Coronary Artery Disease, Heart Failure, Mitral Valve Incompetence, Mitral Valve Regurgitation
Conditions
Keywords
Mitral valve, pericardial bioprostheses, PERIMOUNT, bovine pericardial leaflets, mitral valve replacement, mitral valve regurgitation, Heart valve disease
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.
Interventions
DEVICECEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
Mitral valve replacement
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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 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 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 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. |
| 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 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. |
Countries
Austria, Canada, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device - CEP Mitral Valve Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve | 329 |
| Total | 329 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 88 |
| Overall Study | Exit with other reason | 22 |
| Overall Study | Lost to Follow-up | 30 |
| Overall Study | Reoperation/Explant | 17 |
| Overall Study | Withdrawal by Subject | 45 |
Baseline characteristics
| Characteristic | Device - CEP Mitral Valve | — |
|---|---|---|
| Age, Continuous | 69.7 Years STANDARD_DEVIATION 10.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 55 participants | — |
| Region of Enrollment Europe | 105 participants | — |
| Region of Enrollment United States | 169 participants | — |
| Sex: Female, Male Female | 201 Participants | — |
| Sex: Female, Male Male | 128 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 88 / 329 |
| other Total, other adverse events | 206 / 329 |
| serious Total, serious adverse events | 281 / 329 |
Outcome results
Primary
Primary Effectiveness Endpoints
The primary effectiveness endpoint will be the percentage of subjects in NYHA functional classification I or II at 8 years post-implant.
Time frame: 8 years post-implant
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device - CEP Mitral Valve | Primary Effectiveness Endpoints | 93 Participants |
Primary
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
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.
Time frame: Events occurring ≥ 31 days and up through 8 years post-implant
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device - CEP Mitral Valve | 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 | Thromboembolism | 2.0 Linearized rate percentage |
| Device - CEP Mitral Valve | 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 | All bleeding events | 5.8 Linearized rate percentage |
| Device - CEP Mitral Valve | 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 | All paravalvular leak | 0.3 Linearized rate percentage |
| Device - CEP Mitral Valve | 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 | Endocarditis | 0.3 Linearized rate percentage |
Secondary
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort
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.
Time frame: Events occurring ≥ 31 days and up through 8 years post-implant
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device - CEP Mitral Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort | All Bleeding Events | 5.8 Linearized rate percentage |
| Device - CEP Mitral Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort | Structural Valve Deterioration | 1.8 Linearized rate percentage |
| Device - CEP Mitral Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort | Reoperation | 0.2 Linearized rate percentage |
| Device - CEP Mitral Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort | Thromboembolism | 2.0 Linearized rate percentage |
| Device - CEP Mitral Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort | Valve Thrombosis | 0.1 Linearized rate percentage |
| Device - CEP Mitral Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort | Major bleeding | 3.2 Linearized rate percentage |
| Device - CEP Mitral Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort | Endocarditis | 0.3 Linearized rate percentage |
| Device - CEP Mitral Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort | Hemolysis | 0.0 Linearized rate percentage |
| Device - CEP Mitral Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort | Non-Structural Valve Dysfunction | 0.4 Linearized rate percentage |
| Device - CEP Mitral Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort | Explant | 1.1 Linearized rate percentage |
| Device - CEP Mitral Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort | Death | 5.3 Linearized rate percentage |
Secondary
Percent of Early Adverse Events
Total number of early adverse events, in each category, occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
Time frame: Events occurring within 30 days of procedure
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device - CEP Mitral Valve | Percent of Early Adverse Events | Thromboembolism | 2.1 percentage |
| Device - CEP Mitral Valve | Percent of Early Adverse Events | Valve Thrombosis | 0.0 percentage |
| Device - CEP Mitral Valve | Percent of Early Adverse Events | All Bleeding Events | 12.2 percentage |
| Device - CEP Mitral Valve | Percent of Early Adverse Events | Major bleeding | 9.4 percentage |
| Device - CEP Mitral Valve | Percent of Early Adverse Events | Endocarditis | 0.0 percentage |
| Device - CEP Mitral Valve | Percent of Early Adverse Events | Hemolysis | 0.0 percentage |
| Device - CEP Mitral Valve | Percent of Early Adverse Events | Structural Valve Deterioration | 0.0 percentage |
| Device - CEP Mitral Valve | Percent of Early Adverse Events | Non-Structural Valve Dysfunction | 1.5 percentage |
| Device - CEP Mitral Valve | Percent of Early Adverse Events | Reoperation | 0.9 percentage |
| Device - CEP Mitral Valve | Percent of Early Adverse Events | Explant | 0.9 percentage |
| Device - CEP Mitral Valve | Percent of Early Adverse Events | Death | 2.7 percentage |
Secondary
Subject's Average Cardiac Index Measurement
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.
Time frame: Baseline and 8 years post-implant
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Cardiac Index Measurement | Baseline | 2.50 L/min/m^2 | Standard Deviation 0.86 |
| Device - CEP Mitral Valve | Subject's Average Cardiac Index Measurement | 8 years | 3.32 L/min/m^2 | Standard Deviation 0.91 |
Secondary
Subject's Average Cardiac Output Measurement
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.
Time frame: Baseline and 8 years post-implant
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Cardiac Output Measurement | Baseline | 4.70 L/min | Standard Deviation 1.67 |
| Device - CEP Mitral Valve | Subject's Average Cardiac Output Measurement | 8 years | 6.02 L/min | Standard Deviation 1.52 |
Secondary
Subject's Average Effective Orifice Area (EOA) Measurement
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.
Time frame: Baseline and 8 years post-implant
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Effective Orifice Area (EOA) Measurement | Baseline | 1.39 cm^2 | Standard Deviation 0.93 |
| Device - CEP Mitral Valve | Subject's Average Effective Orifice Area (EOA) Measurement | 8 years | 1.90 cm^2 | Standard Deviation 0.67 |
Secondary
Subject's Average Effective Orifice Area Index (EOAI) Measurement
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.
Time frame: Baseline and 8 years post-implant
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Effective Orifice Area Index (EOAI) Measurement | Baseline | 0.73 cm^2/m^2 | Standard Deviation 0.48 |
| Device - CEP Mitral Valve | Subject's Average Effective Orifice Area Index (EOAI) Measurement | 8 years | 1.03 cm^2/m^2 | Standard Deviation 0.38 |
Secondary
Subject's Average Haptoglobin Over Time
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.
Time frame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. The protocol allowed subjects to have the option of having (haptoglobin and SLDH tests) or alternatively a plasma free hemoglobin test at each timeframe. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Haptoglobin Over Time | 4 years | 111.4 mg/dL | Standard Deviation 54.9 |
| Device - CEP Mitral Valve | Subject's Average Haptoglobin Over Time | 2 years | 110.1 mg/dL | Standard Deviation 38.9 |
| Device - CEP Mitral Valve | Subject's Average Haptoglobin Over Time | 5 years | 79.0 mg/dL | Standard Deviation 49.1 |
| Device - CEP Mitral Valve | Subject's Average Haptoglobin Over Time | 1 year | 110.0 mg/dL | Standard Deviation 52 |
| Device - CEP Mitral Valve | Subject's Average Haptoglobin Over Time | 6 years | 118.7 mg/dL | Standard Deviation 95.5 |
| Device - CEP Mitral Valve | Subject's Average Haptoglobin Over Time | 6 months | 118.7 mg/dL | Standard Deviation 59 |
| Device - CEP Mitral Valve | Subject's Average Haptoglobin Over Time | 3 years | 103.6 mg/dL | Standard Deviation 46.6 |
| Device - CEP Mitral Valve | Subject's Average Haptoglobin Over Time | 8 years | 115.0 mg/dL | — |
| Device - CEP Mitral Valve - 27mm | Subject's Average Haptoglobin Over Time | 8 years | 129.0 mg/dL | Standard Deviation 23.3 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Haptoglobin Over Time | 3 years | 139.2 mg/dL | Standard Deviation 80.3 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Haptoglobin Over Time | 5 years | 152.4 mg/dL | Standard Deviation 81.5 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Haptoglobin Over Time | 4 years | 139.9 mg/dL | Standard Deviation 77.9 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Haptoglobin Over Time | 1 year | 120.8 mg/dL | Standard Deviation 68.9 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Haptoglobin Over Time | 6 months | 143.9 mg/dL | Standard Deviation 90.8 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Haptoglobin Over Time | 7 years | 85.2 mg/dL | Standard Deviation 78 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Haptoglobin Over Time | 6 years | 109.8 mg/dL | Standard Deviation 71.4 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Haptoglobin Over Time | 2 years | 127.1 mg/dL | Standard Deviation 76.2 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Haptoglobin Over Time | 5 years | 111.6 mg/dL | Standard Deviation 56.3 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Haptoglobin Over Time | 6 months | 118.0 mg/dL | Standard Deviation 63.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Haptoglobin Over Time | 1 year | 107.9 mg/dL | Standard Deviation 67 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Haptoglobin Over Time | 2 years | 124.2 mg/dL | Standard Deviation 57.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Haptoglobin Over Time | 3 years | 96.2 mg/dL | Standard Deviation 52.5 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Haptoglobin Over Time | 4 years | 97.6 mg/dL | Standard Deviation 49.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Haptoglobin Over Time | 6 years | 103.6 mg/dL | Standard Deviation 58.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Haptoglobin Over Time | 7 years | 107.2 mg/dL | Standard Deviation 72.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Haptoglobin Over Time | 8 years | 106.4 mg/dL | Standard Deviation 40 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Haptoglobin Over Time | 3 years | 117.0 mg/dL | Standard Deviation 36.1 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Haptoglobin Over Time | 5 years | 80.2 mg/dL | Standard Deviation 91.6 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Haptoglobin Over Time | 2 years | 101.8 mg/dL | Standard Deviation 48.3 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Haptoglobin Over Time | 6 years | 126.8 mg/dL | Standard Deviation 37.9 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Haptoglobin Over Time | 1 year | 128.3 mg/dL | Standard Deviation 60.5 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Haptoglobin Over Time | 8 years | 96.0 mg/dL | Standard Deviation 22.6 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Haptoglobin Over Time | 7 years | 51.7 mg/dL | Standard Deviation 40.2 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Haptoglobin Over Time | 6 months | 119.2 mg/dL | Standard Deviation 65.5 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Haptoglobin Over Time | 4 years | 96.9 mg/dL | Standard Deviation 53.5 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Haptoglobin Over Time | 6 months | 70.9 mg/dL | Standard Deviation 68.4 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Haptoglobin Over Time | 2 years | 109.8 mg/dL | Standard Deviation 89.4 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Haptoglobin Over Time | 4 years | 81.1 mg/dL | Standard Deviation 113 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Haptoglobin Over Time | 5 years | 120.1 mg/dL | Standard Deviation 168.1 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Haptoglobin Over Time | 3 years | 109.0 mg/dL | Standard Deviation 19.8 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Haptoglobin Over Time | 1 year | 123.7 mg/dL | Standard Deviation 62.1 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Haptoglobin Over Time | 8 years | 117.0 mg/dL | — |
| Device - CEP Mitral Valve - 33mm | Subject's Average Haptoglobin Over Time | 7 years | 239.0 mg/dL | — |
| Device - CEP Mitral Valve - 33mm | Subject's Average Haptoglobin Over Time | 6 years | 151.0 mg/dL | Standard Deviation 70.7 |
Secondary
Subject's Average Hematocrit Count
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.
