Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
Recruiting now
Conditions studied: Aortic Valve Disease
In brief
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.
Key facts
- Study ID
- NCT07120048
- Run by
- Edwards Lifesciences
- People needed
- 500
- Starts
- 2025-07-30
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Universitätsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
- Rhön Klinikum Campus Bad Neustadt — Bad Neustadt an der Saale, Bavaria, Germany (enrolling)
- Universitätsklinikum Erlangen — Erlangen, Bavaria, Germany (enrolling)
- LMU Klinikum München — Munich, Bavaria, Germany (enrolling)
- TUM Klinikum Deutsches Herzzentrum — Munich, Bavaria, Germany (enrolling)
- Klinikum Passau — Passau, Bavaria, Germany (enrolling)
- Klinikum Oldenburg — Oldenburg, Lower Saxony, Germany (enrolling)
- Herz- und Diabeteszentrum NRW — Bad Oeynhausen, North Rhine-Westphalia, Germany (enrolling)
- Helios Universitätsklinikum Wuppertal — Wuppertal, North Rhine-Westphalia, Germany (enrolling)
- Herzzentrum Dresden — Dresden, Saxony, Germany (enrolling)
- Herzzentrum Leipzig — Leipzig, Saxony, Germany (enrolling)
- UKSH Universitätsklinikum Schleswig-Holstein, Campus Kiel — Kiel, Schleswig-Holstein, Germany (enrolling)
- Universitätsklinikum Jena — Jena, Thuringia, Germany (enrolling)
- Deutsches Herzzentrum der Charité Berlin — Berlin, Germany (enrolling)
Full record on ClinicalTrials.gov
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