Magna Mitral - 23mm

Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:13 - Any
Start Date:March 2011
End Date:November 2018

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Clinical Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX

The purpose of this clinical study is to obtain human clinical data that demonstrates that
the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is
a safe and effective replacement heart valve.

This is a prospective, non-randomized, multi-site, descriptive study. A minimum of 15 and up
to 20 subjects will be implanted at a minimum of 2 and up to 8 participating investigational
sites within the US and internationally.

Inclusion Criteria:

1. Patient has mitral valve disease requiring surgical replacement

2. Patient has provided written informed consent prior to mitral valve surgery

3. Patient is expected to survive surgery and be discharged

4. Patient is willing to comply with specified follow-up evaluations

5. Patient is 13 years of age or older

Exclusion Criteria:

1. Patient has life expectancy < 12 months due to non-cardiac co-morbid conditions;

2. Patient has/had active endocarditis within the last 3 months

3. Patient requires replacement of a native or previously implanted prosthetic,
tricuspid, pulmonic or aortic valve;

4. Patient was previously enrolled and implanted in the study

5. Patient has/had prior aortic, tricuspid and/ or pulmonary valve surgery, which
included implantation of a bioprosthetic valve or mechanical valve that will remain in

6. Patient has a body surface area (BSA) > 1.9m2

7. Female patients who are pregnant, planning to become pregnant, or lactating

8. Patient has a documented history of substance ( drug or alcohol) abuse

9. Patient is currently a prison inmate

10. Patient is currently participating in an investigational drug or another device study

11. Patient is undergoing renal dialysis for chronic renal failure or has

12. Patient has active myocarditis

13. Patient has had an acute preoperative neurological deficit, myocardial infarction, or
cardiac event and has not returned to baseline or stabilized > 30 days prior to the
planned v alve implant surgery

14. Patient has an abnormality such as an aortic aneurysm (e.g. due to cystic medial
necrosis or Marfan's syndrome), aortic dissection, or ventricular aneurysm that might
We found this trial at
1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Michael Rosenbloom, MD
Phone: 856-757-9783
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
Camden, NJ
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Chicago, Illinois 60611
Principal Investigator: Chris Malaisrie, MD
Phone: 312-926-2828
Chicago, IL
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200 Hawkins Dr,
Iowa City, Iowa 52242
Principal Investigator: Mohammad Bashir, MD
Phone: 319-353-6675
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
Iowa City, IA
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Nashville, Tennessee 37205
Principal Investigator: Evelio Rodriguez, MD
Phone: 615-222-4356
Nashville, TN
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Kevin Accola, MD
Phone: 407-303-5600
Florida Hospital Florida Hospital is one of the country
Orlando, FL
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Saint Louis, Missouri 63110
Saint Louis, MO
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