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

Edwards Lifesciences

Status: Completed

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

Treatments: Device: Implantation of CEP Magna Ease Model 3300TFX

Study type: Interventional

Funder types: Industry

Identifiers

NCT01171625

2007-08

Details and patient eligibility

About

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.

Full description

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 at discharge, 6 months, one year, and annually for a minimum of 8 years.

Enrollment: 283 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient requires, as indicated in the preoperative evaluation, a replacement aortic valve.
2. The patient is an average or better operative risk.
3. The patient is geographically stable and agrees to attend follow-up assessments at the hospital of surgical services for at least 8 years.
4. The patient is 18 years or older.
5. The patient has signed and dated the subject informed consent form prior to surgery.

Exclusion criteria

1. The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
2. The patient presents with active endocarditis within the last 3 months.
3. The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism).
4. The patient has an aneurismal aortic degenerative condition (e.g., cystic medial necrosis, Marfan's syndrome).
5. The patient is pregnant or lactating.
6. The patient is an intravenous drug abuser.
7. The patient is currently a prison inmate.
8. The patient is currently participating in a study of an investigational drug or device.
9. The patient requires replacement of a native or prosthetic mitral, tricuspid or pulmonic valve.
10. The patient requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device.
11. The patient was previously enrolled in the study.
12. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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283 participants in 1 patient group

CEP Aortic Bioprothesis, model 3300TFX

Other group

Treatment:

Device: Implantation of CEP Magna Ease Model 3300TFX