NCT07215143

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
86mo left

Started Apr 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Jun 2033

First Submitted

Initial submission to the registry

October 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2033

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2033

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

6.8 years

First QC Date

October 2, 2025

Last Update Submit

March 23, 2026

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • VARC-3 (Valve Academic Research Consortium Version 3))

    at 30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffers from aortic valve stenosis due to an failure of a previous implanted aortic valve.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2025

First Posted

October 10, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

January 1, 2033

Study Completion (Estimated)

June 1, 2033

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share