SAVR: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.

The IMPACT Registry represents a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years that includes data of patients undergoing aortic valve replacement with the Edwards INSPIRIS RESILIA Aortic Valve™. The IMPACT Registry will be performed in up to 25 participating sites across Germany, Austria and Switzerland. A minimum number of 500 patients (20 patients per center) will be enrolled. Patients will undergo follow-up visits at baseline, surgery, pre-discharge, year 1, year 3 and year 5.

Inclusion Criteria: 1. Patient is at least 18 years old 2. Patient has an aortic valve vitium and requires an aortic valve replacement with the Edwards INSPIRIS RESILIA Aortic Valve™ 3. Patient is scheduled to attend yearly follow-up visits at the registry center up to 5 years 4. Patient provides written informed consent prior to the procedure and in case of emergency after the procedure. Exclusion Criteria: 1. Disability and / or other circumstances under which the patient is not capable to understand the nature, significance and scope of the clinical trial 2. Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery 3. Patient has a life expectancy ≤ 12 months for any reason 4. Valve implantation is not possible in accordance with the device IFU 5. Pregnancy