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Real World Data Collection on the INSPIRIS RESILIA Aortic Valve

RECRUITINGSponsored by Edwards Lifesciences
Actively Recruiting
SponsorEdwards Lifesciences
Started2025-07-30
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07120048

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Aortic Valve DiseaseHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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