Severe, Symptomatic Aortic Stenosis
Conditions
Brief summary
Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve™ Evolut™ 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).
Detailed description
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.
Interventions
DEVICEMedtronic CoreValve™ Evolut™ PRO System
The system comprised of the following three components: 1. CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (TAV) 2. EnVeo™ PRO Delivery Catheter System (DCS) 3. EnVeo™ PRO Loading System (LS)
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aortic valve area (AVA) \< 1.0 cm2 (or indexed AVA \<0.6 cm2/m2) OR mean gradient \> 40 mmHg, OR max aortic velocity \> 4.0 m/sec 2. High risk for SAVR defined as STS-PROM score ≥ 8% AND ≤ 15%, OR documented Heart Team agreement of high risk for AVR due to frailty or comorbidities 3. Symptoms of aortic stenosis and NYHA ≥ II
Exclusion criteria
1. Age is less than 65 years old 2. Non-calcified aortic valve 3. Bicuspid aortic valve with no raphe or 2 raphes (Sievers classification type 0 or type 2) 4. Ascending aortic diameter \> 4.5 cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality | 30 days | All-cause mortality at 30 days |
| Percentage (%) of Subjects With Evaluable Echocardiograms With Moderate or Severe Aortic Regurgitation by Transthoracic Echocardiography (TTE) | 30 days | Percentage (%) of Subjects with evaluable echocardiograms with moderate or severe aortic regurgitation by transthoracic echocardiography (TTE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | 30 days | Degree of aortic regurgitation (transvalvular, paravalvular, total) |
| Incidence of an VARC II Combined Composite | 30 days | Incidence of an VARC II combined composite includes the following components: * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening bleeding * Acute kidney injury: stage 2 or 3 (including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR) |
| Event Rates of the Individual Components of the VARC II Composite | 30 days | Event rate of the individual components listed in the outcome |
| New Permanent Pacemaker Rate | 30 days | New permanent pacemaker rate |
| Device Success Rate | Between 24 hours and 7 days post procedure | Device success rate: * Percentage of participants with absence of procedural mortality, AND * Percentage of participants with correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Percentage of participants with intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity \<3m/sec), AND absence of moderate or severe prosthetic valve regurgitation |
| Valve Performance Parameter - Mean Aortic Gradient | 30 days | Mean aortic gradient |
| Valve Performance Parameter - Effective Orifice Area | 30 days | Effective orifice area |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Prosthetic Valve Thrombosis | 30 days | 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. |
| Valve-related Dysfunction | 1 Year | Incidence of valve-related dysfunction defined as moderate or severe prosthetic valve stenosis, or moderate or severe prosthetic regurgitation (per VARC II) |
| Incidence of Valve-related Dysfunction Requiring Repeat Procedure | 30 days | Incidence of Valve-related dysfunction requiring repeat procedure |
| Valve Hemodynamic Performance Metric - Mean Aortic Gradient | 1 year | Mean aortic gradient |
| Valve Hemodynamic Performance Metric - Effective Orifice Area | 1 year | Effective orifice area |
| Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | 1 year | Degree of aortic regurgitation (transvalvular, paravalvular, total) |
| New York Heart Association (NYHA) Functional Classification | 30 days | 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. |
| EQ-5D Quality of Life | 30 days | 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). |
| Event Rates of TAVI-related Complications | 30 days | Rate of the following TAVI-related complications: 1. change to surgery 2. need for cardiopulmonary mechanical assistance 3. coronary occlusion or obstruction 4. annular rupture or dissection 5. ventricular perforation 6. mitral valve damage 7. prosthetic valve displacement, migration, or embolism 8. acute kidney injury (up to 7 days post procedure) |
| All-cause Mortality | 6 months | Percentage of participants with all-cause mortality |
| All Stroke | 6 months | Incidence of stroke (disabling and non-disabling) |
| Myocardial Infarction | 30 days | Incidence of MI |
| Incidence of Life-threatening Bleeding | 30 days | Incidence of life-threatening bleeding: 1. Fatal bleeding (BARC type 5) OR 2. Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR 3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR 4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units\* (BARC type 3b) |
| New AV-Conduction Disturbances (Left Bundle Branch Block (LBBB) and Right Bundle Branch Block (RBBB)) | 30 days | Incidence of either LBBB or RBBB |
| Incidence of Prosthetic Valve Endocarditis | 30 days | Incidence of prosthetic valve endocarditis: Any one of the following: 1. Fulfillment of the following Duke criteria for definite endocarditis * Histologic and/or microbiologic evidence of infection at surgery or autopsy, or * 2 major criteria, or * 1 major criteria and 3 minor criteria, or * 5 minor criteria 2. Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation 3. Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ 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. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Experimental: Medtronic CoreValve™ Evolut™ PRO System | — |
|---|---|---|
| Age, Continuous | 76.7 years STANDARD_DEVIATION 7.3 | — |
| BSA | 1.6 m^2 STANDARD_DEVIATION 0.2 | — |
| NYHA I | 0 Participants | — |
| NYHA II | 6 Participants | — |
| NYHA III | 26 Participants | — |
| NYHA IV | 18 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment China | 50 participants | — |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
