RecruitingNCT07120048

Real World Data Collection on the INSPIRIS RESILIA Aortic Valve

A Prospective, Observational Registry Study Designed to Collect Real-world Hemodynamic and Clinical Outcomes of the INSPIRIS RESILIA Aortic Valve

Sponsor

Edwards Lifesciences

Enrollment

500 participants

Start Date

Jul 30, 2025

Study Type

OBSERVATIONAL

Conditions

Aortic Valve Disease

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Patients requiring an aortic valve replacement using the INSPIRIS RESILIA aortic valve according to its intended purpose
Patients with standard-of-care pre-procedure imaging evaluation (echocardiography and CT) data available
Age ≥ 18 years
Provision of written informed consent

Exclusion Criteria3

Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
Emergency procedure
Patients requiring a non-aortic heart valve procedure during the index procedure

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Interventions

DEVICEEdwards 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

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NCT07120048

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