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.

NCT Number	NCT04053088
Lead Sponsor	Institut für Pharmakologie und Präventive Medizin Collaborators: Edwards Lifesciences
Conditions	Cardiovascular Diseases
Enrollment	500 participants
Start Date	2019-12-12
Primary Completion	2026-10-01 (estimated)
Study Completion	2027-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-30