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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01171625
Recruitment Status : Completed
First Posted : July 28, 2010
Results First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Aortic Valve Disorder Heart Failure Aortic Valve Stenosis Aortic Valve Insufficiency Device: Implantation of CEP Magna Ease Model 3300TFX Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX
Actual Study Start Date : October 2007
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
CEP Aortic Bioprothesis, model 3300TFX Device: Implantation of CEP Magna Ease Model 3300TFX
Heart Valve Surgery
Other Name: CEP Magna Ease MOdel 3300TFX




Primary Outcome Measures :
  1. Subject's Percentage of Long Term Safety Performance [ Time Frame: 31 days through 8 years post-implant ]

    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).


  2. Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant [ Time Frame: 8 years 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).


  3. Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline [ Time Frame: 8 Years 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).

    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.



Secondary Outcome Measures :
  1. Percent of Early Adverse Events [ Time Frame: Events occurring within 30 days of procedure ]
    Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.

  2. Percentage of Late Adverse Events [ Time Frame: Events occurring >= 31 days and up through 8 years post-implant ]
    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).

  3. Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days [ Time Frame: 1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant ]
    Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method.

  4. Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant [ Time Frame: 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.

  5. Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant. [ Time Frame: 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.

  6. Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant. [ Time Frame: 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.

  7. Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant. [ Time Frame: 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. Subject's Average Performance Index Measurements at 8 Years Post-implant. [ Time Frame: 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.

  9. Subject's Average Cardiac Output Measurements at 8 Years Post-implant. [ Time Frame: 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.

  10. Subject's Average Cardiac Index Measurements at 8 Years Post-implant. [ Time Frame: 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.

  11. Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant. [ Time Frame: 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.

  12. Subject's Average White Blood Cell Count Measurement Over Time. [ Time Frame: 6 months and annually for 8 years post-implant ]
    Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.

  13. Subject's Average Red Blood Cells Count Over Time. [ Time Frame: 6 months and annually for 8 years post-implant ]
    Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.

  14. Subject's Average Hematocrit Percentage Over Time. [ Time Frame: 6 months and annually for 8 years post-implant ]
    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.

  15. Subject's Average Hemoglobin Count Over Time. [ Time Frame: 6 months and annually for 8 years post-implant ]
    Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.

  16. Subject's Average Platelet Count Over Time. [ Time Frame: 6 months and annually for 8 years post-implant ]
    Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.

  17. Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. [ Time Frame: 6 months and annually for 8 years post-implant ]
    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.

  18. Subject's Average Haptoglobin Measurement Over Time. [ Time Frame: 6 months and annually for 8 years post-implant ]
    Laboratory Analysis of haptoglobin on blood drawn from subjects; haptoglobin is a protein produced by the liver.

  19. Subject's Average Reticulocytes Percentage Over Time. [ Time Frame: 6 months and annually for 8 years post-implant ]
    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.

  20. Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant. [ Time Frame: 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'.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient requires, as indicated in the preoperative evaluation, a replacement aortic valve.
  2. The patient is an average or better operative risk.
  3. The patient is geographically stable and agrees to attend follow-up assessments at the hospital of surgical services for at least 8 years.
  4. The patient is 18 years or older.
  5. The patient has signed and dated the subject informed consent form prior to surgery.

Exclusion Criteria:

  1. The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
  2. The patient presents with active endocarditis within the last 3 months.
  3. The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism).
  4. The patient has an aneurismal aortic degenerative condition (e.g., cystic medial necrosis, Marfan's syndrome).
  5. The patient is pregnant or lactating.
  6. The patient is an intravenous drug abuser.
  7. The patient is currently a prison inmate.
  8. The patient is currently participating in a study of an investigational drug or device.
  9. The patient requires replacement of a native or prosthetic mitral, tricuspid or pulmonic valve.
  10. The patient requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device.
  11. The patient was previously enrolled in the study.
  12. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171625


Locations
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United States, California
Mercy General Hospital
Sacramento, California, United States, 95819
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Morristown Memorial Hospital
Morristown, New Jersey, United States, 09762
United States, Oregon
Providence Heart & Vascular Institute
Portland, Oregon, United States, 97225
United States, Utah
St. Marks Hospital
Salt Lake City, Utah, United States, 84124
Austria
Universitatslinik fur Chirurgie
Innsbruck, Austria, 6020
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada
St. Paul's Hospital
Vancouver, Canada, V6Z 1Y6
Germany
Liknik fur Herz und BefaBchirurgie Im Deuschen Herzzentrum
Munich, Lazarettstr, Germany, 36
Klinik fur Herz-, Thorax-, Transplantations- und Gefabchirurgie
Hannover, Germany, D-30625
Spain
Hospital Peutra de Hierro
San Martin de Porres 4, Madrid, Spain, CP-28035
United Kingdom
Papworth Hospital NHS foundation Trust
Papworth Everard, Cambridge, United Kingdom, CV23 3RE
Blackpool Victoria Hospital
Blackpool, Lancashire, United Kingdom, FY8 8NR
Sponsors and Collaborators
Edwards Lifesciences
  Study Documents (Full-Text)

Documents provided by Edwards Lifesciences:
Additional Information:
Publications of Results:
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01171625    
Other Study ID Numbers: 2007-08
First Posted: July 28, 2010    Key Record Dates
Results First Posted: April 17, 2020
Last Update Posted: April 17, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Edwards Lifesciences:
PERIMOUNT, Aortic valve replacement/regurgitation
Additional relevant MeSH terms:
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Coronary Artery Disease
Aortic Valve Stenosis
Aortic Valve Insufficiency
Aortic Valve Disease
Heart Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction