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 |
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.
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.
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
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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