Clinical trial Recruiting at 1 site Observational Ages 18 and up

Using Myval heart valves for aortic valve replacement through the armpit

Official title: Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry

Run by University of Luebeck · NCT06493994 · Data updated 2026-11-12

This study is testing if using the Myval heart valve for aortic valve replacement through the armpit is safe and effective for people with aortic valve stenosis.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversity of Luebeck
Academic / other
Locations1 site (Lübeck, Schleswig-Holstein)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedJanuary 30, 2027
Study endsJanuary 30, 2027
Registry record updatedJanuary 3, 2025
Trial IDNCT06493994 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with aortic valve stenosis who are undergoing transaxillary TAVR with the Myval valve and have a BMI under 35.

Probably not a fit

Patients with a history of coronary artery bypass grafting or those with a life expectancy of less than two years may not benefit from this study.

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 aims to evaluate the feasibility, procedural success, safety, and potential benefits of the Myval transcatheter heart valve in patients undergoing transaxillary transcatheter aortic valve replacement (TAVR) for aortic valve stenosis. It involves monitoring patients who have received the Myval valve through a minimally invasive approach. The study will collect data on outcomes and experiences to better understand the effectiveness of this technique.

Why it matters

Potential benefit: If successful, this approach could provide a safer and less invasive option for patients with aortic valve stenosis.

How similar studies have gone: Other studies have shown promise with transcatheter aortic valve replacement techniques, suggesting potential for success with this approach.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Universität zu Lübeck
    Lübeck, Schleswig-Holstein, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.