| STS Score | 5.6 % STANDARD_DEVIATION 3.3 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 50 |
| other Total, other adverse events | 39 / 50 |
| serious Total, serious adverse events | 28 / 50 |
Outcome results
Primary
All-cause Mortality
All-cause mortality at 30 days
Time frame: 30 days
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | All-cause Mortality | 0.0 Percent of Participants (K-M Rate) |
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)
Time frame: 30 days
Population: Number of subjects with evaluable aortic regurgitation from echo core lab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Percentage (%) of Subjects With Evaluable Echocardiograms With Moderate or Severe Aortic Regurgitation by Transthoracic Echocardiography (TTE) | 2.2 Percentage (%) of participants |
Secondary
Device Success Rate
Device success rate: * Percentage of participants with absence of procedural mortality, AND * Percentage of participants with correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Percentage of participants with intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity \<3m/sec), AND absence of moderate or severe prosthetic valve regurgitation
Time frame: Between 24 hours and 7 days post procedure
Population: Number of attempted implant subjects with evaluable data for device success
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Device Success Rate | 63.9 Percentage (%) of participants |
Secondary
Event Rates of the Individual Components of the VARC II Composite
Event rate of the individual components listed in the outcome
Time frame: 30 days
Population: Number of attempted implant population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of the Individual Components of the VARC II Composite | All-Cause Mortality | 0.0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of the Individual Components of the VARC II Composite | All Stroke | 0.0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of the Individual Components of the VARC II Composite | Life Threatening or Disabling Bleeding | 0.0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of the Individual Components of the VARC II Composite | Acute Kidney Injury: Stage 2 or 3 | 0.0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of the Individual Components of the VARC II Composite | Coronary Artery Obstruction | 4.0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of the Individual Components of the VARC II Composite | Major Vascular Complication | 0.0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of the Individual Components of the VARC II Composite | Valve-Related Dysfunction Requiring Repeat Procedure | 0.0 Percent of Participants (K-M Rate) |
Secondary
Incidence of an VARC II Combined Composite
Incidence of an VARC II combined composite includes the following components: * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening bleeding * Acute kidney injury: stage 2 or 3 (including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
Time frame: 30 days
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of an VARC II Combined Composite | 4 Percent of Participants (K-M Rate) |
Secondary
New Permanent Pacemaker Rate
New permanent pacemaker rate
Time frame: 30 days
Population: Number of attempted implant population. Subjects with a pacemaker or ICD at baseline are excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New Permanent Pacemaker Rate | 8.8 Percent of Participants (K-M Rate) |
Secondary
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total)
Degree of aortic regurgitation (transvalvular, paravalvular, total)
Time frame: 30 days
Population: Number of implanted subjects with echo core lab evaluable values
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Transvalvular Aortic Regurgitation | Severe | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Total Aortic Regurgitation | None | 18 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Total Aortic Regurgitation | Trace | 15 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Total Aortic Regurgitation | Mild | 9 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Total Aortic Regurgitation | Mild to Moderate | 2 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Total Aortic Regurgitation | Moderate | 1 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Total Aortic Regurgitation | Moderate to Severe | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Total Aortic Regurgitation | Severe | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Paravalvular Aortic Regurgitation | None | 19 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Paravalvular Aortic Regurgitation | Trace | 14 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Paravalvular Aortic Regurgitation | Mild | 9 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Paravalvular Aortic Regurgitation | Mild to Moderate | 2 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Paravalvular Aortic Regurgitation | Moderate | 1 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Paravalvular Aortic Regurgitation | Moderate to Severe | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Paravalvular Aortic Regurgitation | Severe | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Transvalvular Aortic Regurgitation | None | 43 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Transvalvular Aortic Regurgitation | Trace | 2 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Transvalvular Aortic Regurgitation | Mild | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Transvalvular Aortic Regurgitation | Mild to Moderate | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Transvalvular Aortic Regurgitation | Moderate | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Transvalvular Aortic Regurgitation | Moderate to Severe | 0 Participants |
Secondary
Valve Performance Parameter - Effective Orifice Area
Effective orifice area
Time frame: 30 days
Population: Number of implanted subjects with echo core lab evaluable values
