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NCT Number: NCT06493994

Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry

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).

Recruiting

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universität zu Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location status: Recruiting

Location contact

Ingo Eitel, Prof. Dr. med.

CONTACT

Thomas Stiermaier, Prof. Dr. med.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transaxillary (TAX) transcatheter aortic valve replacement

Other

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 outcomes

  1. Time until first occurrence

    Time frame: 30 Days

    • Stroke including ischemic or hemorrhagic stroke,
    • Systemic embolism,
    • Major bleeding (BARC type 3-5), or Cardiovascular or unexplained death

Study contacts

Contact information is provided by the study sponsor or research team.

Ingo Eitel, Prof. Dr.

CONTACT

[email protected]

+49451500444501

Roza Saraei, Dr.

CONTACT

[email protected]

+4945150044542

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Collaborators

  • University Hopsital Schleswig Holstein Campus Lübeck

Registry information

Acronym: MYVAL-TAX-TAVR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2024
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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