Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
ConditionAortic Valve Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEdwards Lifesciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Edwards INSPIRIS RESILIA Aortic Valve
DeviceSurgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Edwards INSPIRIS RESILIA Aortic Valve1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months2
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.
Time frame
Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months3
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.
Time frame
Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months4
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.
Time frame
Prior to discharge (an average of 7 to 10 days after surgery) and at 3 monthsSecondary 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.
Time frame
Baseline and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov