Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

NCT ID: NCT00853632

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 329 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2024-03-06

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.

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.

Conditions

Coronary Artery Disease; Mitral Valve Regurgitation; Mitral Valve Incompetence; Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device - CEP Mitral Valve

Group Type: OTHER

CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES

Intervention Type: DEVICE

Mitral valve replacement

Interventions

CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES

Mitral valve replacement

Intervention Type: DEVICE

Other Intervention Names

Magna Mitral 7000/7000TFX, Magna Mitral Ease 7200TFX, 7300/7300TFX

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dignity Health Research Institute

Sacramento, California, United States

AdventHealth Orlando

Orlando, Florida, United States

Northwestern University Hospital

Chicago, Illinois, United States

University of Iowa Hospital & Clinics

Iowa City, Iowa, United States

Iowa Heart Medical Center

West Des Moines, Iowa, United States

University of Michigan Medical School

Ann Arbor, Michigan, United States

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

North Shore University Hospital, NY

Manhasset, New York, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Krankenhaus Hietzing

Vienna, , Austria

St. Paul's Hospital

Vancouver, British Columbia, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, , Canada

University Clinica Eppendorf

Hamburg, , Germany

Klinikum der Friedrich Schiller University

Jena, , Germany

Countries

United States; Austria; Canada; Germany

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2006-05

Identifier Type: -

Identifier Source: org_study_id