Real World Data Collection on the INSPIRIS RESILIA Aortic Valve

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Edwards INSPIRIS RESILIA Aortic Valve

Subjects who were treated with the INSPIRIS RESILIA Aortic Valve

Edwards INSPIRIS RESILIA Aortic Valve

Intervention Type DEVICE

Surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve

Interventions

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Edwards INSPIRIS RESILIA Aortic Valve

Surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No