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RECRUITINGNCT07120048

Real World Data Collection on the INSPIRIS RESILIA Aortic Valve

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 onl...

Lead sponsor: Edwards Lifesciences•11 locations•View source on ClinicalTrials.gov

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Contacts

Sabrina Hundt, PhD

CONTACT

+49 151 67550601 sabrina_hundt@edwards.com

Sponsors

Lead Sponsor

Edwards Lifesciences

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 2, 2026Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment500

Start dateJul 2025

Last updatedApr 2, 2026

Condition

Aortic Valve Disease

Locations shown

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg

Rhön Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, Bavaria

Universitätsklinikum Erlangen

Erlangen, Bavaria

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2026Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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