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter - Effective Orifice Area | 1.8 cm^2 | Standard Deviation 0.4 |
Secondary
Valve Performance Parameter - Mean Aortic Gradient
Mean aortic gradient
Time frame: 30 days
Population: Number of implanted subjects with echo core lab evaluable values
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Performance Parameter - Mean Aortic Gradient | 10.7 mmHg | Standard Deviation 4.9 |
Other Pre-specified
All-cause Mortality
Percentage of participants with all-cause mortality
Time frame: 1 year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | All-cause Mortality | 8.2 Percent of Participants (K-M Rate) |
Other Pre-specified
All-cause Mortality
Percentage of participants with all-cause mortality
Time frame: 6 months
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | All-cause Mortality | 2.0 Percent of Participants (K-M Rate) |
Other Pre-specified
All-cause Mortality
Percentage of participants with all-cause mortality
Time frame: 2 year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | All-cause Mortality | 10.3 Percent of Participants (K-M Rate) |
Other Pre-specified
All Stroke
Incidence of stroke (disabling and non-disabling)
Time frame: 6 months
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | All Stroke | 2.0 Percent of Participants (K-M Rate) |
Other Pre-specified
All Stroke
Incidence of stroke (disabling and non-disabling)
Time frame: 1 year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | All Stroke | 4.1 Percent of Participants (K-M Rate) |
Other Pre-specified
All Stroke
Incidence of stroke (disabling and non-disabling)
Time frame: 2 year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | All Stroke | 6.4 Percent of Participants (K-M Rate) |
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).
Time frame: 1 Year
Population: Number of attempted subjects with available EQ5D
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | EQ-5D Quality of Life | EQ-5D Index Score | 0.905 Score on a scale | Standard Deviation 0.093 |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | EQ-5D Quality of Life | EQ-5D VAS Score | 79.8 Score on a scale | Standard Deviation 10.4 |
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).
Time frame: 30 days
Population: Number of attempted subjects with available EQ5D
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | EQ-5D Quality of Life | EQ-5D Index Score | 0.880 Score on a scale | Standard Deviation 0.095 |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | EQ-5D Quality of Life | EQ-5D VAS Score | 79.1 Score on a scale | Standard Deviation 14.7 |
Other Pre-specified
Event Rates of TAVI-related Complications
Rate of the following TAVI-related complications: 1. change to surgery 2. need for cardiopulmonary mechanical assistance 3. coronary occlusion or obstruction 4. annular rupture or dissection 5. ventricular perforation 6. mitral valve damage 7. prosthetic valve displacement, migration, or embolism 8. acute kidney injury (up to 7 days post procedure)
Time frame: 30 days
Population: Number of attempted implant population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of TAVI-related Complications | change to surgery | 0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of TAVI-related Complications | need for cardiopulmonary mechanical assistance | 0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of TAVI-related Complications | coronary occlusion or obstruction | 4.0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of TAVI-related Complications | annular rupture or dissection | 0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of TAVI-related Complications | ventricular perforation | 0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of TAVI-related Complications | mitral valve damage | 0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of TAVI-related Complications | prosthetic valve displacement, migration, or embolism | 2.0 Percent of Participants (K-M Rate) |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Event Rates of TAVI-related Complications | acute kidney injury | 0 Percent of Participants (K-M Rate) |
Other Pre-specified
Incidence of Life-threatening Bleeding
Incidence of life-threatening bleeding: 1. Fatal bleeding (BARC type 5) OR 2. Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR 3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR 4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units\* (BARC type 3b)
Time frame: 30 days
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Life-threatening Bleeding | 0 Percent of Participants (K-M Rate) |
Other Pre-specified
Incidence of Life-threatening Bleeding
Incidence of life-threatening bleeding: 1. Fatal bleeding (BARC type 5) OR 2. Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR 3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR 4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units\* (BARC type 3b)
Time frame: 1 Year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Life-threatening Bleeding | 0 Percent of Participants (K-M Rate) |
Other Pre-specified
Incidence of Life-threatening Bleeding
Incidence of life-threatening bleeding: 1. Fatal bleeding (BARC type 5) OR 2. Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR 3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR 4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units\* (BARC type 3b)
Time frame: 2 Year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Life-threatening Bleeding | 0.0 Percent of Participants (K-M Rate) |
Other Pre-specified
Incidence of Life-threatening Bleeding
Incidence of life-threatening bleeding: 1. Fatal bleeding (BARC type 5) OR 2. Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR 3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR 4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units\* (BARC type 3b)
Time frame: 6 months
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Life-threatening Bleeding | 0 Percent of Participants (K-M Rate) |
