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Interventional study to evaluate the safety and efficacy of the Medtronic CoreValveâ„¢ Evolutâ„¢ PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR).
The study is targeting 6 centers with a maximum of 8 centers in China and estimating 65 subjects with a maximum of up to 70 subjects with attempted implants including 50 subjects with an attempted implant in primary study population and the first two attempted subjects at each site for roll-in population. The subjects will follow the assessment with pre and post-procedure, discharge, 30 days(primary endpoint), 6 months, 1 year, and annually through 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medtronic CoreValveâ„¢ Evolutâ„¢ PRO System | Experimental | The system comprised of the following three components:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic CoreValveâ„¢ Evolutâ„¢ PRO System | Device | The system comprised of the following three components:
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | All-cause mortality at 30 days | 30 days |
| Percentage (%) of Subjects With Evaluable Echocardiograms With Moderate or Severe Aortic Regurgitation by Transthoracic Echocardiography (TTE) | Percentage (%) of Subjects with evaluable echocardiograms with moderate or severe aortic regurgitation by transthoracic echocardiography (TTE) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of an VARC II Combined Composite | Incidence of an VARC II combined composite includes the following components:
|
| Measure | Description | Time Frame |
|---|---|---|
| Event Rates of TAVI-related Complications | Rate of the following TAVI-related complications:
| 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianan Wang, MD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing Municipality | 100000 | China | ||
| Chinese PLA General Hospital, Chinese PLA Medical School |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Medtronic CoreValveâ„¢ Evolutâ„¢ PRO System | Subjects treated with the Medtronic CoreValveâ„¢ Evolutâ„¢ PRO System. Primary Study Population: 52 enrolled subjects, 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Primary Study Population consisted of 50 participants with an attempted implant
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Medtronic CoreValveâ„¢ Evolutâ„¢ PRO System | Subjects treated with the Medtronic CoreValveâ„¢ Evolutâ„¢ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study. |
| 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 | All-cause Mortality | All-cause mortality at 30 days | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 30 days |
|
|
Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure.
All AEs that occur during the study need to be collected by investigator or designee.
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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 | Experimental: Medtronic CoreValveâ„¢ Evolutâ„¢ PRO System | Subjects treated with the Medtronic CoreValveâ„¢ Evolutâ„¢ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fairy Liu | Medtronic, Inc. | +86-02120325765 | rs.evolutprochinaclinicalstudy@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Study Protocol V4.0 | Jul 13, 2022 | Feb 17, 2024 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Study Protocol V3.0 | Dec 18, 2020 | Feb 17, 2024 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Study Protocol V2.0 | Jun 19, 2019 | Feb 17, 2024 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: Study Protocol V5.0 | Oct 6, 2023 | Feb 28, 2025 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: V2.0 | Apr 18, 2022 | Feb 17, 2024 | SAP_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: V3.0 | Feb 7, 2024 | Feb 28, 2025 | SAP_005.pdf |
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| 30 days |
| Event Rates of the Individual Components of the VARC II Composite | Event rate of the individual components listed in the outcome | 30 days |
| New Permanent Pacemaker Rate | New permanent pacemaker rate | 30 days |
| Device Success Rate | Device success rate:
| Between 24 hours and 7 days post procedure |
| Valve Performance Parameter - Mean Aortic Gradient | Mean aortic gradient | 30 days |
| Valve Performance Parameter - Effective Orifice Area | Effective orifice area | 30 days |
| Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Degree of aortic regurgitation (transvalvular, paravalvular, total) | 30 days |
| All-cause Mortality | Percentage of participants with all-cause mortality | 6 months |
| All-cause Mortality | Percentage of participants with all-cause mortality | 1 year |
| All Stroke | Incidence of stroke (disabling and non-disabling) | 6 months |
| All Stroke | Incidence of stroke (disabling and non-disabling) | 1 year |
| Myocardial Infarction | Incidence of MI | 30 days |
| Myocardial Infarction | Incidence of MI | 6 months |
| Myocardial Infarction | Incidence of MI | 1 Year |
| Incidence of Life-threatening Bleeding | Incidence of life-threatening bleeding:
| 30 days |
| Incidence of Life-threatening Bleeding | Incidence of life-threatening bleeding:
| 6 months |
| Incidence of Life-threatening Bleeding | Incidence of life-threatening bleeding:
| 1 Year |
| New AV-Conduction Disturbances (Left Bundle Branch Block (LBBB) and Right Bundle Branch Block (RBBB)) | Incidence of either LBBB or RBBB | 30 days |
| Incidence of Prosthetic Valve Endocarditis | Incidence of prosthetic valve endocarditis: Any one of the following:
| 30 days |
| Incidence of Prosthetic Valve Endocarditis | Incidence of prosthetic valve endocarditis: Any one of the following:
| 6 months |
| Incidence of Prosthetic Valve Endocarditis | Incidence of prosthetic valve endocarditis: Any one of the following:
| 1 Year |
| Incidence of Prosthetic Valve Thrombosis | Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis. | 30 days |
