Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 283
- Locations
- 13
- Primary Endpoint
- Subject's Percentage of Long Term Safety Performance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
CEP Aortic Bioprothesis, model 3300TFX
Intervention: Implantation of CEP Magna Ease Model 3300TFX (Device)
Outcomes
Primary Outcomes
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).
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).
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 Outcomes
- Percent of Early Adverse Events(Events occurring within 30 days of procedure)
- Percentage of Late Adverse Events(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(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(8 years post-implant)
- Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant.(8 years post-implant)
- Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant.(8 years post-implant)
- Subject's Average Performance Index Measurements at 8 Years Post-implant.(8 years post-implant)
- Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant.(8 years post-implant)
- Subject's Average Cardiac Output Measurements at 8 Years Post-implant.(8 years post-implant)
- Subject's Average Cardiac Index Measurements at 8 Years Post-implant.(8 years post-implant)
- Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant.(8 years post-implant)
- Subject's Average White Blood Cell Count Measurement Over Time.(6 months and annually for 8 years post-implant)
- Subject's Average Red Blood Cells Count Over Time.(6 months and annually for 8 years post-implant)
- Subject's Average Hematocrit Percentage Over Time.(6 months and annually for 8 years post-implant)
- Subject's Average Hemoglobin Count Over Time.(6 months and annually for 8 years post-implant)
- Subject's Average Platelet Count Over Time.(6 months and annually for 8 years post-implant)
- Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time.(6 months and annually for 8 years post-implant)
- Subject's Average Haptoglobin Measurement Over Time.(6 months and annually for 8 years post-implant)
- Subject's Average Reticulocytes Percentage Over Time.(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.(Baseline and 6 Months Post-Implant)