Actively Recruiting
Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
Led by Edwards Lifesciences · Updated on 2026-04-02
500
Participants Needed
11
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients requiring an aortic valve replacement using the INSPIRIS RESILIA aortic valve
- Patients with standard-of-care pre-procedure imaging evaluation (echocardiography and CT) data available
- Age 18 years or older
- Provision of written informed consent
You will not qualify if you...
- Active endocarditis or myocarditis, or history of these conditions within 3 months before surgery
- Emergency aortic valve replacement procedure
- Patients needing a non-aortic heart valve procedure during the same surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Actively Recruiting
2
Rhön Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, Bavaria, Germany
Actively Recruiting
3
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Actively Recruiting
4
TUM Klinikum Deutsches Herzzentrum
Munich, Bavaria, Germany
Actively Recruiting
5
Klinikum Passau
Passau, Bavaria, Germany
Actively Recruiting
6
Klinikum Oldenburg
Oldenburg, Lower Saxony, Germany
Actively Recruiting
7
Herzzentrum Dresden
Dresden, Saxony, Germany
Actively Recruiting
8
Herzzentrum Leipzig
Leipzig, Saxony, Germany
Actively Recruiting
9
UKSH Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany
Actively Recruiting
10
Universitätsklinikum Jena
Jena, Thuringia, Germany
Actively Recruiting
11
Deutsches Herzzentrum der Charité Berlin
Berlin, Germany
Actively Recruiting
Research Team
S
Sabrina Hundt, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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