Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry (MYVAL-TAX-TAVR)

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).

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Other: transaxillary (TAX) transcatheter aortic valve replacement

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ingo Eitel, Prof. Dr.; Phone Number: +49451500444501; Email: ingo.eitel@uksh.de
• Study Contact Backup: Name: Roza Saraei, Dr.; Phone Number: +4945150044542; Email: roza.saraei@uksh.de

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Recruiting
      • Universität zu Lübeck
      • Contact: Ingo Eitel, Prof. Dr. med.
      • Contact: Thomas Stiermaier, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who were treated with Myval TAVR via TAX access are included in the registry.

The participating centers also provide a retrospective cohort of TAX-TAVR implantations with other TAVR prothesis (e.g. Edwards Sapien XT/3/Ultra, Medtronic Evolut R/Pro, Accurate Neo, Allegra, Portico) to compare the results and outcomes of the MYVAL-TAX-TAVR registry using the Myval THV with other TAVR bioprothesis used for TAX-TAVR. To further improve comparability between groups propensity score matching between the groups will be performed using the following parameters (age, sex, STS score, peripheral artery disease, atrial fibrillation, minimum axillary diameter, moderate/severe axillary tortuosity and moderate/severe axillary, calcification).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Luebeck
• Collaborators: University Hopsital Schleswig Holstein Campus Lübeck

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2024-240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No