SAVR: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.
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.
The INSPIRIS RESILIA Aortic Valve™ is a stented tri-leaflet valve comprised of bovine
 pericardial tissue. The tissue is created by treating bovine pericardial tissue with Edwards
 Integrity Preservation. It incorporates a stable capping anticalcification process, which
 blocks residual aldehyde groups known to bind with calcium. Tissue preservation with glycerol
 allows the valve to be stored without a traditional liquid-based solution, such as
 glutaraldehyde. Therefore, valve is stored under dry packaging conditions and consequently
 does not require rinsing prior to implantation.

 The novel tissue preservation technology significantly improves hemodynamic and
 anticalcification properties compared with the standard Perimount valve in an ovine model
 (Flameng et al., 2015). The RESILIA tissue has been studied in the COMMENCE trial: Two year
 data show that the NYHA class improved in 65.7% of patients, effective orifice area after
 implantation was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmHg; and paravalvular leak was
 none/trivial in 94.5% of patients (mild to moderate in 0.5%) (Puskas et al., 2017).

 On the sizes 19 - 25 mm the INSPIRIS RESILIA Aortic Valve™ has been outfitted with the VFit
 technology, which incorporates two novel features designed for potential future
 valve-in-valve procedures: fluoroscopically visible size markers and an expandable cobalt
 chromium alloy band. No clinical data are available that evaluate the use of the INSPIRIS
 RESILIA Aortic Valve™ in patients to date.
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