Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX

Completed · Not applicable

Conditions studied: Coronary Artery Disease, Aortic Valve Disorder, Heart Failure, Aortic Valve Stenosis, Aortic Valve Insufficiency

In brief

The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.

Key facts

Study ID

NCT01171625

Run by

Edwards Lifesciences

People needed

283

Starts

2007-10-01

Expected to finish

2018-09-01

Last updated by the study team

2020-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient requires, as indicated in the preoperative evaluation, a replacement aortic valve.
• The patient is an average or better operative risk.
• The patient is geographically stable and agrees to attend follow-up assessments at the hospital 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.

You may not qualify if…

• The patient has any known non-cardiac life-threatening disease, which will limit the patient'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 medial necrosis, 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 or device.
• The patient requires replacement of a native or prosthetic mitral, tricuspid or pulmonic valve.
• The patient requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device.
• The patient was previously enrolled in the study.
• The patient had a prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ.

Where it is running

• Mercy General Hospital — Sacramento, California, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Providence Heart & Vascular Institute — Portland, Oregon, United States
• St. Marks Hospital — Salt Lake City, Utah, United States
• Universitatslinik fur Chirurgie — Innsbruck, Austria
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• St. Paul's Hospital — Vancouver, Canada
• Liknik fur Herz und BefaBchirurgie Im Deuschen Herzzentrum — Munich, Lazarettstr, Germany
• Klinik fur Herz-, Thorax-, Transplantations- und Gefabchirurgie — Hanover, Germany
• Hospital Peutra de Hierro — San Martin de Porres 4, Madrid, Spain
• Papworth Hospital NHS foundation Trust — Papworth Everard, Cambridge, United Kingdom
• Blackpool Victoria Hospital — Blackpool, Lancashire, United Kingdom

Full record on ClinicalTrials.gov

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