Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
This study is currently recruiting participants.
Verified March 2013 by Edwards Lifesciences
Sponsor:
Edwards Lifesciences
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT00853632
First received: February 26, 2009
Last updated: March 13, 2013
Last verified: March 2013
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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 |
Resource links provided by NLM:
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 2014 (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
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853632
Contacts
| Contact: Carol Renner, RN, BSN | 949-250-2389 | carol_renner@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 Feinberg School of Medicine | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Patrick McCarthy, MD 312-695-3114 | |
| Principal Investigator: Patrick McCarthy, MD | |
| United States, Iowa | |
| Iowa Heart Medical Center | Recruiting |
| West Des Moines, Iowa, United States, 50266 | |
| Contact: David Hockmuth, MD 515-235-5000 | |
| Principal Investigator: David Hockmuth, 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: Robert Hooker, MD 616-391-2904 | |
| Principal Investigator: Robert Hooker, 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 | Recruiting |
| Temple, Texas, United States, 76508 | |
| Contact: Kenton Zehr, MD 254-724-4910 | |
| Principal Investigator: Kenton Zehr, M.D., MD | |
| Austria | |
| Krankenhaus Hietzing | Recruiting |
| Vienna, Austria, A-1130 | |
| Contact: Martin Granbenwoeg +431 80110 2390 | |
| Principal Investigator: Martin Grabenwoeg | |
| Belgium | |
| Academic Hospital Middelheim | Recruiting |
| Antwerpen, Linderreef 1, Belgium, B-2020 | |
| Contact: Phillip Van Cauwelaert +32 3 280 3882 Phillip.VanCauwelaert@zna.be | |
| Principal Investigator: Phillip Van Cauwelaert | |
| 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 | |
| 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: Michele Genoni, MD +41 44 255 32 98 | |
| Principal Investigator: Volkman Falk, MD | |
Sponsors and Collaborators
Edwards Lifesciences
Investigators
| Study Director: | Carol Renner, BSN | 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: | March 13, 2013 |
| 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 Myocardial Ischemia Coronary Disease Heart Failure Mitral Valve Insufficiency Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Heart Valve Diseases |
ClinicalTrials.gov processed this record on June 17, 2013