| Incidence of Prosthetic Valve Thrombosis | Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis. | 6 months |
| Incidence of Prosthetic Valve Thrombosis | Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis. | 1 Year |
| Valve-related Dysfunction | Incidence of valve-related dysfunction defined as moderate or severe prosthetic valve stenosis, or moderate or severe prosthetic regurgitation (per VARC II) | 1 Year |
| Incidence of Valve-related Dysfunction Requiring Repeat Procedure | Incidence of Valve-related dysfunction requiring repeat procedure | 30 days |
| Incidence of Valve-related Dysfunction Requiring Repeat Procedure | Incidence of Valve-related dysfunction requiring repeat procedure | 6 months |
| Incidence of Valve-related Dysfunction Requiring Repeat Procedure | Incidence of Valve-related dysfunction requiring repeat procedure | 1 Year |
| Valve Hemodynamic Performance Metric - Mean Aortic Gradient | Mean aortic gradient | 1 year |
| Valve Hemodynamic Performance Metric - Effective Orifice Area | Effective orifice area | 1 year |
| Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Degree of aortic regurgitation (transvalvular, paravalvular, total) | 1 year |
| New York Heart Association (NYHA) Functional Classification | New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest). Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. | 30 days |
| New York Heart Association (NYHA) Functional Classification | New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest). Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. | 6 month |
| New York Heart Association (NYHA) Functional Classification | New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest). Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. | 1 Year |
| EQ-5D Quality of Life | EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine). | 30 days |
| EQ-5D Quality of Life | EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine). | 1 Year |
| All-cause Mortality | Percentage of participants with all-cause mortality | 2 year |
| All Stroke | Incidence of stroke (disabling and non-disabling) | 2 year |
| Myocardial Infarction | Incidence of MI | 2 Year |
| Incidence of Life-threatening Bleeding | Incidence of life-threatening bleeding:
| 2 Year |
| Incidence of Prosthetic Valve Endocarditis | Incidence of prosthetic valve endocarditis: Any one of the following:
| 2 Year |
| Incidence of Prosthetic Valve Thrombosis | Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis. | 2 Year |
| Valve-related Dysfunction | Incidence of valve-related dysfunction defined as moderate or severe prosthetic valve stenosis, or moderate or severe prosthetic regurgitation (per VARC II) | 2 Year |
| Incidence of Valve-related Dysfunction Requiring Repeat Procedure | Incidence of Valve-related dysfunction requiring repeat procedure | 2 Year |
| Valve Hemodynamic Performance Metric - Mean Aortic Gradient | Mean aortic gradient | 2 year |
| Valve Hemodynamic Performance Metric - Effective Orifice Area | Effective orifice area | 2 year |
| Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Degree of aortic regurgitation (transvalvular, paravalvular, total) | 2 year |
| New York Heart Association (NYHA) Functional Classification | New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest). Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. | 2 Year |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610000 | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| BSA | Mean | Standard Deviation | m^2 |
|
| NYHA | New York Heart Association (NYHA) Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Count of Participants | Participants |
|
| STS Score | The Society of Thoracic Surgeons (STS) Score is a score that represents the risk of operative mortality, major morbidity, and complications for adult cardiac surgeries. A total STS Score, presented as a risk probability on a scale of 0-100%, is calculated based on patient characteristics. The STS Score is calculated before a patient undergoes the transcatheter aortic valve replacement (TAVR) index procedure in the study, and a higher STS Score means a patient is at higher risk for surgery. | Mean | Standard Deviation | % |
|
| Participants |
|
|
| Primary | Percentage (%) of Subjects With Evaluable Echocardiograms With Moderate or Severe Aortic Regurgitation by Transthoracic Echocardiography (TTE) | Percentage (%) of Subjects with evaluable echocardiograms with moderate or severe aortic regurgitation by transthoracic echocardiography (TTE) | Number of subjects with evaluable aortic regurgitation from echo core lab | Posted | Number | 95% Confidence Interval | Percentage (%) of participants | 30 days |
|
|
|
| Secondary | Incidence of an VARC II Combined Composite | Incidence of an VARC II combined composite includes the following components:
| Number of attempted implant population | Posted | Number | 95% Confidence Interval | Percent of Participants (K-M Rate) | 30 days |
|
|
|
| Secondary | Event Rates of the Individual Components of the VARC II Composite | Event rate of the individual components listed in the outcome | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 30 days |
|
|
|
| Secondary | New Permanent Pacemaker Rate | New permanent pacemaker rate | Number of attempted implant population. Subjects with a pacemaker or ICD at baseline are excluded. | Posted | Number | 95% Confidence Interval | Percent of Participants (K-M Rate) | 30 days |
|
|
|
| Secondary | Device Success Rate | Device success rate:
| Number of attempted implant subjects with evaluable data for device success | Posted | Number | 95% Confidence Interval | Percentage (%) of participants | Between 24 hours and 7 days post procedure |
|
|
|
| Secondary | Valve Performance Parameter - Mean Aortic Gradient | Mean aortic gradient | Number of implanted subjects with echo core lab evaluable values | Posted | Mean | Standard Deviation | mmHg | 30 days |
