Magna Mitral - 23mm

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Percent of Late Adverse Events	Events occurring >= 31 days and up through 5 years post-implant	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 Early Adverse Events Divided	Events occuring within 30 days of procedure	Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days	>30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant	Subject's freedom from Serious Adverse Events at \> 30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Subject's Average Effective Orifice Area (EOA) Measurement	Pre-procedure and 1 Year post-Implant	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.

Secondary Outcome Measures

Name	Time	Method

Locations (6): Florida Hospital
🇺🇸
Orlando, Florida, United States
Northwestern Hospital
🇺🇸
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
🇺🇸
Iowa City, Iowa, United States
Washington University
🇺🇸
Saint Louis, Missouri, United States
Cooper University Hospital
🇺🇸
Camden, New Jersey, United States
The John Paul II Hospital in Krakow
🇵🇱
Krakow, Poland
Florida Hospital
🇺🇸Orlando, Florida, United States