Aortic Valve Disease, Aortic Stenosis
Conditions
Keywords
Aortic Valve Replacement, Aortic Stenosis, EDWARDS INTUITY
Brief summary
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
Detailed description
This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 6 undergoing elective surgical aortic valve replacement surgery with concomitant coronary bypass grafts. Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and finally to explore additional healthcare resource utilization or health economic endpoints.
Interventions
DEVICEEDWARDS INTUITY
To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR & CABG.
In comparison to control valves available on the market.
Sponsors
Edwards Lifesciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * ≥18 years of age * aortic stenosis / mixed aortic stenosis and aortic insufficiency * SAVR+CABG (1-4 distal anastomoses) * Log. EuroSCORE ≥6 * NYHA Class ≥II Exclusion (i.a.): * pure aortic insufficiency * pre-existing prosthetic heart valve or ring * congenital true bicuspid / unicuspid aortic valve * LVEF \<20%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Subject Time Spent on Cardiopulmonary Cross Clamp | At time of surgery, an average of 1.5 hours | Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level. |
| Average Amount of Time Subject Spent on Cardiopulmonary Bypass | At time of surgery, an average of 2 hours | Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Average Peak Gradients (mmHg) Measurements Over Time. | 30 days, 3 months, 6 months, 1 year, 2 year | Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. |
| Subject's Effective Orifice Area (EOA) Measurement Over Time. | 30 days, 3 months, 6 months, 1 year, 2 year | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. |
| Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. | 30 days, 3 months, 6 months, 1 year, 2 year | Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. |
| Amount of Aortic Valvular Regurgitation Over Time. | 30 days, 3 months, 6 months, 1 year, 2 year | Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. |
| Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery. | Prior to Surgery | Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery. |
| Subjects Who Required a Thoracic Resternotomy Over Time | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points. |
| Subjects Who Received a Permanent Pacemaker Over Time. | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Number of Subjects who received a Permanent Pacemaker shown over various time points. |
| Subjects With a Major Paravalvular Leak (OPC) Over Time | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Number of subjects who experienced a Major Paravalvular Leak (OPC) shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. A major paravalvular leak (OPC)are any events of leak that required surgical intervention or were considered an serious adverse event. |
| Subjects Who Experienced Major Bleeding Over Time. | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Number of subjects who experienced Major Bleeding shown over various time points. |
| Subjects Who Experienced Respiratory Failure Over Time | 30 days, 3 Months , 6 Months, 1 Year, 2 Years. | Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood. |
| Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points. |
| Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. | Baseline and 2 Years | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. |
| Subjects With Endocarditis Over Time | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves. |
| Subjects With a Deep Sternal Would Infection Over Time | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points. |
| Subjects With a Myocardial Infarction Over Time | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle. |
| Subjects With a Thromboembolism Over Time | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation. |
| Subjects With a Cardiac Tamponade Over Time | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart. |
| Subjects With a Cardiac Reoperation for Any Reason Over Time | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points. |
| Subjects Who Died Intraoperatively | Surgery | Number of subjects who died during surgery. |
| Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. |
| Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS). The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status. Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12. |
| Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at baseline, 30 days, 3 Months, 6 Months, 1 Year, and 2 Years. |
| Health Care Utilization | Day of surgical procedure through discharge from the hospital, an average of 2 weeks | The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure. |
| Subjects With Renal Failure Over Time | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Number of subjects who experienced Renal (kidney) Failure shown over various time points. |
| Subject's Average Mean Gradients (mmHg) Measurements Over Time. | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. |
Countries
France
Participant flow
Pre-assignment details
All eligible subjects recruited were randomized to each arm/group as 1:1 ratio at start. Amongst randomized arm/group, three of the subjects randomized to the Edwards INTUITY group were converted to the control group and received commercially available surgical aortic heart valves.
