Real World Data Collection on the INSPIRIS RESILIA Aortic Valve (INDICATE)

Edwards Lifesciences

Status: Enrolling

Conditions: Aortic Valve Disease

Treatments: Device: Edwards INSPIRIS RESILIA Aortic Valve

Study type: Observational

Funder types: Industry

Identifiers

NCT07120048

2025-07

Details and patient eligibility

About

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.

Full description

Subjects in the INDICATE registry study will be enrolled at up to 20 sites in Germany. Up to 500 subjects will be implanted with the INSPIRIS RESILIA Aortic Valve in this registry.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Edwards INSPIRIS RESILIA Aortic Valve

Description:

Subjects who were treated with the INSPIRIS RESILIA Aortic Valve

Treatment:

Device: Edwards INSPIRIS RESILIA Aortic Valve