Magna Mitral - 23mm

Study Overview
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Brief Summary
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The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve.

Detailed Description
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This is a prospective, non-randomized, multi-site, descriptive study. A minimum of 15 and up to 20 subjects will be implanted at a minimum of 2 and up to 8 participating investigational sites within the US and internationally.

Official Title
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Clinical Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX

Conditions
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Mitral Heart Valve Disease

Intervention / Treatment
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* Device: Implantation of CEP Magna Mitral Model 7000TFX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has mitral valve disease requiring surgical replacement Patient has provided written informed consent prior to mitral valve surgery Patient is expected to survive surgery and be discharged Patient is willing to comply with specified follow-up evaluations Patient is 13 years of age or older Exclusion Criteria: Patient has life expectancy < 12 months due to non-cardiac co-morbid conditions; Patient has/had active endocarditis within the last 3 months Patient requires replacement of a native or previously implanted prosthetic, tricuspid, pulmonic or aortic valve; Patient was previously enrolled and implanted in the study Patient has/had prior aortic, tricuspid and/ or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ Patient has a body surface area (BSA) > 1.9m2 Female patients who are pregnant, planning to become pregnant, or lactating Patient has a documented history of substance ( drug or alcohol) abuse Patient is currently a prison inmate Patient is currently participating in an investigational drug or another device study Patient is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism Patient has active myocarditis Patient has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event and has not returned to baseline or stabilized > 30 days prior to the planned v alve implant surgery Patient has an abnormality such as an aortic aneurysm (e.g. due to cystic medial necrosis or Marfan's syndrome), aortic dissection, or ventricular aneurysm that might place

Ages Eligible for Study
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Minimum Age: 13 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: All subjects receive implant<br>Subjects serve as own control | Device: Implantation of CEP Magna Mitral Model 7000TFX<br>* Heart valve surgery: CEP Magna Mitral Model 7000 TFX<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Early Adverse Events Divided | Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100. | Events occuring within 30 days of procedure | 
| Percent 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 5 years post-implant | 
| Percentage 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. | >30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | 
| Subject's Average Effective Orifice Area (EOA) Measurement | Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time. | Pre-procedure and 1 Year post-Implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral Valve Replacement, 23mm CEP, Magna