Other Pre-specified
Incidence of Prosthetic Valve Endocarditis
Incidence of prosthetic valve endocarditis: Any one of the following: 1. Fulfillment of the following Duke criteria for definite endocarditis * Histologic and/or microbiologic evidence of infection at surgery or autopsy, or * 2 major criteria, or * 1 major criteria and 3 minor criteria, or * 5 minor criteria 2. Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation 3. Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy
Time frame: 6 months
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Prosthetic Valve Endocarditis | 0 Percent of Participants (K-M Rate) |
Other Pre-specified
Incidence of Prosthetic Valve Endocarditis
Incidence of prosthetic valve endocarditis: Any one of the following: 1. Fulfillment of the following Duke criteria for definite endocarditis * Histologic and/or microbiologic evidence of infection at surgery or autopsy, or * 2 major criteria, or * 1 major criteria and 3 minor criteria, or * 5 minor criteria 2. Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation 3. Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy
Time frame: 2 Year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Prosthetic Valve Endocarditis | 2.3 Percent of Participants (K-M Rate) |
Other Pre-specified
Incidence of Prosthetic Valve Endocarditis
Incidence of prosthetic valve endocarditis: Any one of the following: 1. Fulfillment of the following Duke criteria for definite endocarditis * Histologic and/or microbiologic evidence of infection at surgery or autopsy, or * 2 major criteria, or * 1 major criteria and 3 minor criteria, or * 5 minor criteria 2. Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation 3. Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy
Time frame: 1 Year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Prosthetic Valve Endocarditis | 0 Percent of Participants (K-M Rate) |
Other Pre-specified
Incidence of Prosthetic Valve Endocarditis
Incidence of prosthetic valve endocarditis: Any one of the following: 1. Fulfillment of the following Duke criteria for definite endocarditis * Histologic and/or microbiologic evidence of infection at surgery or autopsy, or * 2 major criteria, or * 1 major criteria and 3 minor criteria, or * 5 minor criteria 2. Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation 3. Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy
Time frame: 30 days
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Prosthetic Valve Endocarditis | 0 Percent of Participants (K-M Rate) |
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.
Time frame: 1 Year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Prosthetic Valve Thrombosis | 0 Percent of Participants (K-M Rate) |
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.
Time frame: 30 days
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Prosthetic Valve Thrombosis | 0 Percent of Participants (K-M Rate) |
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.
Time frame: 6 months
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Prosthetic Valve Thrombosis | 0 Percent of Participants (K-M Rate) |
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.
Time frame: 2 Year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Prosthetic Valve Thrombosis | 0.0 Percent of Participants (K-M Rate) |
Other Pre-specified
Incidence of Valve-related Dysfunction Requiring Repeat Procedure
Incidence of Valve-related dysfunction requiring repeat procedure
Time frame: 6 months
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Valve-related Dysfunction Requiring Repeat Procedure | 0 Percent of Participants (K-M Rate) |
Other Pre-specified
Incidence of Valve-related Dysfunction Requiring Repeat Procedure
Incidence of Valve-related dysfunction requiring repeat procedure
Time frame: 1 Year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Valve-related Dysfunction Requiring Repeat Procedure | 0 Percent of Participants (K-M Rate) |
Other Pre-specified
Incidence of Valve-related Dysfunction Requiring Repeat Procedure
Incidence of Valve-related dysfunction requiring repeat procedure
Time frame: 30 days
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Valve-related Dysfunction Requiring Repeat Procedure | 0 Percent of Participants (K-M Rate) |
Other Pre-specified
Incidence of Valve-related Dysfunction Requiring Repeat Procedure
Incidence of Valve-related dysfunction requiring repeat procedure
Time frame: 2 Year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Incidence of Valve-related Dysfunction Requiring Repeat Procedure | 0.0 Percent of Participants (K-M Rate) |
Other Pre-specified
Myocardial Infarction
Incidence of MI
Time frame: 2 Year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Myocardial Infarction | 4.1 Percent of Participants (K-M Rate) |
Other Pre-specified
Myocardial Infarction
Incidence of MI
Time frame: 30 days
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Myocardial Infarction | 2.0 Percent of Participants (K-M Rate) |
Other Pre-specified
Myocardial Infarction
Incidence of MI
Time frame: 1 Year
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Myocardial Infarction | 4.1 Percent of Participants (K-M Rate) |
Other Pre-specified
Myocardial Infarction
Incidence of MI
Time frame: 6 months
Population: Number of attempted implant population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Myocardial Infarction | 2.0 Percent of Participants (K-M Rate) |
Other Pre-specified
New AV-Conduction Disturbances (Left Bundle Branch Block (LBBB) and Right Bundle Branch Block (RBBB))
Incidence of either LBBB or RBBB
Time frame: 30 days
Population: Number of attempted implant population. Subjects with LBBB or RBBB at baseline are excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New AV-Conduction Disturbances (Left Bundle Branch Block (LBBB) and Right Bundle Branch Block (RBBB)) | 5 Participants |
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.
