Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

Not Applicable

Completed

Conditions: Mitral Valve Regurgitation
Coronary Artery Disease
Mitral Valve Incompetence
Heart Failure

Interventions: Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES

Registration Number: NCT00853632

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 329

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device - CEP Mitral Valve	CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES	-

Primary Outcome Measures

Name	Time	Method
Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort	Events occurring ≥ 31 days and up through 8 years post-implant	A linearized rate percentage is calculated by the following equation: \[(Total number of late adverse events in each category/total number of late patient years) x 100\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
Primary Effectiveness Endpoints	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

Name	Time	Method
Percent of Early Adverse Events	Events occurring within 30 days of procedure	Total number of early adverse events, in each category, occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
Subject's Average Platelet Count Over Time	6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits	This is laboratory analysis of Platelet count on blood drawn from subjects. The purpose of platelets is to create hemostasis, which is the prevention of hemorrhaging (bleeding) and the process of keeping blood inside the vessel walls. A normal platelet range is 150 to 450 10\^3 cells/microliter. In general, results either lower or higher than the normal range can indicate something is wrong.
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time	6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits	The serum lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues. Normal levels of LDH in the blood can vary depending on the lab but usually range between 140 units per liter (U/L) to 280 U/L for adults and tend to be higher for children and teens. In general, results either lower or higher than the normal range can indicate something is wrong.
Subject's Average Plasma Free Hemoglobin Over Time	6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits	Laboratory analysis of Plasma Free Hemoglobin (Pf Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong.
Subject's Average Cardiac Index Measurement	Baseline and 8 years post-implant	Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m\^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient.
Subject's Average Left Ventricular Mass Regression	Baseline and 8 years post-implant	Patients can experience an enlargement of the left ventricle (chamber) of their heart because it works harder with a defective heart valve. Left ventricular mass regression evaluates if the patient experiences a decrease in the size of the left ventricle (chamber) after the repair or replacement of their heart valve.
Subject's Average Red Blood Cell Count	6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits	The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10\^6 cells/microliters and for men is 4.7 to 6.1 10\^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range may indicate something is wrong.
Subject's Average White Blood Cell Count	6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits	Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10.0 10\^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.
Subject's Average Hemoglobin Count	6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits	This is the laboratory analysis of Hemoglobin count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong.
Subject's Average Hematocrit Count	6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits	This is laboratory analysis of Hematocrit percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong.
Subject's Average Reticulocytes Percentage Over Time	6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits	Laboratory Analysis of reticulocytes on blood drawn from subjects. Reticulocytes are newly produced immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood. The reference range for reticulocytes is 0.5 - 2.6 % of red blood cells. In general, results either lower or higher than the normal range can indicate something is wrong.
Subject's Average Mean Gradient Measurement	Baseline and 8 years post-implant	Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time	6 months post-implant	The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from a minimum of 0 and a maximum of 100. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort	Events occurring ≥ 31 days and up through 8 years post-implant	A linearized rate percentage is calculated by the following equation: \[(Total number of late adverse events in each category/total number of late patient years) x 100\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
Subject's Average Peak Gradient Measurement	Baseline and 8 years post-implant	Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
Subject's Average Effective Orifice Area (EOA) Measurement	Baseline and 8 years post-implant	Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.
Subject's Average Effective Orifice Area Index (EOAI) Measurement	Baseline and 8 years post-implant	Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
Subject's Average Cardiac Output Measurement	Baseline and 8 years post-implant	Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse.
Subject's Average Haptoglobin Over Time	6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits	Haptoglobin is a protein produced by your liver. It binds with hemoglobin, which is a protein found in red blood cells. When red blood cells are destroyed, they release hemoglobin. The released hemoglobin is called "free hemoglobin." Haptoglobin attaches to the free hemoglobin to create a haptoglobin-hemoglobin complex. This complex travels to the liver, where it's removed from the body. A normal haptoglobin level falls between 45 and 200 milligrams of haptoglobin per deciliter of blood. In general, results either lower or higher than the normal range can indicate something is wrong.

Trial Locations

Locations (15): North Shore University Hospital, NY
🇺🇸
Manhasset, New York, United States
Krankenhaus Hietzing
🇦🇹
Vienna, Austria
Iowa Heart Medical Center
🇺🇸
West Des Moines, Iowa, United States
University of Iowa Hospital & Clinics
🇺🇸
Iowa City, Iowa, United States
Northwestern University Hospital
🇺🇸
Chicago, Illinois, United States
Spectrum Health Hospitals
🇺🇸
Grand Rapids, Michigan, United States
Missouri Baptist Medical Center
🇺🇸
Saint Louis, Missouri, United States
Long Island Jewish Medical Center
🇺🇸
New Hyde Park, New York, United States
St. Paul's Hospital
🇨🇦
Vancouver, British Columbia, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
🇨🇦
Quebec, Canada
University Clinica Eppendorf
🇩🇪
Hamburg, Germany
Klinikum der Friedrich Schiller University
🇩🇪
Jena, Germany
Dignity Health Research Institute
🇺🇸
Sacramento, California, United States
AdventHealth Orlando
🇺🇸
Orlando, Florida, United States
University of Michigan Medical School
🇺🇸
Ann Arbor, Michigan, United States