Phase
Condition
Cardiac Disease
Hypercholesterolemia
Thrombosis
Treatment
Implantation of CEP Magna Ease Model 3300TFX
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The patient requires, as indicated in the preoperative evaluation, a replacementaortic valve.
The patient is an average or better operative risk.
The patient is geographically stable and agrees to attend follow-up assessments at thehospital 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
Exclusion Criteria:
The patient has any known non-cardiac life-threatening disease, which will limit thepatient'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 medialnecrosis, 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 ordevice.
The patient requires replacement of a native or prosthetic mitral, tricuspid orpulmonic valve.
The patient requires a repair of the mitral or tricuspid valve with the use of anannuloplasty device.
The patient was previously enrolled in the study.
The patient had a prior mitral, tricuspid or pulmonic valve surgery, which includedimplantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring thatwill remain in situ.
Study Design
Study Description
Connect with a study center
Universitatslinik fur Chirurgie
Anichstr. 35, Innsbruck 6020
AustriaSite Not Available
Universitatslinik fur Chirurgie
Innsbruck, 6020
AustriaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaSite Not Available
St. Paul's Hospital
Vancouver, V6Z 1Y6
CanadaSite Not Available
Liknik fur Herz und BefaBchirurgie Im Deuschen Herzzentrum
Munich, Lazarettstr 36
GermanySite Not Available
Klinik fur Herz-, Thorax-, Transplantations- und Gefabchirurgie
Hannover, D-30625
GermanySite Not Available
Hospital Peutra de Hierro
San Martin de Porres 4, Madrid CP-28035
SpainSite Not Available
Papworth Hospital NHS foundation Trust
Papworth Everard, Cambridge CV23 3RE
United KingdomSite Not Available
Blackpool Victoria Hospital
Blackpool, Lancashire FY8 8NR
United KingdomSite Not Available
University of Arizona
Tucson, Arizona 85724
United StatesSite Not Available
Mercy General Hospital
Sacramento, California 95819
United StatesSite Not Available
Cooper University Hospital
Camden, New Jersey 08103
United StatesSite Not Available
Morristown Memorial Hospital
Morristown, New Jersey 09762
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Providence Heart & Vascular Institute
Portland, Oregon 97225
United StatesSite Not Available
St. Marks Hospital
Salt Lake City, Utah 84124
United StatesSite Not Available

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