Time frame: 6 month
Population: Number of attempted subjects with available NYHA
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA I | 27 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA II | 17 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA III | 2 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA IV | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | Died prior to visit | 1 Participants |
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.
Time frame: 30 days
Population: Number of attempted subjects with available NYHA
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA I | 13 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA II | 27 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA III | 5 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA IV | 1 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | Died prior to visit | 0 Participants |
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.
Time frame: 2 Year
Population: Number of attempted subjects with available NYHA
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA I | 7 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA II | 24 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA III | 5 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA IV | 0.0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | Died Prior to visit | 5 Participants |
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.
Time frame: 1 Year
Population: Number of attempted subjects with available NYHA
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA I | 12 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA II | 19 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA III | 4 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | NYHA IV | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | New York Heart Association (NYHA) Functional Classification | Died Prior to visit | 4 Participants |
Other Pre-specified
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total)
Degree of aortic regurgitation (transvalvular, paravalvular, total)
Time frame: 2 year
Population: Number of implanted subjects with site reported echo evaluable data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Trace | 7 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Moderate | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Mild to Moderate | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | None | 11 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Severe | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Moderate to Severe | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Mild | 8 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Mild to Moderate | 0 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | None | 12 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Trace | 7 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Mild | 7 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Moderate | 0 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Moderate to Severe | 0 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Severe | 0 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Moderate | 0 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Trace | 3 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Severe | 0 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Moderate to Severe | 0 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Mild to Moderate | 0 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Mild | 2 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | None | 21 Participants |
Other Pre-specified
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total)
Degree of aortic regurgitation (transvalvular, paravalvular, total)
Time frame: 1 year
Population: Number of implanted subjects with site reported echo evaluable data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Trace | 8 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Moderate | 1 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Mild to Moderate | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | None | 17 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Severe | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Moderate to Severe | 0 Participants |
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Mild | 8 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Mild to Moderate | 0 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | None | 18 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Trace | 7 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Mild | 8 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Moderate | 1 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Moderate to Severe | 0 Participants |
| Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Severe | 0 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Moderate | 0 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Trace | 1 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Severe | 0 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Moderate to Severe | 0 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Mild to Moderate | 0 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | Mild | 1 Participants |
| Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) | None | 32 Participants |
Other Pre-specified
Valve Hemodynamic Performance Metric - Effective Orifice Area
Effective orifice area
Time frame: 2 year
Population: Number of implanted subjects with site reported echo evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Effective Orifice Area | 1.73 cm^2 | Standard Deviation 0.47 |
Other Pre-specified
Valve Hemodynamic Performance Metric - Effective Orifice Area
Effective orifice area
Time frame: 1 year
Population: Number of implanted subjects with site reported echo evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Effective Orifice Area | 1.68 cm^2 | Standard Deviation 0.52 |
Other Pre-specified
Valve Hemodynamic Performance Metric - Mean Aortic Gradient
Mean aortic gradient
Time frame: 1 year
Population: Number of implanted subjects with site reported echo evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Mean Aortic Gradient | 10.1 mmHg | Standard Deviation 4.5 |
Other Pre-specified
Valve Hemodynamic Performance Metric - Mean Aortic Gradient
Mean aortic gradient
Time frame: 2 year
Population: Number of implanted subjects with site reported echo evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve Hemodynamic Performance Metric - Mean Aortic Gradient | 9.8 mmHg | Standard Deviation 5 |
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)
Time frame: 1 Year
Population: Number of implanted subjects with evaluable site-reported echo data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve-related Dysfunction | 1 Participants |
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)
Time frame: 2 Year
Population: Number of implanted subjects with evaluable site-reported echo data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Medtronic CoreValve™ Evolut™ PRO System | Valve-related Dysfunction | 0.0 Participants |