Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry

NCT06493994 | Recruiting

• 1 other identifier: 2024-240
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patient has been treatet transaxillary (TAX) with Myval transcatheter aortic valve replacement
• BMI \<35 kg/m2
• Ability to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Luebeck: lead
• University Hopsital Schleswig Holstein Campus Lübeck: collaborator

Study Sites (1)

Universität zu Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Taxes; Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Ingo Eitel, Prof. Dr.

CONTACT

+49451500444501; ingo.eitel@uksh.de

Roza Saraei, Dr.

CONTACT

+4945150044542; roza.saraei@uksh.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the MKII

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)