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The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Experimental | Aortic valve replacement therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart Valve Surgery | Procedure | Implant of an aortic valve, Model 11000 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100 | Events occurring within 30 days of procedure |
| Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Number of late events divided by the total number of late patient years x 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Average Mean Gradient Measurements | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. | Baseline through 5-Year (at each scheduled follow-up visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Average White Blood Cell Count | Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection. | Baseline, 3-6 Months, and 1 through 5 Years |
| Subject's Average Red Blood Cells Count |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerzy Sadowski, MD | John Paul II Hospital | Principal Investigator |
| Jacek Rozanski, MD | The Cardinal Stefan Wyszyński Institute of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krakowski Szpital Specjalistyczny im. Jana Pawła II | Krakow | 31-202 | Poland | |||
| Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26182627 | Background | De La Fuente AB, Wright GA, Olin JM, Duhay FG, Kapelak B, Bochenek M, Bartus K, Sadowski J. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis. 2015 Jan;24(1):101-9. | |
| 29297188 | Result | Bartus K, Litwinowicz R, Kusmierczyk M, Bilewska A, Bochenek M, Stapor M, Wozniak S, Rozanski J, Sadowski J, Kapelak B. Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes. Kardiol Pol. 2018;76(3):618-624. doi: 10.5603/KP.a2017.0262. Epub 2018 Jan 3. |
Not provided
Not provided
133 Subjects were enrolled and implanted with the study valve, for which data is available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aortic Bioprosthesis, Model 11000 | Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Aortic Bioprosthesis, Model 11000 | Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000 |
| 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 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100 | Posted | Number | percentage | Events occurring within 30 days of procedure |
|
|
Events occurring from baseline through five years post implant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aortic Bioprosthesis, Model 11000 | Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia - non-bleeding related | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia - AV block - 1st degree | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Edwards, VP Clinical and Regulatory Affairs, Surgical Structural Heart | Edwards Lifesciences, LLC | 949-250-2500 | 1536 | mary_edwards@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 | May 8, 2012 | Apr 12, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001022 | Aortic Valve Insufficiency |
| D001024 | Aortic Valve Stenosis |
| D006333 | Heart Failure |
| D003324 | Coronary Artery Disease |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| Subject's Average Effective Orifice Area Measurements |
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. |
| Baseline through 5-Year (at each scheduled follow-up visit) |
| 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. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. | 3-6 Months and 1 through 5 Years compared to baseline |
| Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. | Baseline and one year follow-up |
| 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. | Baseline and 1 Year |
Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
| Baseline, 3-6 Months, and 1 through 5 Years |
| 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, 3-6 months, and 1 through 5 years |
| 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 fluid component(plasma) in the blood. | Baseline, 3-6 Months, and 1 through 5 Years |
| Subject's Average Platelet Count | Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting. | Baseline, 3-6 Months, and 1 through 5 Years |
| 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 liquid part of the blood (the serum). | Baseline, 3-6 Months, and 1 through 5 Years |
| Subject's Average Serum Creatinine | Laboratory Analysis of Serum Creatinine on blood drawn from subjects. Creatinine blood test is a test that measures kidney function. | Baseline |
| Subject's Average International Normalized Ratio | Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects. The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot. | Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years |
| Subject's Average Partial Thromboplastin Time | Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects. PTT is a blood test that looks at how long it takes for the blood to clot. | Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years |
| Subject's Average Prothrombin Time | Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects. The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot. | Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years |
| Warsaw |
| 04-628 |
| Poland |
| 25371311 | Result | Sadowski J, Bartus K, Kapelak B, Chung A, Stapor M, Bochenek M. Aortic valve replacement with a novel anti-calcification technology platform. Kardiol Pol. 2015;73(5):317-22. doi: 10.5603/KP.a2014.0214. Epub 2014 Nov 5. |
| 33141188 | Derived | Bartus K, Litwinowicz R, Bilewska A, Stapor M, Bochenek M, Rozanski J, Sadowski J, Filip G, Kusmierczyk M, Kapelak B. Final 5-year outcomes following aortic valve replacement with a RESILIA tissue bioprosthesis. Eur J Cardiothorac Surg. 2021 Jan 29;59(2):434-441. doi: 10.1093/ejcts/ezaa311. |
