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Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
Sponsor: Edwards Lifesciences
Summary
Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure during the index procedure, with or without other concomitant procedures.
Official title: A Prospective, Observational Registry Study Designed to Collect Real-world Hemodynamic and Clinical Outcomes of the INSPIRIS RESILIA Aortic Valve
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2025-07-30
Completion Date
2026-12
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Edwards INSPIRIS RESILIA Aortic Valve
Surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve
Locations (11)
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Rhön Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, Bavaria, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
TUM Klinikum Deutsches Herzzentrum
Munich, Bavaria, Germany
Klinikum Passau
Passau, Bavaria, Germany
Klinikum Oldenburg
Oldenburg, Lower Saxony, Germany
Herzzentrum Dresden
Dresden, Saxony, Germany
Herzzentrum Leipzig
Leipzig, Saxony, Germany
UKSH Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Deutsches Herzzentrum der Charité Berlin
Berlin, Germany