a second catheter-based valve in a previously implanted valve. Imaging assessments such as echocardiography or CT may be evaluated if performed as part of standard care. Follow-up is planned for up to five years.
Why it matters
Potential benefit: If successful, the study could clarify long-term safety and durability of TAVI-in-TAVI with Myval and inform future patient management.
How similar studies have gone: Previous studies in TAVI-in-TAVI approaches have reported varied outcomes; this trial adds real-world European experience with a specific Myval valve.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Universitätsklinikum Freiburg/Bad Krozingen
Freiburg im Breisgau, Germany Recruiting
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.