- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01171625
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Innsbruck, Austria, 6020
- Universitatslinik fur Chirurgie
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Vancouver, Canada, V6Z 1Y6
- St. Paul's Hospital
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Hannover, Germany, D-30625
- Klinik fur Herz-, Thorax-, Transplantations- und Gefabchirurgie
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Lazarettstr
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Munich, Lazarettstr, Germany, 36
- Liknik fur Herz und BefaBchirurgie Im Deuschen Herzzentrum
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Madrid
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San Martin de Porres 4, Madrid, Spain, CP-28035
- Hospital Peutra de Hierro
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Cambridge
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Papworth Everard, Cambridge, United Kingdom, CV23 3RE
- Papworth Hospital NHS Foundation Trust
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Lancashire
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Blackpool, Lancashire, United Kingdom, FY8 8NR
- Blackpool Victoria Hospital
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California
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Sacramento, California, United States, 95819
- Mercy General Hospital
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper University Hospital
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Morristown, New Jersey, United States, 09762
- Morristown Memorial Hospital
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Oregon
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Portland, Oregon, United States, 97225
- Providence Heart & Vascular Institute
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Utah
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Salt Lake City, Utah, United States, 84124
- St. Marks Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: CEP Aortic Bioprothesis, model 3300TFX
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Heart Valve Surgery
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject's Percentage of Long Term Safety Performance
Time Frame: 31 days through 8 years post-implant
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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
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Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant
Time Frame: 8 years post-implant
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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
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Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline
Time Frame: 8 Years post-implant
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Early Adverse Events
Time Frame: Events occurring within 30 days of procedure
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Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
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Events occurring within 30 days of procedure
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Percentage of Late Adverse Events
Time Frame: Events occurring >= 31 days and up through 8 years post-implant
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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).
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Events occurring >= 31 days and up through 8 years post-implant
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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
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Subject's freedom from Serious Adverse Events at > 30 days post-implant.
Time to events were estimated by Kaplan-Meier method.
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1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant
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Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant
Time Frame: 8 years post-implant
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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.
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8 years post-implant
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Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant.
Time Frame: 8 years post-implant
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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.
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8 years post-implant
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Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant.
Time Frame: 8 years post-implant
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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.
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8 years post-implant
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Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant.
Time Frame: 8 years post-implant
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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.
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8 years post-implant
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Subject's Average Performance Index Measurements at 8 Years Post-implant.
Time Frame: 8 years post-implant
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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.
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8 years post-implant
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Subject's Average Cardiac Output Measurements at 8 Years Post-implant.
Time Frame: 8 years post-implant
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The amount of blood the heart pumps through the circulatory system in a minute.
The data summary will be stratified by valve size.
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8 years post-implant
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Subject's Average Cardiac Index Measurements at 8 Years Post-implant.
Time Frame: 8 years post-implant
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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.
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8 years post-implant
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Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant.
Time Frame: 8 years post-implant
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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.
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8 years post-implant
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Subject's Average White Blood Cell Count Measurement Over Time.
Time Frame: 6 months and annually for 8 years post-implant
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Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
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6 months and annually for 8 years post-implant
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Subject's Average Red Blood Cells Count Over Time.
Time Frame: 6 months and annually for 8 years post-implant
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Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.
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6 months and annually for 8 years post-implant
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Subject's Average Hematocrit Percentage Over Time.
Time Frame: 6 months and annually for 8 years post-implant
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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.
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6 months and annually for 8 years post-implant
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Subject's Average Hemoglobin Count Over Time.
Time Frame: 6 months and annually for 8 years post-implant
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Laboratory Analysis of Hemoglobin Count on blood drawn from subjects.
Hemoglobin is an oxygen-carrying protein in red blood cells.
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6 months and annually for 8 years post-implant
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Subject's Average Platelet Count Over Time.
Time Frame: 6 months and annually for 8 years post-implant
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Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
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6 months and annually for 8 years post-implant
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Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time.
Time Frame: 6 months and annually for 8 years post-implant
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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.
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6 months and annually for 8 years post-implant
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Subject's Average Haptoglobin Measurement Over Time.
Time Frame: 6 months and annually for 8 years post-implant
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Laboratory Analysis of haptoglobin on blood drawn from subjects; haptoglobin is a protein produced by the liver.
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6 months and annually for 8 years post-implant
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Subject's Average Reticulocytes Percentage Over Time.
Time Frame: 6 months and annually for 8 years post-implant
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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.
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6 months and annually for 8 years post-implant
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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
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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'.
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Baseline and 6 Months Post-Implant
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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