|
|
|
| Secondary | Valve Performance Parameter - Effective Orifice Area | Effective orifice area | Number of implanted subjects with echo core lab evaluable values | Posted | Mean | Standard Deviation | cm^2 | 30 days |
|
|
|
| Secondary | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Degree of aortic regurgitation (transvalvular, paravalvular, total) | Number of implanted subjects with echo core lab evaluable values | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Other Pre-specified | Event Rates of TAVI-related Complications | Rate of the following TAVI-related complications:
| Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 30 days |
|
|
|
| Other Pre-specified | All-cause Mortality | Percentage of participants with all-cause mortality | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 6 months |
|
|
|
| Other Pre-specified | All-cause Mortality | Percentage of participants with all-cause mortality | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 1 year |
|
|
|
| Other Pre-specified | All Stroke | Incidence of stroke (disabling and non-disabling) | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 6 months |
|
|
|
| Other Pre-specified | All Stroke | Incidence of stroke (disabling and non-disabling) | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 1 year |
|
|
|
| Other Pre-specified | Myocardial Infarction | Incidence of MI | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 30 days |
|
|
|
| Other Pre-specified | Myocardial Infarction | Incidence of MI | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 6 months |
|
|
|
| Other Pre-specified | Myocardial Infarction | Incidence of MI | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 1 Year |
|
|
|
| Other Pre-specified | Incidence of Life-threatening Bleeding | Incidence of life-threatening bleeding:
| Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 30 days |
|
|
|
| Other Pre-specified | Incidence of Life-threatening Bleeding | Incidence of life-threatening bleeding:
| Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 6 months |
|
|
|
| Other Pre-specified | Incidence of Life-threatening Bleeding | Incidence of life-threatening bleeding:
| Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 1 Year |
|
|
|
| Other Pre-specified | New AV-Conduction Disturbances (Left Bundle Branch Block (LBBB) and Right Bundle Branch Block (RBBB)) | Incidence of either LBBB or RBBB | Number of attempted implant population. Subjects with LBBB or RBBB at baseline are excluded | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Other Pre-specified | Incidence of Prosthetic Valve Endocarditis | Incidence of prosthetic valve endocarditis: Any one of the following:
| Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 30 days |
|
|
|
| Other Pre-specified | Incidence of Prosthetic Valve Endocarditis | Incidence of prosthetic valve endocarditis: Any one of the following:
| Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 6 months |
|
|
|
| Other Pre-specified | Incidence of Prosthetic Valve Endocarditis | Incidence of prosthetic valve endocarditis: Any one of the following:
| Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 1 Year |
|
|
|
| Other Pre-specified | Incidence of Prosthetic Valve Thrombosis | Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis. | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 30 days |
|
|
|
| Other Pre-specified | Incidence of Prosthetic Valve Thrombosis | Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis. | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 6 months |
|
|
|
| Other Pre-specified | Incidence of Prosthetic Valve Thrombosis | Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis. | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 1 Year |
|
|
|
| Other Pre-specified | Valve-related Dysfunction | Incidence of valve-related dysfunction defined as moderate or severe prosthetic valve stenosis, or moderate or severe prosthetic regurgitation (per VARC II) | Number of implanted subjects with evaluable site-reported echo data | Posted | Count of Participants | Participants | 1 Year |
|
|
|
| Other Pre-specified | Incidence of Valve-related Dysfunction Requiring Repeat Procedure | Incidence of Valve-related dysfunction requiring repeat procedure | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 30 days |
|
|
|
| Other Pre-specified | Incidence of Valve-related Dysfunction Requiring Repeat Procedure | Incidence of Valve-related dysfunction requiring repeat procedure | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 6 months |
|
|
|
| Other Pre-specified | Incidence of Valve-related Dysfunction Requiring Repeat Procedure | Incidence of Valve-related dysfunction requiring repeat procedure | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 1 Year |
|
|
|
| Other Pre-specified | Valve Hemodynamic Performance Metric - Mean Aortic Gradient | Mean aortic gradient | Number of implanted subjects with site reported echo evaluable data | Posted | Mean | Standard Deviation | mmHg | 1 year |
|
|
|
| Other Pre-specified | Valve Hemodynamic Performance Metric - Effective Orifice Area | Effective orifice area | Number of implanted subjects with site reported echo evaluable data | Posted | Mean | Standard Deviation | cm^2 | 1 year |
|
|
|
| Other Pre-specified | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Degree of aortic regurgitation (transvalvular, paravalvular, total) | Number of implanted subjects with site reported echo evaluable data | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Other Pre-specified | New York Heart Association (NYHA) Functional Classification | New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest). Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Number of attempted subjects with available NYHA | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Other Pre-specified | New York Heart Association (NYHA) Functional Classification | New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest). Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Number of attempted subjects with available NYHA | Posted | Count of Participants | Participants | 6 month |
