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.

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

sites

Universitatslinik fur Chirurgie

1 Innerkoflerstraße
Innsbruck, 6020

from

Innsbruck,