Time frame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Hematocrit Count | 8 years | 38.6 Percentage of red blood cells | Standard Deviation 5.5 |
| Device - CEP Mitral Valve | Subject's Average Hematocrit Count | 4 years | 39.0 Percentage of red blood cells | Standard Deviation 4.7 |
| Device - CEP Mitral Valve | Subject's Average Hematocrit Count | 1 year | 39.4 Percentage of red blood cells | Standard Deviation 4 |
| Device - CEP Mitral Valve | Subject's Average Hematocrit Count | 5 years | 40.0 Percentage of red blood cells | Standard Deviation 4.5 |
| Device - CEP Mitral Valve | Subject's Average Hematocrit Count | 7 years | 39.8 Percentage of red blood cells | Standard Deviation 4.8 |
| Device - CEP Mitral Valve | Subject's Average Hematocrit Count | 2 years | 39.0 Percentage of red blood cells | Standard Deviation 4.5 |
| Device - CEP Mitral Valve | Subject's Average Hematocrit Count | 6 years | 38.7 Percentage of red blood cells | Standard Deviation 4.8 |
| Device - CEP Mitral Valve | Subject's Average Hematocrit Count | 3 years | 39.4 Percentage of red blood cells | Standard Deviation 4.4 |
| Device - CEP Mitral Valve | Subject's Average Hematocrit Count | 6 months | 38.0 Percentage of red blood cells | Standard Deviation 4.3 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hematocrit Count | 6 years | 39.3 Percentage of red blood cells | Standard Deviation 4.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hematocrit Count | 5 years | 39.7 Percentage of red blood cells | Standard Deviation 4.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hematocrit Count | 3 years | 39.1 Percentage of red blood cells | Standard Deviation 4.3 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hematocrit Count | 4 years | 39.4 Percentage of red blood cells | Standard Deviation 3.9 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hematocrit Count | 2 years | 39.6 Percentage of red blood cells | Standard Deviation 3.7 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hematocrit Count | 8 years | 39.6 Percentage of red blood cells | Standard Deviation 5.1 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hematocrit Count | 1 year | 38.6 Percentage of red blood cells | Standard Deviation 4.3 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hematocrit Count | 6 months | 37.9 Percentage of red blood cells | Standard Deviation 4.3 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hematocrit Count | 7 years | 37.3 Percentage of red blood cells | Standard Deviation 8.2 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hematocrit Count | 5 years | 39.8 Percentage of red blood cells | Standard Deviation 4.7 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hematocrit Count | 6 months | 38.7 Percentage of red blood cells | Standard Deviation 3.8 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hematocrit Count | 1 year | 39.7 Percentage of red blood cells | Standard Deviation 4.1 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hematocrit Count | 2 years | 40.0 Percentage of red blood cells | Standard Deviation 4.7 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hematocrit Count | 3 years | 39.5 Percentage of red blood cells | Standard Deviation 3.8 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hematocrit Count | 4 years | 39.2 Percentage of red blood cells | Standard Deviation 4.3 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hematocrit Count | 6 years | 38.8 Percentage of red blood cells | Standard Deviation 4 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hematocrit Count | 7 years | 38.1 Percentage of red blood cells | Standard Deviation 5.1 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hematocrit Count | 8 years | 39.8 Percentage of red blood cells | Standard Deviation 4.2 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hematocrit Count | 3 years | 39.4 Percentage of red blood cells | Standard Deviation 5.2 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hematocrit Count | 5 years | 39.4 Percentage of red blood cells | Standard Deviation 6.5 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hematocrit Count | 2 years | 39.9 Percentage of red blood cells | Standard Deviation 5.1 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hematocrit Count | 6 years | 40.3 Percentage of red blood cells | Standard Deviation 5.9 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hematocrit Count | 1 year | 38.6 Percentage of red blood cells | Standard Deviation 4.8 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hematocrit Count | 8 years | 38.5 Percentage of red blood cells | Standard Deviation 7.4 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hematocrit Count | 7 years | 38.1 Percentage of red blood cells | Standard Deviation 6.1 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hematocrit Count | 6 months | 38.6 Percentage of red blood cells | Standard Deviation 4.8 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hematocrit Count | 4 years | 40.9 Percentage of red blood cells | Standard Deviation 4.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hematocrit Count | 6 months | 40.7 Percentage of red blood cells | Standard Deviation 5.9 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hematocrit Count | 3 years | 41.7 Percentage of red blood cells | Standard Deviation 5 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hematocrit Count | 5 years | 41.0 Percentage of red blood cells | Standard Deviation 3.7 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hematocrit Count | 2 years | 41.6 Percentage of red blood cells | Standard Deviation 3.1 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hematocrit Count | 4 years | 42.4 Percentage of red blood cells | Standard Deviation 1.2 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hematocrit Count | 8 years | 40.9 Percentage of red blood cells | Standard Deviation 5.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hematocrit Count | 7 years | 42.4 Percentage of red blood cells | Standard Deviation 4.4 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hematocrit Count | 6 years | 42.3 Percentage of red blood cells | Standard Deviation 3.1 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hematocrit Count | 1 year | 41.6 Percentage of red blood cells | Standard Deviation 3.6 |
Secondary
Subject's Average Hemoglobin Count
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.
Time frame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Hemoglobin Count | 8 years | 12.5 g/dL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve | Subject's Average Hemoglobin Count | 4 years | 12.6 g/dL | Standard Deviation 1.5 |
| Device - CEP Mitral Valve | Subject's Average Hemoglobin Count | 1 year | 12.9 g/dL | Standard Deviation 1.5 |
| Device - CEP Mitral Valve | Subject's Average Hemoglobin Count | 5 years | 13.1 g/dL | Standard Deviation 1.4 |
| Device - CEP Mitral Valve | Subject's Average Hemoglobin Count | 7 years | 12.8 g/dL | Standard Deviation 1.6 |
| Device - CEP Mitral Valve | Subject's Average Hemoglobin Count | 2 years | 12.5 g/dL | Standard Deviation 2.3 |
| Device - CEP Mitral Valve | Subject's Average Hemoglobin Count | 6 years | 12.5 g/dL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve | Subject's Average Hemoglobin Count | 3 years | 12.9 g/dL | Standard Deviation 1.5 |
| Device - CEP Mitral Valve | Subject's Average Hemoglobin Count | 6 months | 12.4 g/dL | Standard Deviation 1.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hemoglobin Count | 6 years | 12.7 g/dL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hemoglobin Count | 5 years | 13.0 g/dL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hemoglobin Count | 3 years | 13.0 g/dL | Standard Deviation 1.5 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hemoglobin Count | 4 years | 13.0 g/dL | Standard Deviation 1.5 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hemoglobin Count | 2 years | 13.2 g/dL | Standard Deviation 1.4 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hemoglobin Count | 8 years | 12.8 g/dL | Standard Deviation 2 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hemoglobin Count | 1 year | 12.8 g/dL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hemoglobin Count | 6 months | 12.5 g/dL | Standard Deviation 1.5 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Hemoglobin Count | 7 years | 12.7 g/dL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hemoglobin Count | 5 years | 13.0 g/dL | Standard Deviation 1.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hemoglobin Count | 6 months | 12.8 g/dL | Standard Deviation 1.3 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hemoglobin Count | 1 year | 13.3 g/dL | Standard Deviation 1.4 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hemoglobin Count | 2 years | 13.3 g/dL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hemoglobin Count | 3 years | 13.1 g/dL | Standard Deviation 1.4 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hemoglobin Count | 4 years | 12.9 g/dL | Standard Deviation 1.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hemoglobin Count | 6 years | 12.7 g/dL | Standard Deviation 1.3 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hemoglobin Count | 7 years | 12.3 g/dL | Standard Deviation 1.8 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Hemoglobin Count | 8 years | 13.1 g/dL | Standard Deviation 1.4 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hemoglobin Count | 3 years | 13.1 g/dL | Standard Deviation 2 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hemoglobin Count | 5 years | 13.0 g/dL | Standard Deviation 2.3 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hemoglobin Count | 2 years | 13.2 g/dL | Standard Deviation 1.9 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hemoglobin Count | 6 years | 13.4 g/dL | Standard Deviation 2 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hemoglobin Count | 1 year | 12.9 g/dL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hemoglobin Count | 8 years | 12.8 g/dL | Standard Deviation 2.7 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hemoglobin Count | 7 years | 12.7 g/dL | Standard Deviation 2.3 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hemoglobin Count | 6 months | 12.8 g/dL | Standard Deviation 1.6 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Hemoglobin Count | 4 years | 13.6 g/dL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hemoglobin Count | 6 months | 13.7 g/dL | Standard Deviation 2.2 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hemoglobin Count | 3 years | 14.0 g/dL | Standard Deviation 1.8 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hemoglobin Count | 5 years | 13.8 g/dL | Standard Deviation 1.4 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hemoglobin Count | 2 years | 14.0 g/dL | Standard Deviation 1.1 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hemoglobin Count | 4 years | 14.2 g/dL | Standard Deviation 0.7 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hemoglobin Count | 8 years | 13.6 g/dL | Standard Deviation 1.8 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hemoglobin Count | 7 years | 14.0 g/dL | Standard Deviation 1.5 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hemoglobin Count | 6 years | 14.4 g/dL | Standard Deviation 1.1 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Hemoglobin Count | 1 year | 13.9 g/dL | Standard Deviation 1.4 |
Secondary
Subject's Average Left Ventricular Mass Regression
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.