Participants by arm
| Arm | Count |
|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve Subject who received an Edwards INTUITY surgical aortic heart valve. | 59 |
| Edwards INTUITY Surgical Aortic Heart Valve Subject who received an Edwards INTUITY surgical aortic heart valve. | 59 |
| Control Group - Commercial Surgical Aortic Heart Valve Subject who received a commercially available surgical aortic heart valve. | 61 |
| Control Group - Commercial Surgical Aortic Heart Valve Subject who received a commercially available surgical aortic heart valve. | 61 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Conversion to Commercial Valve | 3 | 0 |
| Overall Study | Death | 7 | 5 |
| Overall Study | Valve Explant | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve | Total |
|---|---|---|---|
| Age, Continuous | 79.4 years STANDARD_DEVIATION 4.2 | 80.0 years STANDARD_DEVIATION 4.8 | 79.7 years STANDARD_DEVIATION 4.6 |
| Region of Enrollment Europe | 59 Participants | 61 Participants | 120 Participants |
| Sex: Female, Male Female | 24 Participants | 19 Participants | 43 Participants |
| Sex: Female, Male Male | 35 Participants | 42 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 59 | 5 / 61 |
| other Total, other adverse events | 46 / 59 | 43 / 61 |
| serious Total, serious adverse events | 42 / 59 | 38 / 61 |
Outcome results
Primary
Average Amount of Time Subject Spent on Cardiopulmonary Bypass
Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.
Time frame: At time of surgery, an average of 2 hours
Population: The outcome is reported for subjects where data is available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Average Amount of Time Subject Spent on Cardiopulmonary Bypass | 109.0 Minutes |
| Control Group - Commercial Surgical Aortic Heart Valve | Average Amount of Time Subject Spent on Cardiopulmonary Bypass | 107.0 Minutes |
p-value: 0.8377Wilcoxon (Mann-Whitney)
Primary
Average Subject Time Spent on Cardiopulmonary Cross Clamp
Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.
Time frame: At time of surgery, an average of 1.5 hours
Population: The outcome is reported for subjects where data is available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Average Subject Time Spent on Cardiopulmonary Cross Clamp | 77.5 Minutes |
| Control Group - Commercial Surgical Aortic Heart Valve | Average Subject Time Spent on Cardiopulmonary Cross Clamp | 82.0 Minutes |
p-value: 0.366Wilcoxon (Mann-Whitney)
Secondary
Amount of Aortic Valvular Regurgitation Over Time.
Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
Time frame: 30 days, 3 months, 6 months, 1 year, 2 year
Population: The outcome is reported for subjects where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 30 days | +2 Mild | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +4 Severe | 0 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 3 months | +2 Mild | 0 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 1 year | 0 None | 30 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 30 days | +4 Severe | 0 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 1 year | +1 Trivial/Trace | 8 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 3 months | +3 Moderate | 2 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 1 year | +2 Mild | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 30 days | +1 Trivial/Trace | 12 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 1 year | +3 Moderate | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 6 months | 0 None | 27 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 1 year | +4 Severe | 0 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 3 months | 0 None | 30 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 2 year | 0 None | 31 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +1 Trivial/Trace | 9 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 2 year | +1 Trivial/Trace | 8 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 30 days | +3 Moderate | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 2 year | +2 Mild | 0 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 30 days | 0 None | 30 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 2 year | +3 Moderate | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +2 Mild | 4 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 3 months | +1 Trivial/Trace | 11 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +3 Moderate | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 3 months | +4 Severe | 0 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Amount of Aortic Valvular Regurgitation Over Time. | 2 year | +4 Severe | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 2 year | +2 Mild | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 30 days | 0 None | 38 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 30 days | +1 Trivial/Trace | 13 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 30 days | +2 Mild | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 30 days | +3 Moderate | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 30 days | +4 Severe | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 3 months | 0 None | 41 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 3 months | +1 Trivial/Trace | 7 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 3 months | +2 Mild | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 3 months | +4 Severe | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 6 months | 0 None | 39 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +1 Trivial/Trace | 11 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +2 Mild | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +3 Moderate | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +4 Severe | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 1 year | 0 None | 40 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 1 year | +1 Trivial/Trace | 8 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 1 year | +2 Mild | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 1 year | +3 Moderate | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 1 year | +4 Severe | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 2 year | 0 None | 44 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 2 year | +1 Trivial/Trace | 4 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 2 year | +3 Moderate | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 2 year | +4 Severe | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation Over Time. | 3 months | +3 Moderate | 0 Participants |
Secondary
Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery.
Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.
Time frame: Prior to Surgery
Population: Original number of subjects randomized to each arm/group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery. | 3 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery. | 0 Participants |
Secondary
Health Care Utilization
The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure.
Time frame: Day of surgical procedure through discharge from the hospital, an average of 2 weeks
Population: This outcome is reported for subjects where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Health Care Utilization | Length of stay | 12.0 Days | Standard Deviation 7.2 |
| EDWARDS INTUITY Valve System, Model 8300A | Health Care Utilization | ICU Length of stay | 3.9 Days | Standard Deviation 4.2 |
| EDWARDS INTUITY Valve System, Model 8300A | Health Care Utilization | Intermediate care length of stay | 1.2 Days | Standard Deviation 1.9 |
| Control Group - Commercial Surgical Aortic Heart Valve | Health Care Utilization | Length of stay | 10.5 Days | Standard Deviation 5.3 |
| Control Group - Commercial Surgical Aortic Heart Valve | Health Care Utilization | ICU Length of stay | 2.9 Days | Standard Deviation 1.9 |
| Control Group - Commercial Surgical Aortic Heart Valve | Health Care Utilization | Intermediate care length of stay | 1.2 Days | Standard Deviation 1.4 |
Secondary
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
Time frame: Baseline and 2 Years
Population: The outcome is reported for subjects where data is available.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. | Improved | 40 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. | Same | 6 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. | Worsend | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. | Improved | 43 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. | Same | 9 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. | Worsend | 1 Participants |
Secondary
Subject's Average Mean Gradients (mmHg) Measurements Over Time.
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: The outcome is reported for subjects where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Mean Gradients (mmHg) Measurements Over Time. | 3 months | 10.7 mmHg | Standard Deviation 4 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Mean Gradients (mmHg) Measurements Over Time. | 1 year | 11.2 mmHg | Standard Deviation 4.1 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Mean Gradients (mmHg) Measurements Over Time. | 6 months | 11.7 mmHg | Standard Deviation 4.3 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Mean Gradients (mmHg) Measurements Over Time. | 2 year | 10.6 mmHg | Standard Deviation 4.4 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Mean Gradients (mmHg) Measurements Over Time. | 30 days | 10.6 mmHg | Standard Deviation 3.9 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Mean Gradients (mmHg) Measurements Over Time. | 2 year | 11.3 mmHg | Standard Deviation 4.7 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Mean Gradients (mmHg) Measurements Over Time. | 30 days | 10.1 mmHg | Standard Deviation 3.6 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Mean Gradients (mmHg) Measurements Over Time. | 3 months | 11.1 mmHg | Standard Deviation 3.9 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Mean Gradients (mmHg) Measurements Over Time. | 6 months | 11.4 mmHg | Standard Deviation 4.7 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Mean Gradients (mmHg) Measurements Over Time. | 1 year | 11.5 mmHg | Standard Deviation 4.4 |
Secondary
Subject's Average Peak Gradients (mmHg) Measurements Over Time.
