Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry

Recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT06493994
• Lead Sponsor: University of Luebeck

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-02
• Study First Posted: 2024-07-10
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2027-01-30
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time until first occurrence	30 Days	* Stroke including ischemic or hemorrhagic stroke,; * Systemic embolism,; * Major bleeding (BARC type 3-5), or Cardiovascular or unexplained death

Trial Locations

Locations (1)

Universität zu Lübeck; 🇩🇪 Lübeck, Schleswig-Holstein, Germany