|
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| Other Pre-specified | New York Heart Association (NYHA) Functional Classification | New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest). Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Number of attempted subjects with available NYHA | Posted | Count of Participants | Participants | 1 Year |
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| Other Pre-specified | EQ-5D Quality of Life | EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine). | Number of attempted subjects with available EQ5D | Posted | Mean | Standard Deviation | Score on a scale | 30 days |
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| Other Pre-specified | EQ-5D Quality of Life | EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine). | Number of attempted subjects with available EQ5D | Posted | Mean | Standard Deviation | Score on a scale | 1 Year |
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| Other Pre-specified | All-cause Mortality | Percentage of participants with all-cause mortality | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 2 year |
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| Other Pre-specified | All Stroke | Incidence of stroke (disabling and non-disabling) | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 2 year |
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| Other Pre-specified | Myocardial Infarction | Incidence of MI | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 2 Year |
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| Other Pre-specified | Incidence of Life-threatening Bleeding | Incidence of life-threatening bleeding:
| Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 2 Year |
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| Other Pre-specified | Incidence of Prosthetic Valve Endocarditis | Incidence of prosthetic valve endocarditis: Any one of the following:
| Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 2 Year |
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| Other Pre-specified | Incidence of Prosthetic Valve Thrombosis | Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis. | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 2 Year |
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| Other Pre-specified | Valve-related Dysfunction | Incidence of valve-related dysfunction defined as moderate or severe prosthetic valve stenosis, or moderate or severe prosthetic regurgitation (per VARC II) | Number of implanted subjects with evaluable site-reported echo data | Posted | Count of Participants | Participants | 2 Year |
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| Other Pre-specified | Incidence of Valve-related Dysfunction Requiring Repeat Procedure | Incidence of Valve-related dysfunction requiring repeat procedure | Number of attempted implant population | Posted | Number | Percent of Participants (K-M Rate) | 2 Year |
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| Other Pre-specified | Valve Hemodynamic Performance Metric - Mean Aortic Gradient | Mean aortic gradient | Number of implanted subjects with site reported echo evaluable data | Posted | Mean | Standard Deviation | mmHg | 2 year |
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| Other Pre-specified | Valve Hemodynamic Performance Metric - Effective Orifice Area | Effective orifice area | Number of implanted subjects with site reported echo evaluable data | Posted | Mean | Standard Deviation | cm^2 | 2 year |
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| Other Pre-specified | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Degree of aortic regurgitation (transvalvular, paravalvular, total) | Number of implanted subjects with site reported echo evaluable data | Posted | Count of Participants | Participants | 2 year |
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| Other Pre-specified | New York Heart Association (NYHA) Functional Classification | New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest). Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Number of attempted subjects with available NYHA | Posted | Count of Participants | Participants | 2 Year |
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| 5 |
| 50 |
| 28 |
| 50 |
| 39 |
| 50 |
| Atrioventricular block second degree | Cardiac disorders | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | Systematic Assessment |
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| Coronary ostial stenosis | Cardiac disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Blood pressure decreased | Investigations | Systematic Assessment |
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| PaO2/FiO2 ratio decreased | Investigations | Systematic Assessment |
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| Device dislocation | Product Issues | Systematic Assessment |
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| Arteriosclerosis Coronary Artery | Cardiac disorders | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Ventricular Extrasystoles | Cardiac disorders | Systematic Assessment |
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| Cataract | Eye disorders | Systematic Assessment |
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| Functional Gastrointestinal Disorder | Gastrointestinal disorders | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Multiple Organ Dysfunction Syndrome | General disorders | Systematic Assessment |