Time frame: Baseline and 8 years post-implant
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Left Ventricular Mass Regression | Baseline | 213.21 grams | Standard Deviation 90.5 |
| Device - CEP Mitral Valve | Subject's Average Left Ventricular Mass Regression | 8 years | 163.71 grams | Standard Deviation 54.5 |
Secondary
Subject's Average Mean Gradient Measurement
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.
Time frame: Baseline and 8 years post-implant
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Mean Gradient Measurement | Baseline | 8.03 mmHg | Standard Deviation 5.42 |
| Device - CEP Mitral Valve | Subject's Average Mean Gradient Measurement | 8 years | 5.70 mmHg | Standard Deviation 2.85 |
Secondary
Subject's Average Peak Gradient Measurement
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.
Time frame: Baseline and 8 years post-implant
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Peak Gradient Measurement | Baseline | 18.56 mmHg | Standard Deviation 9.63 |
| Device - CEP Mitral Valve | Subject's Average Peak Gradient Measurement | 8 years | 14.57 mmHg | Standard Deviation 6.62 |
Secondary
Subject's Average Plasma Free Hemoglobin Over Time
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.
Time frame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. The protocol allowed subjects to have the option of having a plasma free hemoglobin test or alternatively a (haptoglobin and SLDH tests) at each timeframe. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Plasma Free Hemoglobin Over Time | 8 years | 14.2 mg/dL | Standard Deviation 12.2 |
| Device - CEP Mitral Valve | Subject's Average Plasma Free Hemoglobin Over Time | 4 years | 26.3 mg/dL | Standard Deviation 35.2 |
| Device - CEP Mitral Valve | Subject's Average Plasma Free Hemoglobin Over Time | 1 year | 16.3 mg/dL | Standard Deviation 17.5 |
| Device - CEP Mitral Valve | Subject's Average Plasma Free Hemoglobin Over Time | 5 years | 13.8 mg/dL | Standard Deviation 17.6 |
| Device - CEP Mitral Valve | Subject's Average Plasma Free Hemoglobin Over Time | 7 years | 20.6 mg/dL | Standard Deviation 32.1 |
| Device - CEP Mitral Valve | Subject's Average Plasma Free Hemoglobin Over Time | 2 years | 15.2 mg/dL | Standard Deviation 19.3 |
| Device - CEP Mitral Valve | Subject's Average Plasma Free Hemoglobin Over Time | 6 years | 14.0 mg/dL | Standard Deviation 15 |
| Device - CEP Mitral Valve | Subject's Average Plasma Free Hemoglobin Over Time | 3 years | 15.8 mg/dL | Standard Deviation 20.1 |
| Device - CEP Mitral Valve | Subject's Average Plasma Free Hemoglobin Over Time | 6 months | 10.7 mg/dL | Standard Deviation 8.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Plasma Free Hemoglobin Over Time | 6 years | 6.6 mg/dL | Standard Deviation 4.1 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Plasma Free Hemoglobin Over Time | 5 years | 7.5 mg/dL | Standard Deviation 5.8 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Plasma Free Hemoglobin Over Time | 3 years | 11.6 mg/dL | Standard Deviation 14.2 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Plasma Free Hemoglobin Over Time | 4 years | 8.4 mg/dL | Standard Deviation 7.5 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Plasma Free Hemoglobin Over Time | 2 years | 14.0 mg/dL | Standard Deviation 18.4 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Plasma Free Hemoglobin Over Time | 8 years | 11.5 mg/dL | Standard Deviation 9.7 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Plasma Free Hemoglobin Over Time | 1 year | 11.7 mg/dL | Standard Deviation 11.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Plasma Free Hemoglobin Over Time | 6 months | 8.3 mg/dL | Standard Deviation 7.2 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Plasma Free Hemoglobin Over Time | 7 years | 12.3 mg/dL | Standard Deviation 24.5 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Plasma Free Hemoglobin Over Time | 5 years | 9.7 mg/dL | Standard Deviation 9.5 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Plasma Free Hemoglobin Over Time | 6 months | 14.4 mg/dL | Standard Deviation 23.4 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Plasma Free Hemoglobin Over Time | 1 year | 11.5 mg/dL | Standard Deviation 13.5 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Plasma Free Hemoglobin Over Time | 2 years | 7.9 mg/dL | Standard Deviation 6.5 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Plasma Free Hemoglobin Over Time | 3 years | 9.0 mg/dL | Standard Deviation 8.7 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Plasma Free Hemoglobin Over Time | 4 years | 13.6 mg/dL | Standard Deviation 29.9 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Plasma Free Hemoglobin Over Time | 6 years | 12.2 mg/dL | Standard Deviation 13.7 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Plasma Free Hemoglobin Over Time | 7 years | 20.7 mg/dL | Standard Deviation 31.5 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Plasma Free Hemoglobin Over Time | 8 years | 12.5 mg/dL | Standard Deviation 11.2 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Plasma Free Hemoglobin Over Time | 3 years | 7.4 mg/dL | Standard Deviation 5.3 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Plasma Free Hemoglobin Over Time | 5 years | 9.6 mg/dL | Standard Deviation 10.9 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Plasma Free Hemoglobin Over Time | 2 years | 17.0 mg/dL | Standard Deviation 14 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Plasma Free Hemoglobin Over Time | 6 years | 12.1 mg/dL | Standard Deviation 11.9 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Plasma Free Hemoglobin Over Time | 1 year | 18.3 mg/dL | Standard Deviation 25.7 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Plasma Free Hemoglobin Over Time | 8 years | 13.7 mg/dL | Standard Deviation 11.8 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Plasma Free Hemoglobin Over Time | 7 years | 8.5 mg/dL | Standard Deviation 5.6 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Plasma Free Hemoglobin Over Time | 6 months | 17.8 mg/dL | Standard Deviation 35.3 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Plasma Free Hemoglobin Over Time | 4 years | 16.2 mg/dL | Standard Deviation 21.8 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Plasma Free Hemoglobin Over Time | 6 months | 20.1 mg/dL | Standard Deviation 19 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Plasma Free Hemoglobin Over Time | 3 years | 15.4 mg/dL | Standard Deviation 8.9 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Plasma Free Hemoglobin Over Time | 5 years | 17.0 mg/dL | Standard Deviation 7.8 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Plasma Free Hemoglobin Over Time | 2 years | 12.3 mg/dL | Standard Deviation 7.6 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Plasma Free Hemoglobin Over Time | 4 years | 10.0 mg/dL | Standard Deviation 3.2 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Plasma Free Hemoglobin Over Time | 8 years | 8.0 mg/dL | Standard Deviation 2.9 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Plasma Free Hemoglobin Over Time | 7 years | 9.0 mg/dL | Standard Deviation 4.8 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Plasma Free Hemoglobin Over Time | 6 years | 29.8 mg/dL | Standard Deviation 40.2 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Plasma Free Hemoglobin Over Time | 1 year | 12.6 mg/dL | Standard Deviation 8 |
Secondary
Subject's Average Platelet Count Over Time
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.
