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NCT07120048
Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
Conditions: Aortic Valve Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 500
Sponsor: Edwards Lifesciences
Location: Universitätsklinikum Heidelberg Heidelberg Baden-Wurttemberg
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 Criteria
Inclusion Criteria:
1. Patients requiring an aortic valve replacement using the INSPIRIS RESILIA aortic valve according to its intended purpose
2. Patients with standard-of-care pre-procedure imaging evaluation (echocardiography and CT) data available
3. Age ≥ 18 years
4. Provision of written informed consent
Exclusion Criteria:
1. Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
2. Emergency procedure
3. Patients requiring a non-aortic heart valve procedure during the index procedure
Source: ClinicalTrials.gov (NCT07120048). StuddyBuddy aggregates publicly available trial information.