Status:
COMPLETED
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
Lead Sponsor:
Edwards Lifesciences
Conditions:
Coronary Artery Disease
Aortic Valve Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed 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 valv...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT01171625
Start Date
October 1 2007
End Date
September 1 2018
Last Update
April 17 2020
Active Locations (13)
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1
Mercy General Hospital
Sacramento, California, United States, 95819
2
Cooper University Hospital
Camden, New Jersey, United States, 08103
3
Morristown Memorial Hospital
Morristown, New Jersey, United States, 09762
4
Providence Heart & Vascular Institute
Portland, Oregon, United States, 97225