Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
ConditionAortic Valve Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEdwards Lifesciences
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Edwards INSPIRIS RESILIA Aortic Valve
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov