Real-world outcomes of the INSPIRIS RESILIA aortic valve in adults

A Prospective, Observational Registry Study Designed to Collect Real-world Hemodynamic and Clinical Outcomes of the INSPIRIS RESILIA Aortic Valve

This registry will collect real-world data to see how the INSPIRIS RESILIA aortic valve performs in adults undergoing aortic valve replacement.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Edwards Lifesciences (Industry-sponsored)
• Locations: 11 sites (Heidelberg, Baden-Wurttemberg and 10 other locations)
• Trial ID: NCT07120048 on ClinicalTrials.gov

What this trial studies

INDICATE is an observational registry enrolling up to 500 adults at multiple sites in Germany who receive the INSPIRIS RESILIA aortic valve (Model 11500A) as their only valve procedure. The registry will capture perioperative, hemodynamic, and clinical outcome data using standard-of-care imaging (echocardiography and CT) and routine follow‑up. Enrollment excludes emergency procedures and patients with active or recent endocarditis/myocarditis, and it does not include patients having non‑aortic valve surgery during the index operation. Collected data will be used to characterize real-world device performance and safety across participating centers.

Who should consider this trial

Good fit: Adults (≥18 years) scheduled for a non-emergency aortic valve replacement who will receive the INSPIRIS RESILIA valve, have standard pre-procedure imaging available, and can give written informed consent.

Not a fit: Patients with active or recent endocarditis/myocarditis, those needing emergency procedures, or those requiring additional non‑aortic valve surgery are excluded and would not be expected to benefit from participation.

Why it matters

Potential benefit: If successful, the registry could give patients and clinicians clearer, real-world information about the valve's hemodynamic performance and clinical safety to guide treatment choices.

How similar studies have performed: Other observational registries and clinical studies of bioprosthetic aortic valves have provided useful real-world safety and performance data, though long-term device-specific durability data for the INSPIRIS RESILIA valve are still being collected.

Eligibility criteria

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

Where this trial is running

Heidelberg, Baden-Wurttemberg and 10 other locations

• Universitätsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
• Rhön Klinikum Campus Bad Neustadt — Bad Neustadt an der Saale, Bavaria, Germany (Recruiting)
• Universitätsklinikum Erlangen — Erlangen, Bavaria, Germany (Recruiting)
• TUM Klinikum Deutsches Herzzentrum — Munich, Bavaria, Germany (Recruiting)
• Klinikum Passau — Passau, Bavaria, Germany (Recruiting)
• Klinikum Oldenburg — Oldenburg, Lower Saxony, Germany (Recruiting)
• Herzzentrum Dresden — Dresden, Saxony, Germany (Recruiting)
• Herzzentrum Leipzig — Leipzig, Saxony, Germany (Recruiting)
• UKSH Universitätsklinikum Schleswig-Holstein, Campus Kiel — Kiel, Schleswig-Holstein, Germany (Recruiting)
• Universitätsklinikum Jena — Jena, Thuringia, Germany (Recruiting)
• Deutsches Herzzentrum der Charité Berlin — Berlin, Germany (Recruiting)

Study contacts

• Principal investigator: Torsten Doenst, Prof. Dr. med. — Jena University Hospital, University of Jena
• Study coordinator: Sabrina Hundt, PhD

Conditions Aortic Valve Disease