Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Study Overview
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Brief Summary
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The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

Detailed Description
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This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years.

Official Title
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Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Conditions
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Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure, Coronary Artery Disease

Intervention / Treatment
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* Procedure: Heart Valve Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Require replacement of aortic valve Signed informed consent Willing to return to study site for follow-up visits Exclusion Criteria: Active endocarditis/myocarditis (< 3 months) Myocardial infarction (< 30 days) Renal insufficiency/ End-stage renal disease Life expectancy (< 1 year) Requires multiple valve replacement/repair Requiring emergent aortic valve surgery Pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aortic Bioprosthesis, Model 11000<br>Aortic valve replacement therapy | Procedure: Heart Valve Surgery<br>* Implant of an aortic valve, Model 11000<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100 | Events occurring within 30 days of procedure | 
| Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Number of late events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). | Events occurring >= 31 days and up through 5 years post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Average Mean Gradient Measurements | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. | Baseline through 5-Year (at each scheduled follow-up visit) | 
| Subject's Average Effective Orifice Area Measurements | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. | Baseline through 5-Year (at each scheduled follow-up visit) | 
| Subject's New York Heart Association (NYHA) Functional Class 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. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. | 3-6 Months and 1 through 5 Years compared to baseline | 
| Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. | Baseline and one year follow-up | 
| Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. | Baseline and 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic valve replacement/regurgitation