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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• LMU Klinikum München
  Munich, Bavaria, Germany Recruiting
• TUM Klinikum Deutsches Herzzentrum
  Munich, Bavaria, Germany Recruiting
• Klinikum Passau
  Passau, Bavaria, Germany Recruiting

Study contacts

• Principal investigator: Torsten Doenst, Prof. Dr. med. — Jena University Hospital, University of Jena
• Study coordinator: Sabrina Hundt, PhD
• Email: sabrina_hundt@edwards.com
• Phone: +49 151 67550601

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.