Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Aortic Valve Stenosis trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorIHF GmbH - Institut für Herzinfarktforschung
Academic / other
Locations1 site (Freiburg im Breisgau)
StatusRecruiting
StartedMay 12, 2026
Main results expectedJanuary 2033
Study endsJune 2033
Registry record updatedNovember 9, 2026
Trial IDNCT07215143 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

  • Universitätsklinikum Freiburg/Bad Krozingen
    Freiburg im Breisgau, Germany
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.