| Lost to Follow-up |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Number of late events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). | Posted | Number | Percentage of events/late patient years | Events occurring >= 31 days and up through 5 years post-implant |
|
|
|
| Secondary | Subject's Average Mean Gradient Measurements | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | mmHg | Baseline through 5-Year (at each scheduled follow-up visit) |
|
|
|
| Secondary | Subject's Average Effective Orifice Area Measurements | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | Centimeters squared | Baseline through 5-Year (at each scheduled follow-up visit) |
|
|
|
| Secondary | 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. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. | This outcome is reported for subjects who received the Model 11000 surgical aortic heart valve where data is available. | Posted | Count of Participants | Participants | 3-6 Months and 1 through 5 Years compared to baseline |
|
|
|
| Secondary | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | units on a scale | Baseline and one year follow-up |
|
|
|
| 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 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. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 Year |
|
|
|
| Other Pre-specified | Subject's Average White Blood Cell Count | Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | 10^3 cells/microliters | Baseline, 3-6 Months, and 1 through 5 Years |
|
|
|
| Other Pre-specified | Subject's Average Red Blood Cells Count | Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | 10^6 cells/microliters | Baseline, 3-6 Months, and 1 through 5 Years |
|
|
|
| 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. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | g/dl | Baseline, 3-6 months, and 1 through 5 years |
|
|
|
| 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 fluid component(plasma) in the blood. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | percentage of red blood cells | Baseline, 3-6 Months, and 1 through 5 Years |
|
|
|
| Other Pre-specified | Subject's Average Platelet Count | Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | 10^3 platelets per microliter | Baseline, 3-6 Months, and 1 through 5 Years |
|
|
|
| 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 liquid part of the blood (the serum). | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | mg/dl | Baseline, 3-6 Months, and 1 through 5 Years |
|
|
|
| Other Pre-specified | Subject's Average Serum Creatinine | Laboratory Analysis of Serum Creatinine on blood drawn from subjects. Creatinine blood test is a test that measures kidney function. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | micromol/l | Baseline |
|
|
|
| Other Pre-specified | Subject's Average International Normalized Ratio | Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects. The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | Ratio | Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years |
|
|
|
| Other Pre-specified | Subject's Average Partial Thromboplastin Time | Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects. PTT is a blood test that looks at how long it takes for the blood to clot. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | Seconds | Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years |
|
|
|
| Other Pre-specified | Subject's Average Prothrombin Time | Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects. The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot. | This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available. | Posted | Mean | Standard Deviation | Seconds | Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years |
|
|
|
| 21 |
| 133 |
| 74 |
| 133 |
| 41 |
| 133 |
| Angina, stable | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia-AV block III | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - AV block - 3rd degree | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - bradycardia | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - paroxysmal atrial fibrillation (PAF) | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - persistent atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - supraventricular tachycardia (SVT) | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - tachy-bradycardia | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - ventricular fibrillation | Cardiac disorders | Systematic Assessment |
|
| Biliary (gallbladder) | Gastrointestinal disorders | Systematic Assessment |
|
| Bleeding event | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bone fracture/break | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cancer - newly diagnosed | General disorders | Systematic Assessment |
|
| Cancer - progression of underlying disease | General disorders | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| Cardiac decompensation | Cardiac disorders | Systematic Assessment |
|
| Cardiovascular - other | Cardiac disorders | Systematic Assessment |
|
| Cardiovascular - other --> infection inflammation | Cardiac disorders | Systematic Assessment |
|
| Endocarditis | Cardiac disorders | Systematic Assessment |
|
| Endocrine complications | Endocrine disorders | Systematic Assessment |
|
| Gastrointestinal - other | Gastrointestinal disorders | Systematic Assessment |
|
| Genitourinary - other | Renal and urinary disorders | Systematic Assessment |
