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SAVR: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.
Sponsor: Institut für Pharmakologie und Präventive Medizin
Summary
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.
Official title: Surgical Aortic Valve Replacement: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2019-12-12
Completion Date
2026-08-01
Last Updated
2025-06-12
Healthy Volunteers
No
Conditions
Interventions
INSPIRIS RESILIA Aortic Valve™
Collection of patient data from patients undergoing Surgical Aortic Valve Replacement (SAVR) by usage of the INSPIRIS RESILIA aortic valve™
Locations (22)
Medizinische Universität Innsbruck, Uniklinik für Herzchirurgie
Innsbruck, Austria
Kepler Universitätsklinikum Linz
Linz, Austria
• Universitätsklinikum Salzburg, Herzchirurgie, Gefäßchirurgie und endovaskuläre Chirurgie
Salzburg, Austria
• Klinikum Wels-Grieskirchen, Herz-, Gefäß- und Thoraxchirurgie
Wels, Austria
Klinikum Nürnberg
Nuremberg, Bavaria, Germany
Klinikum Passau/Universität Regensburg
Passau, Bavaria, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
• Universitätsklinikum Frankfurt, Thorax-, Herz- und thorakale Gefässchirurgie
Frankfurt am Main, Hesse, Germany
Universitätsklinik für Herzchirurgie
Oldenburg, Lower Saxony, Germany
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
Schüchtermann Klinik
Bad Rothenfelde, North Rhine-Westphalia, Germany
Herzzentrum Bergmannsheil
Bochum, North Rhine-Westphalia, Germany
Klinik für Herzchirurgie UKD
Düsseldorf, North Rhine-Westphalia, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
• Universitätsklinikum Leipzig, Thorax- und Kardiovaskuläre Chirurgie
Leipzig, Saxony, Germany
BundeswehrKrankenhaus Klinik XVII und XVIII
Koblenz, Germany
Helios Klinikum Siegburg
Siegburg, Germany
Universitätsklinikum Ulm
Ulm, Germany
Helios Klinikum Wuppertal
Wuppertal, Germany
Catharina Ziekenhuis, Catharina Hart- en Vaatcentrum
Eindhoven, Netherlands
HerzKlinik Hirslanden, Herz- und thorakale Gefässchirurgie
Zurich, Switzerland
HerzZentrum Hirslanden, Herz- und Gefässchirurgie
Zurich, Switzerland