Time frame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Platelet Count Over Time | 8 years | 175.1 10^3 cells/microliter | Standard Deviation 48.4 |
| Device - CEP Mitral Valve | Subject's Average Platelet Count Over Time | 4 years | 207.2 10^3 cells/microliter | Standard Deviation 79.7 |
| Device - CEP Mitral Valve | Subject's Average Platelet Count Over Time | 1 year | 224.3 10^3 cells/microliter | Standard Deviation 64.9 |
| Device - CEP Mitral Valve | Subject's Average Platelet Count Over Time | 5 years | 203.5 10^3 cells/microliter | Standard Deviation 64.5 |
| Device - CEP Mitral Valve | Subject's Average Platelet Count Over Time | 7 years | 203.4 10^3 cells/microliter | Standard Deviation 60.2 |
| Device - CEP Mitral Valve | Subject's Average Platelet Count Over Time | 2 years | 217.1 10^3 cells/microliter | Standard Deviation 66.8 |
| Device - CEP Mitral Valve | Subject's Average Platelet Count Over Time | 6 years | 197.0 10^3 cells/microliter | Standard Deviation 61.3 |
| Device - CEP Mitral Valve | Subject's Average Platelet Count Over Time | 3 years | 208.0 10^3 cells/microliter | Standard Deviation 87.2 |
| Device - CEP Mitral Valve | Subject's Average Platelet Count Over Time | 6 months | 242.2 10^3 cells/microliter | Standard Deviation 85.7 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Platelet Count Over Time | 6 years | 214.3 10^3 cells/microliter | Standard Deviation 90.9 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Platelet Count Over Time | 5 years | 208.1 10^3 cells/microliter | Standard Deviation 74.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Platelet Count Over Time | 3 years | 210.8 10^3 cells/microliter | Standard Deviation 80.2 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Platelet Count Over Time | 4 years | 212.0 10^3 cells/microliter | Standard Deviation 78.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Platelet Count Over Time | 2 years | 208.9 10^3 cells/microliter | Standard Deviation 70.2 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Platelet Count Over Time | 8 years | 225.1 10^3 cells/microliter | Standard Deviation 92.3 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Platelet Count Over Time | 1 year | 214.7 10^3 cells/microliter | Standard Deviation 76.9 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Platelet Count Over Time | 6 months | 218.5 10^3 cells/microliter | Standard Deviation 83.7 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Platelet Count Over Time | 7 years | 219.6 10^3 cells/microliter | Standard Deviation 77.3 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Platelet Count Over Time | 5 years | 207.4 10^3 cells/microliter | Standard Deviation 123.8 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Platelet Count Over Time | 6 months | 211.6 10^3 cells/microliter | Standard Deviation 68.9 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Platelet Count Over Time | 1 year | 201.6 10^3 cells/microliter | Standard Deviation 69.1 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Platelet Count Over Time | 2 years | 208.4 10^3 cells/microliter | Standard Deviation 80.5 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Platelet Count Over Time | 3 years | 200.3 10^3 cells/microliter | Standard Deviation 86.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Platelet Count Over Time | 4 years | 213.8 10^3 cells/microliter | Standard Deviation 108.2 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Platelet Count Over Time | 6 years | 224.0 10^3 cells/microliter | Standard Deviation 197.2 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Platelet Count Over Time | 7 years | 237.2 10^3 cells/microliter | Standard Deviation 197.9 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Platelet Count Over Time | 8 years | 198.8 10^3 cells/microliter | Standard Deviation 53.6 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Platelet Count Over Time | 3 years | 197.4 10^3 cells/microliter | Standard Deviation 45.8 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Platelet Count Over Time | 5 years | 177.7 10^3 cells/microliter | Standard Deviation 37.6 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Platelet Count Over Time | 2 years | 190.6 10^3 cells/microliter | Standard Deviation 35.9 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Platelet Count Over Time | 6 years | 190.4 10^3 cells/microliter | Standard Deviation 35 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Platelet Count Over Time | 1 year | 196.0 10^3 cells/microliter | Standard Deviation 42.1 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Platelet Count Over Time | 8 years | 189.3 10^3 cells/microliter | Standard Deviation 40.5 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Platelet Count Over Time | 7 years | 202.4 10^3 cells/microliter | Standard Deviation 46.7 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Platelet Count Over Time | 6 months | 202.0 10^3 cells/microliter | Standard Deviation 49.2 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Platelet Count Over Time | 4 years | 188.1 10^3 cells/microliter | Standard Deviation 45.6 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Platelet Count Over Time | 6 months | 202.0 10^3 cells/microliter | Standard Deviation 58.4 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Platelet Count Over Time | 3 years | 191.0 10^3 cells/microliter | Standard Deviation 48.9 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Platelet Count Over Time | 5 years | 212.2 10^3 cells/microliter | Standard Deviation 65.7 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Platelet Count Over Time | 2 years | 175.9 10^3 cells/microliter | Standard Deviation 31 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Platelet Count Over Time | 4 years | 190.9 10^3 cells/microliter | Standard Deviation 40.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Platelet Count Over Time | 8 years | 177.8 10^3 cells/microliter | Standard Deviation 27.9 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Platelet Count Over Time | 7 years | 181.5 10^3 cells/microliter | Standard Deviation 37.1 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Platelet Count Over Time | 6 years | 185.3 10^3 cells/microliter | Standard Deviation 27.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Platelet Count Over Time | 1 year | 201.5 10^3 cells/microliter | Standard Deviation 54.2 |
Secondary
Subject's Average Red Blood Cell Count
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.
