Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve.
This is a prospective, non-randomized, multi-site, descriptive study. A minimum of 15 and up to 20 subjects will be implanted at a minimum of 2 and up to 8 participating investigational sites within the US and internationally.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects receive implant | Other | Subjects serve as own control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of CEP Magna Mitral Model 7000TFX | Device | Heart valve surgery: CEP Magna Mitral Model 7000 TFX |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Early Adverse Events Divided | Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100. | Events occuring within 30 days of procedure |
| Percent of Late Adverse Events | Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). | Events occurring >= 31 days and up through 5 years post-implant |
| Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method. | >30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
| 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. | Pre-procedure and 1 Year post-Implant |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. Mean gradient values depend on the size and type of valve. | Pre-procedure and 1 Year post-implant |
| Subject's Average Peak Gradient Measurement |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital | Orlando | Florida | 32803 | United States | ||
| Northwestern Hospital |
Not provided
| Label | URL |
|---|---|
| New York Heart Association Classification | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Magna Mitral 23 | Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Magna Mitral 23 | Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Early Adverse Events Divided | Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Number | percentage of subjects | Events occuring within 30 days of procedure |
|
|
Events occurring from baseline through five years post implant
The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magna Mitral 23 | Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure - Acute | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscellaneous Complication | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart | Edwards Lifesciences, LLC | 949-250-2500 | 0225 | Andrey_Nersesov@edwards.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2011 | Dec 10, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| Pre-procedure and 1 Year post-implant |
| 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. | Pre-procedure and 1 Year post-implant |
| Subject's Average Performance Index Measurement | Performance index is defined as the subject's effective orifice area (the cross sectional area of the blood flow downstream of the mitral valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time. | Pre-procedure and 1 Year post-Implant |
| Subject's Average Cardiac Output | The amount of blood the heart pumps through the circulatory system in a minute. | Pre-procedure and 1 Year post-implant |
| Subject's Average Cardiac Index | Cardiac index is an assessment that divides the cardiac output from the left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual. | Pre-procedure and 1 Year post-implant |
| 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. | Pre-procedure and 1 Year post-implant |
| Subject's Severity of Central Mitral Regurgitation at 1 Year Post-implant. | Mitral valvular regurgitation occurs when the mitral valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. | 1 Year post-implant |
| Subject's Average Red Blood Cells Count | Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen. | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
| Subject's Average White Blood Cell Count | Laboratory analysis of White Blood Cell (WBC) Count on blood drawn from subject; WBC fight infection. | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
| Subject's Average Hematocrit Percentage | Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood). | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
| Subject's Average Plasma Free Hemoglobin | Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
| Subject's Average Hemoglobin Count | Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
| Subject's Average Platelet Count | Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting. | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
| Number and Percentage of Subjects in NYHA Functional Class I or II at 1 Year Post-Implant. | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). | Baseline and 1 Year post-implant |
| Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
| 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 is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. | 6 Months and 1 Year post-implant |
| Chicago |
| Illinois |
| 60611 |
| United States |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| The John Paul II Hospital in Krakow | Krakow | 31-202 | Poland |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Percent of Late Adverse Events | Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Number | percentage of events/late patient years | Events occurring >= 31 days and up through 5 years post-implant |
|
|
|
| Primary | Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Number | percentage of subjects | >30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
|
|
|
| Primary | 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. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | Centimeters Squared | Pre-procedure and 1 Year post-Implant |
|
|
|
| Other Pre-specified | 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. Mean gradient values depend on the size and type of valve. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | mmHg | Pre-procedure and 1 Year post-implant |
|
|
|
| Other Pre-specified | 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. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | mmHg | Pre-procedure and 1 Year post-implant |
|
|
|
| Other Pre-specified | 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. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | cm^2/m^2 | Pre-procedure and 1 Year post-implant |
|
|
|
| Other Pre-specified | Subject's Average Performance Index Measurement | Performance index is defined as the subject's effective orifice area (the cross sectional area of the blood flow downstream of the mitral valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | cm^2/cm^2 | Pre-procedure and 1 Year post-Implant |
|
|
|
| Other Pre-specified | Subject's Average Cardiac Output | The amount of blood the heart pumps through the circulatory system in a minute. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | Liters/minute | Pre-procedure and 1 Year post-implant |
|
|
|
| Other Pre-specified | Subject's Average Cardiac Index | Cardiac index is an assessment that divides the cardiac output from the left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | L/min/m2 | Pre-procedure and 1 Year post-implant |
|
|
|
| Other Pre-specified | 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. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | grams | Pre-procedure and 1 Year post-implant |
|
|
|
| Other Pre-specified | Subject's Severity of Central Mitral Regurgitation at 1 Year Post-implant. | Mitral valvular regurgitation occurs when the mitral valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Count of Participants | Participants | 1 Year post-implant |
|
|
|
