Aortic Valve DiseaseINDICATENCT07120048
Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
An observational study of Aortic Valve Disease, run by Edwards Lifesciences at 15 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Edwards INSPIRIS RESILIA Aortic Valve
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 15 sitesGermany
- Study dates
- 30 Jul 2025to Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Germany15 sites, 15 recruiting
- Recruiting
Rhön Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, Bavaria
Anno Diegeler, Prof. Dr. med.
- Recruiting
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia
René Schramm, Prof. Dr. med
- Recruiting
Deutsches Herzzentrum der Charité Berlin
Berlin
Jörg Kempfert, Prof. Dr. med.
- Recruiting
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127
Farhad Bakhtiary, Prof. Dr. med.
- Recruiting
Herzzentrum Dresden
Dresden, Saxony
Klaus Matschke, Prof. Dr. med.
- Recruiting
Universitätsklinikum Erlangen
Erlangen, Bavaria
Friedrich Mellert, PD Dr. med.
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg
Rawa Arif, Prof. Dr. med.
- Recruiting
Universitätsklinikum Jena
Jena, Thuringia
Torsten Doenst, Prof. Dr. med.
- Recruiting
UKSH Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein
Gregor Warnecke, Prof. Dr. med.
- Recruiting
Herzzentrum Leipzig
Leipzig, Saxony
Michael Borger, Prof MD
- Recruiting
LMU Klinikum München
Munich, Bavaria
Sven Peterss, Prof. Dr.
- Recruiting
TUM Klinikum Deutsches Herzzentrum
Munich, Bavaria
Stephanie Voss, PD Dr. med
- Recruiting
Klinikum Oldenburg
Oldenburg, Lower Saxony
Andreas Martens, Prof. Dr. med.
- Recruiting
Klinikum Passau
Passau, Bavaria
Robert Balan, Dr. med.
- Recruiting
Helios Universitätsklinikum Wuppertal
Wuppertal, North Rhine-Westphalia
Lisa Müller, Dr. med.
About this study
Official title: A Prospective, Observational Registry Study Designed to Collect Real-world Hemodynamic and Clinical Outcomes of the INSPIRIS RESILIA Aortic Valve
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.
Read the detailed description
Subjects in the INDICATE registry study will be enrolled at up to 20 sites in Germany. Up to 500 subjects will be implanted with the INSPIRIS RESILIA Aortic Valve in this registry.
- Conditions
- Aortic Valve Disease
- Being tested
- Edwards INSPIRIS RESILIA Aortic Valve
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards INSPIRIS RESILIA Aortic ValveDevice
Surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve
| Study group | Role | What they receive |
|---|---|---|
| Edwards INSPIRIS RESILIA Aortic Valve | Subjects who were treated with the INSPIRIS RESILIA Aortic Valve Receives: Device: Edwards INSPIRIS RESILIA Aortic Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start30 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Torsten Doenst, Prof. Dr. med., Principal investigator, Jena University Hospital, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120048
- Sponsor's protocol ID
- 2025-07
- Acronym
- INDICATE
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) with other researchers.