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Recruiting 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07120048). StuddyBuddy aggregates publicly available trial information.