Time frame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Red Blood Cell Count | 8 years | 4.3 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve | Subject's Average Red Blood Cell Count | 4 years | 4.3 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve | Subject's Average Red Blood Cell Count | 1 year | 4.4 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve | Subject's Average Red Blood Cell Count | 5 years | 4.4 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve | Subject's Average Red Blood Cell Count | 7 years | 4.5 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve | Subject's Average Red Blood Cell Count | 2 years | 4.3 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve | Subject's Average Red Blood Cell Count | 6 years | 4.3 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve | Subject's Average Red Blood Cell Count | 3 years | 4.3 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve | Subject's Average Red Blood Cell Count | 6 months | 4.4 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Red Blood Cell Count | 6 years | 4.4 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Red Blood Cell Count | 5 years | 4.4 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Red Blood Cell Count | 3 years | 4.4 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Red Blood Cell Count | 4 years | 4.4 10^6 cells/uL | Standard Deviation 0.4 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Red Blood Cell Count | 2 years | 4.4 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Red Blood Cell Count | 8 years | 4.4 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Red Blood Cell Count | 1 year | 4.3 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Red Blood Cell Count | 6 months | 4.4 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Red Blood Cell Count | 7 years | 4.3 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Red Blood Cell Count | 5 years | 4.3 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Red Blood Cell Count | 6 months | 4.3 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Red Blood Cell Count | 1 year | 4.4 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Red Blood Cell Count | 2 years | 4.4 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Red Blood Cell Count | 3 years | 4.4 10^6 cells/uL | Standard Deviation 0.7 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Red Blood Cell Count | 4 years | 4.3 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Red Blood Cell Count | 6 years | 4.3 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Red Blood Cell Count | 7 years | 4.2 10^6 cells/uL | Standard Deviation 0.7 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Red Blood Cell Count | 8 years | 4.3 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Red Blood Cell Count | 3 years | 4.3 10^6 cells/uL | Standard Deviation 0.7 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Red Blood Cell Count | 5 years | 4.2 10^6 cells/uL | Standard Deviation 0.8 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Red Blood Cell Count | 2 years | 4.3 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Red Blood Cell Count | 6 years | 4.3 10^6 cells/uL | Standard Deviation 0.8 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Red Blood Cell Count | 1 year | 4.2 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Red Blood Cell Count | 8 years | 4.1 10^6 cells/uL | Standard Deviation 1 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Red Blood Cell Count | 7 years | 4.1 10^6 cells/uL | Standard Deviation 0.8 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Red Blood Cell Count | 6 months | 4.3 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Red Blood Cell Count | 4 years | 4.4 10^6 cells/uL | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Red Blood Cell Count | 6 months | 4.6 10^6 cells/uL | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Red Blood Cell Count | 3 years | 4.6 10^6 cells/uL | Standard Deviation 0.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Red Blood Cell Count | 5 years | 4.5 10^6 cells/uL | Standard Deviation 0.4 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Red Blood Cell Count | 2 years | 4.6 10^6 cells/uL | Standard Deviation 0.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Red Blood Cell Count | 4 years | 4.6 10^6 cells/uL | Standard Deviation 0.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Red Blood Cell Count | 8 years | 4.4 10^6 cells/uL | Standard Deviation 0.4 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Red Blood Cell Count | 7 years | 4.6 10^6 cells/uL | Standard Deviation 0.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Red Blood Cell Count | 6 years | 4.6 10^6 cells/uL | Standard Deviation 0.4 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Red Blood Cell Count | 1 year | 4.6 10^6 cells/uL | Standard Deviation 0.4 |
Secondary
Subject's Average Reticulocytes Percentage Over Time
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.
Time frame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Reticulocytes Percentage Over Time | 8 years | 1.6 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve | Subject's Average Reticulocytes Percentage Over Time | 4 years | 1.4 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve | Subject's Average Reticulocytes Percentage Over Time | 1 year | 1.4 Percentage of reticulocytes | Standard Deviation 0.6 |
| Device - CEP Mitral Valve | Subject's Average Reticulocytes Percentage Over Time | 5 years | 1.4 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve | Subject's Average Reticulocytes Percentage Over Time | 7 years | 1.6 Percentage of reticulocytes | Standard Deviation 0.4 |
| Device - CEP Mitral Valve | Subject's Average Reticulocytes Percentage Over Time | 2 years | 1.5 Percentage of reticulocytes | Standard Deviation 0.6 |
| Device - CEP Mitral Valve | Subject's Average Reticulocytes Percentage Over Time | 6 years | 1.5 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve | Subject's Average Reticulocytes Percentage Over Time | 3 years | 1.5 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve | Subject's Average Reticulocytes Percentage Over Time | 6 months | 1.2 Percentage of reticulocytes | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Reticulocytes Percentage Over Time | 6 years | 1.5 Percentage of reticulocytes | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Reticulocytes Percentage Over Time | 5 years | 2.6 Percentage of reticulocytes | Standard Deviation 6.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Reticulocytes Percentage Over Time | 3 years | 1.5 Percentage of reticulocytes | Standard Deviation 0.7 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Reticulocytes Percentage Over Time | 4 years | 2.8 Percentage of reticulocytes | Standard Deviation 10.3 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Reticulocytes Percentage Over Time | 2 years | 1.4 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Reticulocytes Percentage Over Time | 8 years | 1.5 Percentage of reticulocytes | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Reticulocytes Percentage Over Time | 1 year | 1.4 Percentage of reticulocytes | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Reticulocytes Percentage Over Time | 6 months | 1.4 Percentage of reticulocytes | Standard Deviation 0.7 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Reticulocytes Percentage Over Time | 7 years | 2.0 Percentage of reticulocytes | Standard Deviation 2.8 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Reticulocytes Percentage Over Time | 5 years | 1.5 Percentage of reticulocytes | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Reticulocytes Percentage Over Time | 6 months | 1.4 Percentage of reticulocytes | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Reticulocytes Percentage Over Time | 1 year | 1.3 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Reticulocytes Percentage Over Time | 2 years | 1.4 Percentage of reticulocytes | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Reticulocytes Percentage Over Time | 3 years | 1.4 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Reticulocytes Percentage Over Time | 4 years | 1.6 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Reticulocytes Percentage Over Time | 6 years | 1.4 Percentage of reticulocytes | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Reticulocytes Percentage Over Time | 7 years | 1.7 Percentage