Real World Data Collection on the INSPIRIS RESILIA Aortic Valve

NCT07120048 | Recruiting

• 1 other identifier: 2025-07
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 11

Brief Summary

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

Aortic Valve Disease

Outcome Measures

Primary Outcomes (4)

• Subject's average mean gradient measurement over time

  Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.

  Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months

• Subject's average peak gradient measurement over time

  Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.

  Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months

• Amount of aortic transvalvular regurgitation in subjects over time

  Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed by four categories, which are "no/trace leak", "a mild leak", "a moderate leak", and "a severe leak". A severe leak indicates a worsening outcome.

  Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months

• Amount of aortic paravalvular regurgitation in subjects over time

  Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed by four categories, which are "no/trace leak", "a mild leak", "a moderate leak", and "a severe leak". A severe leak indicates a worsening outcome.

  Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months

Secondary Outcomes (1)

• Subject's New York Heart Association (NYHA) functional classification at 3 months as compared to baseline.

  Baseline and 3 months

Study Arms (1)

Edwards INSPIRIS RESILIA Aortic Valve

Subjects who were treated with the INSPIRIS RESILIA Aortic Valve

Device: Edwards INSPIRIS RESILIA Aortic Valve

Interventions

Edwards INSPIRIS RESILIA Aortic Valve DEVICE

Surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve

Edwards INSPIRIS RESILIA Aortic Valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects from Germany who meet all the study inclusion criteria and none of the study exclusion criteria who undergo an aortic valve replacement with the Model 11500A heart valve and voluntary sign a consent form to agree to participate in the study.

You may qualify if:

• 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 CT) data available
• Age ≥ 18 years
• Provision of written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (11)

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

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Torsten Doenst, Prof. Dr. med.

  Jena University Hospital, University of Jena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina Hundt, PhD

CONTACT

+49 151 67550601; sabrina_hundt@edwards.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 13, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (11)