A prospective, observational registry study designed to collect realworld hemodynamic and clinical outcomes of the INSPIRIS RESILIA aortic valve

A prospective, observational registry study designed to collect realworld hemodynamic and clinical outcomes of the INSPIRIS RESILIA aortic valve - INDICATE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037572

Enrollment

500

Registered

2025-07-29

Start date

2025-07-30

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I35

Interventions

Group 1: Adult subject (18 years an older) requiring an aortic valve replacement using the INSPIRIS RESILIA aortic valve according to its intended purpose

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - 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 computed tomography [CT]) data available - Provision of written informed consent

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Hemodynamic outcomes at discharge and 3 months post-procedure, confirmed by site-reported echocardiography results, stratified by valve sizing strategies	—

Secondary

Measure	Time frame
Clinical Outcomes: improvement of New York Heart Association (NYHA) functional class compared to baseline	—

Countries

Germany

Contacts

Public ContactTorsten Doenst

Universitätsklinikum Jena

ht@med.uni-jena.de+49 3641 9-322901

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026