of reticulocytes | Standard Deviation 1 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Reticulocytes Percentage Over Time | 8 years | 2.2 Percentage of reticulocytes | Standard Deviation 2.8 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Reticulocytes Percentage Over Time | 3 years | 1.3 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Reticulocytes Percentage Over Time | 5 years | 1.4 Percentage of reticulocytes | Standard Deviation 0.4 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Reticulocytes Percentage Over Time | 2 years | 1.2 Percentage of reticulocytes | Standard Deviation 0.4 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Reticulocytes Percentage Over Time | 6 years | 1.4 Percentage of reticulocytes | Standard Deviation 0.4 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Reticulocytes Percentage Over Time | 1 year | 1.3 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Reticulocytes Percentage Over Time | 8 years | 1.6 Percentage of reticulocytes | Standard Deviation 0.8 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Reticulocytes Percentage Over Time | 7 years | 1.3 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Reticulocytes Percentage Over Time | 6 months | 1.2 Percentage of reticulocytes | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Reticulocytes Percentage Over Time | 4 years | 1.2 Percentage of reticulocytes | Standard Deviation 0.4 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Reticulocytes Percentage Over Time | 6 months | 1.1 Percentage of reticulocytes | Standard Deviation 0.4 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Reticulocytes Percentage Over Time | 3 years | 1.2 Percentage of reticulocytes | Standard Deviation 0.6 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Reticulocytes Percentage Over Time | 5 years | 1.3 Percentage of reticulocytes | Standard Deviation 0.5 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Reticulocytes Percentage Over Time | 2 years | 2.9 Percentage of reticulocytes | Standard Deviation 4.9 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Reticulocytes Percentage Over Time | 4 years | 1.1 Percentage of reticulocytes | Standard Deviation 0.4 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Reticulocytes Percentage Over Time | 8 years | 1.5 Percentage of reticulocytes | Standard Deviation 0.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Reticulocytes Percentage Over Time | 7 years | 1.2 Percentage of reticulocytes | Standard Deviation 0.2 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Reticulocytes Percentage Over Time | 6 years | 1.1 Percentage of reticulocytes | Standard Deviation 0.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Reticulocytes Percentage Over Time | 1 year | 1.2 Percentage of reticulocytes | Standard Deviation 0.6 |
Secondary
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time
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.
Time frame: 6 months post-implant
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time | Baseline | 63.1 units on a scale | Standard Deviation 20.7 |
| Device - CEP Mitral Valve | Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time | 6 months | 75.4 units on a scale | Standard Deviation 17.8 |
Secondary
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time
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.
Time frame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. The protocol allowed subjects to have the option of having (haptoglobin and SLDH tests) or alternatively a plasma free hemoglobin test at each timeframe. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 4 years | 243.0 U/L | Standard Deviation 53.1 |
| Device - CEP Mitral Valve | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 2 years | 228.7 U/L | Standard Deviation 54 |
| Device - CEP Mitral Valve | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 5 years | 227.3 U/L | Standard Deviation 23.7 |
| Device - CEP Mitral Valve | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 1 year | 232.7 U/L | Standard Deviation 44 |
| Device - CEP Mitral Valve | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 6 years | 256.7 U/L | Standard Deviation 71.3 |
| Device - CEP Mitral Valve | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 6 months | 241.4 U/L | Standard Deviation 48.4 |
| Device - CEP Mitral Valve | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 3 years | 243.1 U/L | Standard Deviation 41.4 |
| Device - CEP Mitral Valve | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 8 years | 253.0 U/L | — |
| Device - CEP Mitral Valve - 27mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 8 years | 254.5 U/L | Standard Deviation 56.1 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 3 years | 227.0 U/L | Standard Deviation 66 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 5 years | 227.3 U/L | Standard Deviation 42.5 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 4 years | 220.1 U/L | Standard Deviation 45 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 1 year | 250.2 U/L | Standard Deviation 100.4 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 6 months | 247.3 U/L | Standard Deviation 100.1 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 7 years | 202.5 U/L | Standard Deviation 109.7 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 6 years | 248.5 U/L | Standard Deviation 94.4 |
| Device - CEP Mitral Valve - 27mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 2 years | 231.9 U/L | Standard Deviation 82 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 5 years | 221.4 U/L | Standard Deviation 31.3 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 6 months | 322.5 U/L | Standard Deviation 189.8 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 1 year | 294.5 U/L | Standard Deviation 145 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 2 years | 263.8 U/L | Standard Deviation 103.1 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 3 years | 274.7 U/L | Standard Deviation 102 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 4 years | 247.8 U/L | Standard Deviation 33.7 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 6 years | 245.3 U/L | Standard Deviation 33.8 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 7 years | 255.8 U/L | Standard Deviation 24.2 |
| Device - CEP Mitral Valve - 29mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 8 years | 257.4 U/L | Standard Deviation 28.4 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 3 years | 240.2 U/L | Standard Deviation 56.4 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 5 years | 238.5 U/L | Standard Deviation 19.1 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 2 years | 209.1 U/L | Standard Deviation 51.6 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 6 years | 269.3 U/L | Standard Deviation 43 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 1 year | 229.5 U/L | Standard Deviation 103.1 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 8 years | 369.7 U/L | Standard Deviation 189.7 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 7 years | 254.0 U/L | Standard Deviation 22 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 6 months | 274.2 U/L | Standard Deviation 141 |
| Device - CEP Mitral Valve - 31mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 4 years | 251.0 U/L | Standard Deviation 43.7 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 6 months | 300.5 U/L | Standard Deviation 182 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 2 years | 405.3 U/L | Standard Deviation 219.8 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 4 years | 286.0 U/L | Standard Deviation 127.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 5 years | 287.0 U/L | Standard Deviation 118.8 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 3 years | 332.5 U/L | Standard Deviation 149.2 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 1 year | 472.3 U/L | Standard Deviation 223.8 |
| Device - CEP Mitral Valve - 33mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 8 years | 423.0 U/L | — |
| Device - CEP Mitral Valve - 33mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 7 years | 200.0 U/L | — |
| Device - CEP Mitral Valve - 33mm | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time | 6 years | 393 U/L | — |
Secondary
Subject's Average White Blood Cell Count
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.
