Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT00853632
First received: February 26, 2009
Last updated: July 1, 2015
Last verified: July 2015
  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
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

Contacts
Contact: Bruce Van Deman 949-250-2626 bruce_van_deman@edwards.com

Locations
United States, California
Mercy Heart and Vascular Institue Recruiting
Sacramento, California, United States, 95819
Contact: Allen Morris    916-733-6850      
Principal Investigator: Allen Morris, MD         
United States, Florida
Florida Hospital Cardiovascular Research Institute Recruiting
Orlando, Florida, United States, 32803
Contact: Kevin Accola, MD    407-425-1566      
Principal Investigator: Kevin Accola, MD         
United States, Illinois
Northwestern University Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Erika Elganzouri, RN, MSN, MBA    312-926-2828    eelganzo@nm.org   
Contact: Andrea Kim    312-695-6826    akim1@nmh.org   
Principal Investigator: S. Chris Malaisrie, MD         
United States, Iowa
University of Iowa Hospital & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Ronda Wilson, RN    319-353-6675    Ronda-k-wilson@uiowa.edu   
Principal Investigator: Sotiris Stamou, MD         
Iowa Heart Medical Center Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Amy Ollinger, RN, BSN    319-353-6675    amy-ollinger@uiowa.edu   
Principal Investigator: Mohammad Bashir, MD         
United States, Michigan
University of Michigan Medical School Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Steven Bolling, MD    734-936-4981      
Principal Investigator: Steven Bolling, MD         
Spectrum Health Hospitals Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Nathan Kaline Quay, BS    616-267-2572    Nathan.Quay@spectrumhealth.org   
Contact: Beth Van Over, RN,BSN    616.391.9360    beth.vanover@spectrumhealth.org   
Principal Investigator: Tomasz A Timek, MD         
United States, Missouri
Missouri Baptist Medical Center Recruiting
St. Louis, Missouri, United States, 63131
Contact: Nicholas T Kouchoukos, MD    314-996-5708      
Principal Investigator: Nicholas T Kouchoukos, MD         
United States, New York
North Shore University Hospital, NY Recruiting
Manhasset, New York, United States, 11030
Contact: Alan Hartman, MD    516-562-4970      
Principal Investigator: Alan Hartman, MD         
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Jacob Scheinerman, MD    718-470-7460      
Principal Investigator: Jacob Scheinerman, MD         
United States, Texas
Scott & White Memorial Hospital Terminated
Temple, Texas, United States, 76508
Austria
Krankenhaus Hietzing Recruiting
Vienna, Austria, A-1130
Contact: Martin Granbenwoeg    +431 80110 2390      
Principal Investigator: Martin Grabenwoeg         
Belgium
Academic Hospital Middelheim Terminated
Antwerpen, Linderreef 1, Belgium, B-2020
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Dr. Jian Ye, MD    604-806-9349    jye@providencehealth.bc.ca   
Contact: Catherine Mok, RN, CRM    604-806-8383    CMok@providencehelth.bc.ca   
Principal Investigator: Dr. Jian Ye, MD         
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec Recruiting
Quebec, Canada, G1V4G5
Contact: Hugo Tremblay    418-656-8711 ext 3797    hugo.tremblay@criucpq.ulaval.ca   
Contact: Isabelle Deneufbourg    418-656-8711    isabelle.deneufbourg@criucpq.ulaval.ca   
Principal Investigator: Francois Dagenais, MD         
Germany
University Clinica Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Hermann Reichenspurner    +49 40 42803 4926      
Principal Investigator: Hermann Reichenspurner         
Klinikum der Friedrich Schiller University Recruiting
Jena, Germany, 07740
Contact: Jan Gummert, MD    +49 3641 93229 01      
Principal Investigator: Professor Doenst         
Switzerland
Unversitats Spital Zurich Recruiting
Zurich, Switzerland, CH-8091
Contact: Michael Stader    + 41 44 255 36 44    Michael.Stader@usz.ch   
Principal Investigator: Diana Reser, MD         
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Study Director: Bruce Van Deman Edwards Lifescience
  More Information

No publications provided

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: July 1, 2015
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:
Coronary Artery Disease
Coronary Disease
Mitral Valve Insufficiency
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 03, 2015