Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.

Detailed Description
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This is a prospective, single-arm, multi-center, interventional study to be conducted in the US and outside the US (OUS). This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years. The study will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged or malfunctioning natural or prosthetic aortic valve. Patients will be followed and assessed after implant at discharge, 6 months, one year, and annually for a minimum of 8 years.

Official Title
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Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX

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

Intervention / Treatment
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* Device: Implantation of CEP Magna Ease Model 3300TFX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient requires, as indicated in the preoperative evaluation, a replacement aortic valve. The patient is an average or better operative risk. The patient is geographically stable and agrees to attend follow-up assessments at the hospital of surgical services for at least 8 years. The patient is 18 years or older. The patient has signed and dated the subject informed consent form prior to surgery. Exclusion Criteria: The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year. The patient presents with active endocarditis within the last 3 months. The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). The patient has an aneurismal aortic degenerative condition (e.g., cystic medial necrosis, Marfan's syndrome). The patient is pregnant or lactating. The patient is an intravenous drug abuser. The patient is currently a prison inmate. The patient is currently participating in a study of an investigational drug or device. The patient requires replacement of a native or prosthetic mitral, tricuspid or pulmonic valve. The patient requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device. The patient was previously enrolled in the study. The patient had a prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ.

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 |
| --- | --- |
| Other: CEP Aortic Bioprothesis, model 3300TFX<br> | Device: Implantation of CEP Magna Ease Model 3300TFX<br>* Heart Valve Surgery<br>* Other names: CEP Magna Ease MOdel 3300TFX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Percentage of Long Term Safety Performance | Long term safety performance will be evaluated by comparing the linearized yearly rates to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance. Expressed as the Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). | 31 days through 8 years post-implant | 
| Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant | 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). | 8 years post-implant | 
| Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant 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. | 8 Years post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Early Adverse Events | 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 | 
| Percentage of Late Adverse Events | Number of late events divided by the total number of late patient years times 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 8 years post-implant | 
| Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method. | 1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant | 
| Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant | Peak systolic gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. The data summary will be stratified by valve size. | 8 years post-implant | 
| Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant. | Mean systolic gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Mean gradient values depend on the size and type of valve. The data summary will be stratified by valve size. | 8 years post-implant | 
| Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant. | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. The data summary will be stratified by valve size. | 8 years post-implant | 
| Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant. | Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. The data summary will be stratified by valve size. | 8 years post-implant | 
| Subject's Average Performance Index Measurements at 8 Years Post-implant. | Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. The data summary will be stratified by valve size. | 8 years post-implant | 
| Subject's Average Cardiac Output Measurements at 8 Years Post-implant. | The amount of blood the heart pumps through the circulatory system in a minute. The data summary will be stratified by valve size. | 8 years post-implant | 
| Subject's Average Cardiac Index Measurements at 8 Years Post-implant. | Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual. The data summary will be stratified by valve size. | 8 years post-implant | 
| Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant. | Aortic valvular regurgitation occurs when the aortic 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. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. | 8 years post-implant | 
| Subject's Average White Blood Cell Count Measurement Over Time. | Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection. | 6 months and annually for 8 years post-implant | 
| Subject's Average Red Blood Cells Count Over Time. | Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen. | 6 months and annually for 8 years post-implant | 
| Subject's Average Hematocrit Percentage Over Time. | Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood. | 6 months and annually for 8 years post-implant | 
| Subject's Average Hemoglobin Count Over Time. | Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. | 6 months and annually for 8 years post-implant | 
| Subject's Average Platelet Count Over Time. | Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting. | 6 months and annually for 8 years post-implant | 
| Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. | Laboratory Analysis of Serum Lactate Dehydrogenase on blood drawn from subjects; The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues. | 6 months and annually for 8 years post-implant | 
| Subject's Average Haptoglobin Measurement Over Time. | Laboratory Analysis of haptoglobin on blood drawn from subjects; haptoglobin is a protein produced by the liver. | 6 months and annually for 8 years post-implant | 
| Subject's Average Reticulocytes Percentage Over Time. | Laboratory Analysis of reticulocytes on blood drawn from subjects. Reticulocytes are newly produced immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood. | 6 months and annually for 8 years post-implant | 
| Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant. | 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 ranges from a minimum of 0 and a maximum of 100 where zero is the 'worst state imaginable' and 100 is the 'best state imaginable'. | Baseline and 6 Months Post-Implant | 

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