Actively Recruiting

Age: 18Years +
All Genders
ID06493994

Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry

Led by University of Luebeck · Updated on 2025-01-03

100

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

Sponsors

U

University of Luebeck

Lead Sponsor

U

University Hopsital Schleswig Holstein Campus Lübeck

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the Myval transcatheter heart valve (THV) in patients treated for aortic valve stenosis using transaxillary (TAX) transcatheter aortic valve replacement (TAVR). The study aims to assess how feasible and safe this procedure is, as well as its procedural success and potential benefits. Participants will undergo the transaxillary TAVR procedure using the Myval THV. The study collects data from multiple centers to understand outcomes related to this technique. During the study, researchers will monitor the time until the first occurrence of specific clinical events within 30 days after the procedure. Participants will be followed closely to assess safety and procedural success, with ongoing evaluation during this period.

CONDITIONS

Official Title

Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient has been treated transaxillary (TAX) with Myval transcatheter aortic valve replacement
  • BMI <35 kg/m2
  • Ability to give informed consent
Not Eligible

You will not qualify if you...

  • History of coronary artery bypass graft and a patent left internal mammary artery (LIMA)
  • Age �318 years
  • Patients presenting with pregnancy
  • Patients without informed consent
  • Expected life expectancy <2 years

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universität zu Lübeck

Lübeck, Schleswig-Holstein, Germany, 23538

Actively Recruiting

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Research Team

I

Ingo Eitel, Prof. Dr.

R

Roza Saraei, Dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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