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Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00853632
Recruitment Status : Active, not recruiting
First Posted : March 2, 2009
Last Update Posted : September 5, 2021
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Mitral Valve Regurgitation Mitral Valve Incompetence Heart Failure Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES Not Applicable

Detailed Description:

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 will be collected from each subject preoperatively, at 6 months and annually post implant through 8 year follow-ups. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2007
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Mitral valve replacement
Other Name: Magna Mitral 7000/7000TFX, Magna Mitral Ease 7200TFX, 7300/7300TFX

Primary Outcome Measures :
  1. Primary Safety Endpoints [ Time Frame: Long term safety performance ]

    Long term safety performance will be evaluated by comparing the linearized rates listed below to the objective performance criteria referenced in ISO 5840- 2005, Cardiovascular Implants-Cardiac Valve Prostheses.

    • Thromboembolism
    • All Hemorrhage
    • All Perivalvular Leak
    • Endocarditis

  2. Primary Effectiveness Endpoints [ Time Frame: 8 years post-implant ]
    The primary effectiveness endpoint will be the percentage of subjects in NYHA functional classification I or II at 8 years post-implant.

Secondary Outcome Measures :
  1. Secondary Safety Endpoints [ Time Frame: Long term safety performance ]

    Early & late linearized & actuarial analysis of:

    • Thromboembolism
    • Valve thrombosis
    • All hemorrhage
    • Major hemorrhage
    • All perivalvular leak
    • Major perivalvular leak
    • Endocarditis
    • Hemolysis
    • Structural valve deterioration
    • Non-structural valve dysfunction
    • Reoperation
    • Explant
    • Death
    • Valve-related death

  2. Secondary Safety Endpoints [ Time Frame: 6 month, 1 year and annual follow-up visits ]
    Blood studies including white blood count, red blood count, hematocrit, plasma free hemoglobin (or haptoglobin and SLDH), platelet and reticulocyte counts will be used to evaluate the rate of hemolysis and adverse events at the 6 month, 1 year and annual follow-up visits.

  3. Secondary Effectiveness Endpoints [ Time Frame: 8 years post-implant ]

    The secondary Effectiveness endpoints will be: Hemodynamic Performance by echocardiography at 8 years post implant, which includes:

    • Peak Gradient
    • Mean Gradient
    • Effective Orifice Area
    • Effective Orifice Area Index
    • Performance Index
    • Cardiac Output
    • Cardiac Index
    • Severity of Valvular Regurgitation
    • LV Mass Regression

  4. Secondary Effectiveness Endpoints [ Time Frame: 6 months post-implant ]
    Quality of Life Survey (EQ-5D) at 6 month post index procedure as compared to preoperative baseline.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00853632

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United States, California
Dignity Health Research Institute
Sacramento, California, United States, 95816
United States, Florida
AdventHealth Orlando
Orlando, Florida, United States, 32803
United States, Illinois
Northwestern University Hospital
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa Hospital & Clinics
Iowa City, Iowa, United States, 52242
Iowa Heart Medical Center
West Des Moines, Iowa, United States, 50266
United States, Michigan
University of Michigan Medical School
Ann Arbor, Michigan, United States, 48109
Spectrum Health Hospitals
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
United States, New York
North Shore University Hospital, NY
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Krankenhaus Hietzing
Vienna, Austria, A-1130
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Quebec, Canada, G1V4G5
University Clinica Eppendorf
Hamburg, Germany, 20246
Klinikum der Friedrich Schiller University
Jena, Germany, 07740
Sponsors and Collaborators
Edwards Lifesciences
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Study Director: Mary Edwards Edwards Lifesciences
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Responsible Party: Edwards Lifesciences Identifier: NCT00853632    
Other Study ID Numbers: 2006-05
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Keywords provided by Edwards Lifesciences:
Mitral valve
pericardial bioprostheses
bovine pericardial leaflets
mitral valve replacement
mitral valve regurgitation
Heart valve disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases