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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Heart valve surgery: CEP Magna Mitral Model 7000 TFX
Florida Hospital
Orlando, Florida, United States
Northwestern Hospital
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Washington University
St Louis, Missouri, United States
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.
Time frame: 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).
Time frame: 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.
Time frame: >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.
Time frame: Pre-procedure and 1 Year post-Implant
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Cooper University Hospital
Camden, New Jersey, United States
The John Paul II Hospital in Krakow
Krakow, Poland