Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:7/29/2018
Start Date:August 2007
End Date:December 2022

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Carpentier-Edwards® Perimount Magna® Mitral Pericardial Bioprostheses Models 7000/7000 TFX and Carpentier-Edwards® Perimount Magna® Mitral Ease™ Pericardial Bioprostheses Models 7200TFX and 7300/7300TFX

The purpose of the study is to demonstrate the long term safety and effectiveness of the
Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve
replacement with or without concomitant procedures requiring cardiopulmonary bypass.

This is a prospective, single-arm, multi-center study to be conducted in the US and outside
the US (OUS). Approximately 250 subjects are planned to be enrolled to obtain long term data
from 101 subjects at 8 years post implant of the Magna mitral valve. Of these 250,
approximately 38 (15%) are anticipated to be simultaneous aortic and mitral replacements.
Subject enrollment will not start in the US before obtaining FDA approval of this post market
study.

Assessments will be obtained for the preoperative and operative visits, and postoperatively
at discharge, six months, 1-year and annually thereafter for a minimum of 8 years. Subject's
demographics (date of birth, sex), physical assessment (heart rate, height, weight, systolic
and diastolic blood pressures), New York Heart Association (NYHA) functional class, cardiac
rhythm, cardiovascular medical history/risk factors, non-cardiovascular conditions, previous
cardiovascular procedures/interventions, antithromboembolic and lipid lowering medications
and coagulation profile. Blood data is required for each subject preoperatively and at 6
months. Echocardiographic evaluation required for each subject preoperatively, at discharge,
6 months (between 3-6 months), 1, 2, 4, 6, and 8 year follow-ups. A QOL survey (EQ-5D) will
be completed by the subject pre-operatively and at the 6-month follow-up visit.

Inclusion Criteria:

- The patient requires, as indicated in the preoperative evaluation, a replacement
mitral valve.

- The patient has signed and dated the subject informed consent form prior to surgery.

- The patient is expected to survive the surgery and be discharged.

- The patient is geographically stable and agrees to attend follow-up assessments.

- The patient is 18 years or older.

Exclusion Criteria:

- 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 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 tricuspid or pulmonic
valve.

- The patient requires replacement of a native or prosthetic aortic valve with a
prosthesis other than a commercially available Carpentier-Edwards PERIMOUNT Valve
(i.e. models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 3300TFX)*.

- The patient was previously enrolled in the study.

- The 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
situ.
We found this trial at
12
sites
Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Chicago, Illinois 60611
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Chicago, IL
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Grand Rapids, Michigan 49503
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Grand Rapids, MI
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Iowa City, IA
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Manhasset, New York 11030
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Manhasset, NY
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270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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New Hyde Park, NY
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Orlando, FL
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Sacramento, California 95819
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Sacramento, CA
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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Saint Louis, MO
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2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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Temple, TX
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Vienna, 1130
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Vienna,
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West Des Moines, Iowa 50266
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West Des Moines, IA
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