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| Bile Duct Stone | Hepatobiliary disorders | Systematic Assessment |
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| Cholecystitis Chronic | Hepatobiliary disorders | Systematic Assessment |
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| Hepatic Cirrhosis | Hepatobiliary disorders | Systematic Assessment |
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| Cholangitis Infective | Infections and infestations | Systematic Assessment |
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| Coronavirus Pneumonia | Infections and infestations | Systematic Assessment |
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| Lower Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
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| Urethritis | Infections and infestations | Systematic Assessment |
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| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Cerebral Haemorrhage | Nervous system disorders | Systematic Assessment |
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| Cerebral Infarction | Nervous system disorders | Systematic Assessment |
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| Chronic Kidney Disease | Renal and urinary disorders | Systematic Assessment |
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| Nephrotic Syndrome | Renal and urinary disorders | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Shoulder Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Endocarditis Bacterial | Infections and infestations | Systematic Assessment |
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| Pneumonia Klebsiella | Infections and infestations | Systematic Assessment |
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| Pneumonia Pneumococcal | Infections and infestations | Systematic Assessment |
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| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrioventricular block first degree | Cardiac disorders | Systematic Assessment |
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| Bundle branch block left | Cardiac disorders | Systematic Assessment |
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| Myocardial injury | Cardiac disorders | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoproteinaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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Within 60 days of receipt Medtronic (MDT) will verify presence of Confidential Information (CI) & won't censor or interfere with presentation/conclusions except to protect CI (other than Study Data) & its rights in patentable or copyrightable materials, & check technical accuracy of MDT data.
If told by MDT that Publication contains CI or technical errors of MDT data, PI will make requested changes before publishing/presenting. PI will delay publication up to 90 more days, if requested.
| Title | Measurements |
|---|---|
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| Acute Kidney Injury: Stage 2 or 3 |
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| Coronary Artery Obstruction |
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| Major Vascular Complication |
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| Valve-Related Dysfunction Requiring Repeat Procedure |
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| Mild to Moderate |
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| Moderate |
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| Moderate to Severe |
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| Severe |
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| Paravalvular Aortic Regurgitation |
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| Transvalvular Aortic Regurgitation |
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| Title | Measurements |
|---|---|
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| annular rupture or dissection |
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| ventricular perforation |
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| mitral valve damage |
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| prosthetic valve displacement, migration, or embolism |
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| acute kidney injury |
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| Title | Measurements |
|---|---|
|
| Mild |
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| Mild to Moderate |
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| Moderate |
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| Moderate to Severe |
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| Severe |
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| NYHA IV |
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| Died prior to visit |
|
| Title | Measurements |
|---|
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| NYHA IV |
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| Died prior to visit |
|
| Title | Measurements |
|---|
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| NYHA IV |
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| Died Prior to visit |
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| Title | Measurements |
|---|---|
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| Mild |
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| Mild to Moderate |
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| Moderate |
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| Moderate to Severe |
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| Severe |
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| Title | Measurements |
|---|
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| NYHA IV |
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| Died Prior to visit |
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