| Other Pre-specified | Subject's Average Red Blood Cells Count | Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | 10^6 cells/microliters | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average White Blood Cell Count | Laboratory analysis of White Blood Cell (WBC) Count on blood drawn from subject; WBC fight infection. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | 10^3 cells /microliter | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Hematocrit Percentage | Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood). | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | percentage of red blood cells | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Plasma Free Hemoglobin | Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | mg/dl | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Hemoglobin Count | Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | g/dl | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Platelet Count | Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | 10^3 platelets per microliter | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Number and Percentage of Subjects in NYHA Functional Class I or II at 1 Year Post-Implant. | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Count of Participants | Participants | Baseline and 1 Year post-implant |
|
|
|
| Other Pre-specified | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Count of Participants | Participants | 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
|
|
|
| Other Pre-specified | 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 is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. | The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available. | Posted | Mean | Standard Deviation | units on a scale | 6 Months and 1 Year post-implant |
|
|
|
| 3 |
| 12 |
| 12 |
| 12 |
| 11 |
| 12 |
| Gastrointestinal - Other | Gastrointestinal disorders | Systematic Assessment |
|
| Heart Failure - Chronic (CHF) | Cardiac disorders | Systematic Assessment |
|
| Cancer - Newly Diagnosed | General disorders | Systematic Assessment |
|
| Miscellaneous Complication | General disorders | Systematic Assessment |
|
| Neurologic - Other | Psychiatric disorders | Systematic Assessment |
|
| Respiratory Infection - Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Other Infection/Inflammation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Arrhythmia - AV Block | Cardiac disorders | Systematic Assessment |
|
| Respiratory Dysfunction/Insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Anemia - Non-Bleeding Related | Blood and lymphatic system disorders | Systematic Assessment |
|
| Angina, Unstable | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - Atrial Flutter | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - Paroxysmal Atrial Fibrillation (PAF) | Cardiac disorders | Systematic Assessment |
|
| Biliary (Gallbladder) | Gastrointestinal disorders | Systematic Assessment |
|
| Bleeding - Cardiovascular | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
|
| Cardiovascular Other | Cardiac disorders | Systematic Assessment |
|
| Endocarditis | Cardiac disorders | Systematic Assessment |
|
| Endocrine Complications | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal - Infection (Diarrhea) | Gastrointestinal disorders | Systematic Assessment |
|
| Neurologic - Dizziness | Psychiatric disorders | Systematic Assessment |
|
| Non Structural Valve Dysfunction (NSVD) - Non-Perivalvular Leak | Cardiac disorders | Systematic Assessment |
|
| Psychiatric Disorder | Psychiatric disorders | Systematic Assessment |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Structural Valve Deterioration (SVD) | Cardiac disorders | Systematic Assessment |
|
| Thromboembolic Event - Transient Ischemic Attack (TIA) | Cardiac disorders | Systematic Assessment |
|
| Vascular - Other | Vascular disorders | Systematic Assessment |
|
| Thrombocytopenia - Non-Heparin Induced | Blood and lymphatic system disorders | Systematic Assessment |
|
| Gastrointestinal - Other | Gastrointestinal disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Infection - Upper (URI) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Anemia - Bleeding Related | Blood and lymphatic system disorders | Systematic Assessment |
|
| Skin/Skeletal/Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Anemia - Non-Bleeding Related | Blood and lymphatic system disorders | Systematic Assessment |
|
| Arrhythmia - Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Urinary Tract Infection (UTI) | Renal and urinary disorders | Systematic Assessment |
|
| Blood/Lymphatic/Other | Blood and lymphatic system disorders | Systematic Assessment |
|
| Respiratory Dysfunction/Insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Arrhythmia - Bundle Branch Block | Cardiac disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Other Infection/Inflammation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Arrhythmia - Atrial Flutter | Cardiac disorders | Systematic Assessment |
|
| Cardiovascular Other | Cardiac disorders | Systematic Assessment |
|
| Gastrointestinal - Infection (Diarrhea) | Gastrointestinal disorders | Systematic Assessment |
|
| Heart Failure - Acute | Cardiac disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Neurologic - Dizziness | Psychiatric disorders | Systematic Assessment |
|
| Neurologic - Other | Psychiatric disorders | Systematic Assessment |
|
| Renal - Other | Renal and urinary disorders | Systematic Assessment |
|
| Arrhythmia - AV Block | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - Tachy-Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Bleeding - Cardiovascular | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bleeding - Peripheral Vascular (E.G. Nosebleeds; Hematomas) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cancer - Newly Diagnosed | General disorders | Systematic Assessment |
|
| Cancer - Progression Of Underlying Disease | General disorders | Systematic Assessment |
|
| Endocrine Complications | Gastrointestinal disorders | Systematic Assessment |
|
| Hepatic - Complication | Gastrointestinal disorders | Systematic Assessment |
|
| Minor (<=+2) Paravalvular Leak | Cardiac disorders | Systematic Assessment |
|
| Neurologic - Syncope | Psychiatric disorders | Systematic Assessment |
|
| Pulmonary/Respiratory Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Infection - Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Thrombocytopenia - Heparin Induced (HIT) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Transient Psychotic Syndrome | Psychiatric disorders | Systematic Assessment |
|
| Vaginal Infection | Renal and urinary disorders | Systematic Assessment |
|
| Valve - Other | Cardiac disorders | Systematic Assessment |
|
| Vascular - Other | Vascular disorders | Systematic Assessment |
|
| Vision Disorder | General disorders | Systematic Assessment |
|
Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 30 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 60 day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.
| Title | Measurements |
|---|---|
|
| Valve Thrombosis |
|
| Hemorrhage |
|
| Major Hemorrhage |
|
| Non-Structural Valve Dysfunction (study valve) |
|
| All Clinically Significant PVL |
|
| Major Clinically Significant PVL |
|
| Hemolysis |
|
| Endocarditis |
|
| Structural Valve Deterioration |
|
| Reoperation |
|
| Explant |
|
| Valve-related Death |
|
| Reoperation |
|
| Explant |
|
| Bleeding Event |
|
| Major Bleeding Event |
|
| Thromboembolism |
|
| Endocarditis |
|
| Perivalvular Leak |
|
| Major Perivalvular Leak |
|
| Hemolysis |
|
| Non-structural Valve Dysfunction |
|
| Structural Valve Deterioration |
|
| Valve Thrombosis |
|
|
|
|
|
|
|
|
|
| Title | Measurements |
|---|
|
| +3 Modearte |
|
| +4 Severe |
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
| Worsened |
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 1 Year |
|
|