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NCT Number: NCT07120048

Real World Data Collection on 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.

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Heidelberg, Heidelberg, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Edwards INSPIRIS RESILIA Aortic Valve

Device

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

Primary outcomes

  1. Subject's average mean gradient measurement over time

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

    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.

  2. Subject's average peak gradient measurement over time

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

    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.

  3. Amount of aortic transvalvular regurgitation in subjects over time

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

    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.

  4. Amount of aortic paravalvular regurgitation in subjects over time

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

    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.

Secondary outcomes

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

    Time frame: Baseline and 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sabrina Hundt, PhD

CONTACT

[email protected]

+49 151 67550601

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Acronym: INDICATE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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