Back to resultsCarpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
Primary Purpose
Coronary Artery Disease, Aortic Valve Disorder, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantation of CEP Magna Ease Model 3300TFX
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring PERIMOUNT, Aortic valve replacement/regurgitation
Eligibility Criteria
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.
Sites / Locations
- Mercy General Hospital
- Cooper University Hospital
- Morristown Memorial Hospital
- Providence Heart & Vascular Institute
- St. Marks Hospital
- Universitatslinik fur Chirurgie
- Sunnybrook Health Sciences Centre
- St. Paul's Hospital
- Liknik fur Herz und BefaBchirurgie Im Deuschen Herzzentrum
- Klinik fur Herz-, Thorax-, Transplantations- und Gefabchirurgie
- Hospital Peutra de Hierro
- Papworth Hospital NHS foundation Trust
- Blackpool Victoria Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CEP Aortic Bioprothesis, model 3300TFX
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
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.
Secondary Outcome Measures
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Subject's Average Platelet Count Over Time.
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
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.
Subject's Average Haptoglobin Measurement Over Time.
Laboratory Analysis of haptoglobin on blood drawn from subjects; haptoglobin is a protein produced by the liver.
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.
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'.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01171625
Brief Title
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
Official Title
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 2007 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Aortic Valve Disorder, Heart Failure, Aortic Valve Stenosis, Aortic Valve Insufficiency
Keywords
PERIMOUNT, Aortic valve replacement/regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
283 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CEP Aortic Bioprothesis, model 3300TFX
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Implantation of CEP Magna Ease Model 3300TFX
Other Intervention Name(s)
CEP Magna Ease MOdel 3300TFX
Intervention Description
Heart Valve Surgery
Primary Outcome Measure Information:
Title
Subject's Percentage of Long Term Safety Performance
Description
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).
Time Frame
31 days through 8 years post-implant
Title
Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant
Description
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).
Time Frame
8 years post-implant
Title
Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline
Description
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
8 Years post-implant
Secondary Outcome Measure Information:
Title
Percent of Early Adverse Events
Description
Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
Time Frame
Events occurring within 30 days of procedure
Title
Percentage of Late Adverse Events
Description
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).
Time Frame
Events occurring >= 31 days and up through 8 years post-implant
Title
Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
Description
Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Time Frame
1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant
Title
Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant
Description
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.
Time Frame
8 years post-implant
Title
Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant.
Description
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.
Time Frame
8 years post-implant
Title
Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant.
Description
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.
Time Frame
8 years post-implant
Title
Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant.
Description
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.
Time Frame
8 years post-implant
Title
Subject's Average Performance Index Measurements at 8 Years Post-implant.
Description
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.
Time Frame
8 years post-implant
Title
Subject's Average Cardiac Output Measurements at 8 Years Post-implant.
Description
The amount of blood the heart pumps through the circulatory system in a minute. The data summary will be stratified by valve size.
Time Frame
8 years post-implant
Title
Subject's Average Cardiac Index Measurements at 8 Years Post-implant.
Description
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.
Time Frame
8 years post-implant
Title
Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant.
Description
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.
Time Frame
8 years post-implant
Title
Subject's Average White Blood Cell Count Measurement Over Time.
Description
Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Time Frame
6 months and annually for 8 years post-implant
Title
Subject's Average Red Blood Cells Count Over Time.
Description
Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.
Time Frame
6 months and annually for 8 years post-implant
Title
Subject's Average Hematocrit Percentage Over Time.
Description
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.
Time Frame
6 months and annually for 8 years post-implant
Title
Subject's Average Hemoglobin Count Over Time.
Description
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Time Frame
6 months and annually for 8 years post-implant
Title
Subject's Average Platelet Count Over Time.
Description
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Time Frame
6 months and annually for 8 years post-implant
Title
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time.
Description
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.
Time Frame
6 months and annually for 8 years post-implant
Title
Subject's Average Haptoglobin Measurement Over Time.
Description
Laboratory Analysis of haptoglobin on blood drawn from subjects; haptoglobin is a protein produced by the liver.
Time Frame
6 months and annually for 8 years post-implant
Title
Subject's Average Reticulocytes Percentage Over Time.
Description
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.
Time Frame
6 months and annually for 8 years post-implant
Title
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant.
Description
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'.
Time Frame
Baseline and 6 Months Post-Implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
09762
Country
United States
Facility Name
Providence Heart & Vascular Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
St. Marks Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Universitatslinik fur Chirurgie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Liknik fur Herz und BefaBchirurgie Im Deuschen Herzzentrum
City
Munich
State/Province
Lazarettstr
ZIP/Postal Code
36
Country
Germany
Facility Name
Klinik fur Herz-, Thorax-, Transplantations- und Gefabchirurgie
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Hospital Peutra de Hierro
City
San Martin de Porres 4
State/Province
Madrid
ZIP/Postal Code
CP-28035
Country
Spain
Facility Name
Papworth Hospital NHS foundation Trust
City
Papworth Everard
State/Province
Cambridge
ZIP/Postal Code
CV23 3RE
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY8 8NR
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29912142
Citation
Wahlers TCW, Andreas M, Rahmanian P, Candolfi P, Zemanova B, Giot C, Ferrari E, Laufer G. Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis. Innovations (Phila). 2018 May/Jun;13(3):177-183. doi: 10.1097/IMI.0000000000000509.
Results Reference
result
Links:
URL
https://euroqol.org/eq-5d-instruments/
Description
Measure of Health Status Survey (EQ-5D)
URL
https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure
Description
New York Heart Association Classification
Learn more about this trial
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
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