|
| Heart failure - chronic (CHF) | Cardiac disorders | Systematic Assessment |
|
| Hypertension - systemic | Cardiac disorders | Systematic Assessment |
|
| Muscular skeletal / dermatologic - other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Nonspecific, unknown or other body system - other complication | General disorders | Systematic Assessment |
|
| Pancreatic complication | Gastrointestinal disorders | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| Pericardial effusion - major | Cardiac disorders | Systematic Assessment |
|
| Pericardial effusion - minor | Cardiac disorders | Systematic Assessment |
|
| Pericardial tamponade - major | Cardiac disorders | Systematic Assessment |
|
| Pleural effusion - bilateral | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion - left | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pleural effusion - right | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary/respiratory - other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Renal - other | Renal and urinary disorders | Systematic Assessment |
|
| Renal dysfunction | Renal and urinary disorders | Systematic Assessment |
|
| Renal failure - acute | Renal and urinary disorders | Systematic Assessment |
|
| Renal failure - chronic | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory dysfunction/insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure - pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory infection - pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory infection - upper | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sternal wound/thoracic infection | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sudden death | General disorders | Systematic Assessment |
|
| Tachy-bradycardia | Cardiac disorders | Systematic Assessment |
|
| Thromboembolism | Cardiac disorders | Systematic Assessment |
|
| Transient psychotic syndrome | Psychiatric disorders | Systematic Assessment |
|
| Valve thrombosis | Cardiac disorders | Systematic Assessment |
|
| Vascular - other | Vascular disorders | Systematic Assessment |
|
| Vision disorder | Eye disorders | Systematic Assessment |
|
| Wound infection - other | Infections and infestations | Systematic Assessment |
|
| Arrhythmia - paroxysmal atrial fibrillation (PAF) | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - paroxysmal atrial tachycardia (PAT) | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - permanent atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - persistent atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia - tachy-bradycardia | Cardiac disorders | Systematic Assessment |
|
| Bleeding event | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiovascular - other | Cardiac disorders | Systematic Assessment |
|
| Non structural valve dysfunction | Cardiac disorders | Systematic Assessment |
|
| Nonspecific, unknown or other body system - other complication | General disorders | Systematic Assessment |
|
| Pericardial effusion - minor | Cardiac disorders | Systematic Assessment |
|
| Pleural effusion - right | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Renal dysfunction | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory infection - upper | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Stenosis - tricuspid - moderate | Cardiac disorders | Systematic Assessment |
|
| Transient psychotic syndrome | Psychiatric disorders | Systematic Assessment |
|
| Vision disorder | Eye disorders | Systematic Assessment |
|
PI can't publish/present on overall study results not yet published but may publish his own data subject to EW review prior to submission/presentation, but data analyses of site-specific results can occur only in intervals as specified in the CTA. Publication/presentation of the PI's site-specific results of devices which haven't been market released and which still may be undergoing development, shall not include claims of device safety/effectiveness and will require the review/approval of EW.
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| Title | Measurements |
|---|---|
|
| Explant |
|
| Thromboembolism |
|
| Valve Thrombosis |
|
| Bleeding Event |
|
| Major Bleeding Event |
|
| Paravalvular Leak (PVL) |
|
| Major Paravalvular Leak |
|
| Endocarditis |
|
| Hemolysis |
|
| Nonstructural Valve Dysfunction (Not PVL) |
|
| Structural Valve Deterioration |
|
|
| 3-6 months |
|
|
| 1 year |
|
|
| 2 year |
|
|
| 3 year |
|
|
| 4 year |
|
|
| 5 year |
|
|
|
| 3-6 Month |
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| Worse at 3-6 months |
|
|
| Improve at 1 Year |
|
|
| Same at 1 Year |
|
|
| Worse at 1 Year |
|
|
| Improve at 2 Years |
|
|
| Same at 2 Years |
|
|
| Worse at 2 Years |
|
|
| Improve at 3 Years |
|
|
| Same at 3 Years |
|
|
| Worse at 3 Years |
|
|
| Improve at 4 Years |
|
|
| Same at 4 Years |
|
|
| Worse at 4 Years |
|
|
| Improve at 5 Years |
|
|
| Same at 5 Years |
|
|
| Worse at 5 Years |
|
|
| Title | Measurements |
|---|---|
|
| Mental Health - 1 Year follow-up |
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 1 Year |
|
|
| 2 Years |
|
|
| 3 Years |
|
|
| 4 Years |
|
|
| 5 Years |
|
|
|
| 1 Year |
|
|
| 2 Years |
|
|
| 3 Years |
|
|
| 4 Years |
|
|
| 5 Years |
|
|
|
| 1 Year |
|
|
| 2 Years |
|
|
| 3 Years |
|
|
| 4 Years |
|
|
| 5 Years |
|
|
|
| 1 Year |
|
|
| 2 Years |
|
|
| 3 Years |
|
|
| 4 Years |
|
|
| 5 Years |
|
|
|
| 3-6 Months |
|
|
| 1 Year |
|
|
| 3 Years |
|
|
| 5 Years |
|
|
|
| 3-6 Months |
|
|
| 1 Year |
|
|
| 3 Years |
|
|
| 5 Years |
|
|
|
| 3-6 Months |
|
|
| 1 Year |
|
|
| 3 Years |
|
|
| 5 Years |
|
|