Aortic Valve Stenosis
Conditions
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).
Interventions
OTHERtransaxillary (TAX) transcatheter aortic valve replacement
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).
Sponsors
University Hopsital Schleswig Holstein Campus Lübeck
University of Luebeck
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
Primary ContactIngo Eitel, Prof. Dr.
Backup ContactRoza Saraei, Dr.
Outcome results
None listed