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



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/31/2018
Start Date:October 2007
End Date:December 2019

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Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX

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.

This is a prospective, single-arm, multi-center, interventional study to be conducted in the
US and outside the US (OUS). This study will enroll a minimum of 225 patients implanted with
the study valve in order to achieve 101 aortic valve replacement subjects each followed for a
minimum of 8 years. The study will include male and female patients, 18 years or older,
requiring replacement for a diseased, damaged or malfunctioning natural or prosthetic aortic
valve. Patients will be followed and assessed after implant annually for a minimum of 8
years.

Inclusion Criteria:

- Primary

- Require replacement aortic valve

- Signed informed consent

Exclusion Criteria:

- Primary

- Active endocarditis (< 3 mths)

- Abnormal Ca metabolism

- Aneurismal aortic degenerative condition
We found this trial at
6
sites
1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Camden, NJ
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1 Innerkoflerstraße
Innsbruck, 6020
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Innsbruck,
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100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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Morristown, NJ
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Portland, Oregon 97220
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Portland, OR
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Sacramento, California 95819
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Sacramento, CA
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Salt Lake City, Utah 84124
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Salt Lake City, UT
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