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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Edwards INSPIRIS RESILIA Aortic Valve for people with aortic valve disease. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEdwards INSPIRIS RESILIA Aortic Valve

Surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve

Locations(14)

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Rhön Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, Bavaria, Germany

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

LMU Klinikum München

Munich, Bavaria, Germany

TUM Klinikum Deutsches Herzzentrum

Munich, Bavaria, Germany

Klinikum Passau

Passau, Bavaria, Germany

Klinikum Oldenburg

Oldenburg, Lower Saxony, Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Helios Universitätsklinikum Wuppertal

Wuppertal, North Rhine-Westphalia, 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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