Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT00853632
First received: February 26, 2009
Last updated: February 1, 2016
Last verified: February 2016
  Purpose
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 Intervention
Coronary Artery Disease
Mitral Valve Regurgitation
Mitral Valve Incompetence
Heart Failure
Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Long term safety performance will be evaluated by comparing the linearized yearly rates listed below to the objective performance criteria referenced in the 1994 FDA's Heart Valve Guidance: • Thromboembolism • All Hemorrhage [ Time Frame: Long term safety performance ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety: Early & late linearized & actuarial analysis of: TE,Valve thrombosis, All hemorrhage & PV leak Endocarditis Hemolysis SVD NSVD Reop Explant Death Blood Data Effectiveness:Echo Hemodynamic Performance 8 yrs post implant QOL Survey EQ-5D [ Time Frame: Long term safety performance ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: August 2007
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Device - CEP Mitral Valve Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
Mitral valve replacement
Other Name: Magna Mitral 7000/7000TFX, Magna Mitral Ease 7200TFX, 7300/7300TFX

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853632

Locations
United States, California
Mercy Heart and Vascular Institue
Sacramento, California, United States, 95819
United States, Florida
Florida Hospital Cardiovascular Research Institute
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
St. 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
United States, Texas
Scott & White Memorial Hospital
Temple, Texas, United States, 76508
Austria
Krankenhaus Hietzing
Vienna, Austria, A-1130
Belgium
Academic Hospital Middelheim
Antwerpen, Linderreef 1, Belgium, B-2020
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Quebec, Canada, G1V4G5
Germany
University Clinica Eppendorf
Hamburg, Germany, 20246
Klinikum der Friedrich Schiller University
Jena, Germany, 07740
Switzerland
Unversitats Spital Zurich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Study Director: Bruce Van Deman Edwards Lifescience
  More Information

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT00853632     History of Changes
Other Study ID Numbers: Study# 2006-05 
Study First Received: February 26, 2009
Last Updated: February 1, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Edwards Lifesciences:
Mitral valve
pericardial bioprostheses
PERIMOUNT
bovine pericardial leaflets
mitral valve replacement
mitral valve regurgitation
Heart valve disease

Additional relevant MeSH terms:
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on August 23, 2016