Time frame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device - CEP Mitral Valve | Subject's Average White Blood Cell Count | 8 years | 6.0 10^3 cells/uL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve | Subject's Average White Blood Cell Count | 4 years | 6.9 10^3 cells/uL | Standard Deviation 2.7 |
| Device - CEP Mitral Valve | Subject's Average White Blood Cell Count | 1 year | 7.1 10^3 cells/uL | Standard Deviation 2 |
| Device - CEP Mitral Valve | Subject's Average White Blood Cell Count | 5 years | 6.2 10^3 cells/uL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve | Subject's Average White Blood Cell Count | 7 years | 6.8 10^3 cells/uL | Standard Deviation 2.3 |
| Device - CEP Mitral Valve | Subject's Average White Blood Cell Count | 2 years | 6.9 10^3 cells/uL | Standard Deviation 2.4 |
| Device - CEP Mitral Valve | Subject's Average White Blood Cell Count | 6 years | 6.4 10^3 cells/uL | Standard Deviation 2 |
| Device - CEP Mitral Valve | Subject's Average White Blood Cell Count | 3 years | 6.5 10^3 cells/uL | Standard Deviation 2.4 |
| Device - CEP Mitral Valve | Subject's Average White Blood Cell Count | 6 months | 6.9 10^3 cells/uL | Standard Deviation 1.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average White Blood Cell Count | 6 years | 7.0 10^3 cells/uL | Standard Deviation 1.6 |
| Device - CEP Mitral Valve - 27mm | Subject's Average White Blood Cell Count | 5 years | 6.8 10^3 cells/uL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve - 27mm | Subject's Average White Blood Cell Count | 3 years | 6.8 10^3 cells/uL | Standard Deviation 1.8 |
| Device - CEP Mitral Valve - 27mm | Subject's Average White Blood Cell Count | 4 years | 6.9 10^3 cells/uL | Standard Deviation 1.9 |
| Device - CEP Mitral Valve - 27mm | Subject's Average White Blood Cell Count | 2 years | 6.8 10^3 cells/uL | Standard Deviation 1.9 |
| Device - CEP Mitral Valve - 27mm | Subject's Average White Blood Cell Count | 8 years | 7.0 10^3 cells/uL | Standard Deviation 2.1 |
| Device - CEP Mitral Valve - 27mm | Subject's Average White Blood Cell Count | 1 year | 6.9 10^3 cells/uL | Standard Deviation 2 |
| Device - CEP Mitral Valve - 27mm | Subject's Average White Blood Cell Count | 6 months | 6.9 10^3 cells/uL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve - 27mm | Subject's Average White Blood Cell Count | 7 years | 7.2 10^3 cells/uL | Standard Deviation 2.2 |
| Device - CEP Mitral Valve - 29mm | Subject's Average White Blood Cell Count | 5 years | 7.3 10^3 cells/uL | Standard Deviation 2.2 |
| Device - CEP Mitral Valve - 29mm | Subject's Average White Blood Cell Count | 6 months | 7.2 10^3 cells/uL | Standard Deviation 2.1 |
| Device - CEP Mitral Valve - 29mm | Subject's Average White Blood Cell Count | 1 year | 7.1 10^3 cells/uL | Standard Deviation 1.8 |
| Device - CEP Mitral Valve - 29mm | Subject's Average White Blood Cell Count | 2 years | 7.2 10^3 cells/uL | Standard Deviation 2 |
| Device - CEP Mitral Valve - 29mm | Subject's Average White Blood Cell Count | 3 years | 7.0 10^3 cells/uL | Standard Deviation 2.2 |
| Device - CEP Mitral Valve - 29mm | Subject's Average White Blood Cell Count | 4 years | 7.6 10^3 cells/uL | Standard Deviation 2.6 |
| Device - CEP Mitral Valve - 29mm | Subject's Average White Blood Cell Count | 6 years | 6.9 10^3 cells/uL | Standard Deviation 2.1 |
| Device - CEP Mitral Valve - 29mm | Subject's Average White Blood Cell Count | 7 years | 7.0 10^3 cells/uL | Standard Deviation 2.2 |
| Device - CEP Mitral Valve - 29mm | Subject's Average White Blood Cell Count | 8 years | 7.9 10^3 cells/uL | Standard Deviation 2.1 |
| Device - CEP Mitral Valve - 31mm | Subject's Average White Blood Cell Count | 3 years | 7.1 10^3 cells/uL | Standard Deviation 2.2 |
| Device - CEP Mitral Valve - 31mm | Subject's Average White Blood Cell Count | 5 years | 6.8 10^3 cells/uL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve - 31mm | Subject's Average White Blood Cell Count | 2 years | 6.5 10^3 cells/uL | Standard Deviation 1.8 |
| Device - CEP Mitral Valve - 31mm | Subject's Average White Blood Cell Count | 6 years | 7.4 10^3 cells/uL | Standard Deviation 1.8 |
| Device - CEP Mitral Valve - 31mm | Subject's Average White Blood Cell Count | 1 year | 7.5 10^3 cells/uL | Standard Deviation 2 |
| Device - CEP Mitral Valve - 31mm | Subject's Average White Blood Cell Count | 8 years | 5.8 10^3 cells/uL | Standard Deviation 1.5 |
| Device - CEP Mitral Valve - 31mm | Subject's Average White Blood Cell Count | 7 years | 6.7 10^3 cells/uL | Standard Deviation 2.1 |
| Device - CEP Mitral Valve - 31mm | Subject's Average White Blood Cell Count | 6 months | 7.1 10^3 cells/uL | Standard Deviation 2.2 |
| Device - CEP Mitral Valve - 31mm | Subject's Average White Blood Cell Count | 4 years | 6.5 10^3 cells/uL | Standard Deviation 1.6 |
| Device - CEP Mitral Valve - 33mm | Subject's Average White Blood Cell Count | 6 months | 6.7 10^3 cells/uL | Standard Deviation 1.2 |
| Device - CEP Mitral Valve - 33mm | Subject's Average White Blood Cell Count | 3 years | 6.1 10^3 cells/uL | Standard Deviation 1.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average White Blood Cell Count | 5 years | 6.9 10^3 cells/uL | Standard Deviation 3.8 |
| Device - CEP Mitral Valve - 33mm | Subject's Average White Blood Cell Count | 2 years | 5.8 10^3 cells/uL | Standard Deviation 1.2 |
| Device - CEP Mitral Valve - 33mm | Subject's Average White Blood Cell Count | 4 years | 6.0 10^3 cells/uL | Standard Deviation 1.3 |
| Device - CEP Mitral Valve - 33mm | Subject's Average White Blood Cell Count | 8 years | 6.6 10^3 cells/uL | Standard Deviation 1.1 |
| Device - CEP Mitral Valve - 33mm | Subject's Average White Blood Cell Count | 7 years | 6.1 10^3 cells/uL | Standard Deviation 1.7 |
| Device - CEP Mitral Valve - 33mm | Subject's Average White Blood Cell Count | 6 years | 5.9 10^3 cells/uL | Standard Deviation 1 |
| Device - CEP Mitral Valve - 33mm | Subject's Average White Blood Cell Count | 1 year | 7.2 10^3 cells/uL | Standard Deviation 1.3 |