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Recruiting NCT06493994

Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry

— Observational Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transaxillary (TAX) transcatheter aortic valve replacement.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).

Interventions

  • Other transaxillary (TAX) transcatheter aortic valve replacement
    Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).

Primary outcome measures

  • Time until first occurrence [Time frame: 30 Days]

Eligibility criteria

Inclusion criteria

  • Patient has been treatet transaxillary (TAX) with Myval transcatheter aortic valve replacement
  • BMI <35 kg/m2
  • Ability to give informed consent

Exclusion criteria

  • History of coronary artery bypass graft and a patent left internal mammary artery (LIMA)
  • Age ≤18 years
  • Patients presenting with pregnancy
  • Patients without informed consent
  • Expected life expectancy <2 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Germany · 1 center
  • Universität zu Lübeck — Lübeck

Identifiers

NCT: NCT06493994 · 2024-240

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