Magna Mitral - 23mm

Completed · Not applicable

Conditions studied: Mitral Heart Valve Disease

In brief

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.

Key facts

Study ID

NCT01312779

Run by

Edwards Lifesciences

People needed

39

Starts

2011-03-01

Expected to finish

2018-11-01

Last updated by the study team

2020-03-18

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Cooper University Hospital — Camden, New Jersey, United States
• The John Paul II Hospital in Krakow — Krakow, Poland

Full record on ClinicalTrials.gov

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