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
Time frame: 30 days, 3 months, 6 months, 1 year, 2 year
Population: The outcome is reported for subjects where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Peak Gradients (mmHg) Measurements Over Time. | 3 months | 19.5 mmHg | Standard Deviation 7 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Peak Gradients (mmHg) Measurements Over Time. | 1 year | 20.0 mmHg | Standard Deviation 7.6 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Peak Gradients (mmHg) Measurements Over Time. | 6 months | 21.1 mmHg | Standard Deviation 7.2 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Peak Gradients (mmHg) Measurements Over Time. | 2 year | 19.5 mmHg | Standard Deviation 7.8 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Peak Gradients (mmHg) Measurements Over Time. | 30 days | 19.8 mmHg | Standard Deviation 7.5 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Peak Gradients (mmHg) Measurements Over Time. | 2 year | 20.4 mmHg | Standard Deviation 8.5 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Peak Gradients (mmHg) Measurements Over Time. | 30 days | 18.4 mmHg | Standard Deviation 6.1 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Peak Gradients (mmHg) Measurements Over Time. | 3 months | 20.2 mmHg | Standard Deviation 7.3 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Peak Gradients (mmHg) Measurements Over Time. | 6 months | 20.6 mmHg | Standard Deviation 8.2 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Peak Gradients (mmHg) Measurements Over Time. | 1 year | 20.6 mmHg | Standard Deviation 7.7 |
Secondary
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Time frame: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | 2 year | 0.864 Units on a scale | Standard Deviation 0.16 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | Baseline | 0.773 Units on a scale | Standard Deviation 0.155 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | 30 day | 0.790 Units on a scale | Standard Deviation 0.18 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | 3 month | 0.850 Units on a scale | Standard Deviation 0.179 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | 6 month | 0.877 Units on a scale | Standard Deviation 0.136 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | 1 year | 0.831 Units on a scale | Standard Deviation 0.172 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | 6 month | 0.827 Units on a scale | Standard Deviation 0.206 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | 2 year | 0.835 Units on a scale | Standard Deviation 0.198 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | 3 month | 0.808 Units on a scale | Standard Deviation 0.2 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | Baseline | 0.723 Units on a scale | Standard Deviation 0.186 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | 1 year | 0.803 Units on a scale | Standard Deviation 0.212 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | 30 day | 0.771 Units on a scale | Standard Deviation 0.189 |
Secondary
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at baseline, 30 days, 3 Months, 6 Months, 1 Year, and 2 Years.
Time frame: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | Baseline | 64.50 Units on a scale | Standard Deviation 21.95 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | 30 day | 71.44 Units on a scale | Standard Deviation 22.69 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | 3 month | 83.20 Units on a scale | Standard Deviation 16.26 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | 6 month | 85.05 Units on a scale | Standard Deviation 15.71 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | 1 year | 82.81 Units on a scale | Standard Deviation 14.86 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | 2 year | 83.12 Units on a scale | Standard Deviation 18.62 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | 1 year | 80.26 Units on a scale | Standard Deviation 21.28 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | Baseline | 57.50 Units on a scale | Standard Deviation 20.98 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | 6 month | 78.74 Units on a scale | Standard Deviation 21.33 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | 30 day | 69.24 Units on a scale | Standard Deviation 21.83 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | 2 year | 79.31 Units on a scale | Standard Deviation 20.33 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | 3 month | 78.26 Units on a scale | Standard Deviation 20.2 |
Secondary
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS). The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status. Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12.
Time frame: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | PCS -6 month | 45.87 Units on a scale | Standard Deviation 6.96 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | MCS -Baseline | 47.30 Units on a scale | Standard Deviation 10.49 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | MCS -30 day | 48.01 Units on a scale | Standard Deviation 10.63 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | PCS -3 month | 44.17 Units on a scale | Standard Deviation 8.77 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | MCS -3 month | 49.56 Units on a scale | Standard Deviation 10.03 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | PCS -1 year | 45.40 Units on a scale | Standard Deviation 8.09 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | MCS -6 month | 50.64 Units on a scale | Standard Deviation 9.71 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | PCS -Baseline | 40.67 Units on a scale | Standard Deviation 7.83 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | MCS -1 year | 51.08 Units on a scale | Standard Deviation 9.38 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | PCS -2 year | 44.74 Units on a scale | Standard Deviation 7.92 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | MCS -2 year | 51.65 Units on a scale | Standard Deviation 9.97 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | PCS -30 day | 40.57 Units on a scale | Standard Deviation 7.88 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | MCS -2 year | 50.62 Units on a scale | Standard Deviation 9.64 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | MCS -Baseline | 44.91 Units on a scale | Standard Deviation 11.16 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | PCS -Baseline | 39.47 Units on a scale | Standard Deviation 7.25 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | PCS -30 day | 41.16 Units on a scale | Standard Deviation 7.02 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | PCS -3 month | 43.73 Units on a scale | Standard Deviation 8.61 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | PCS -6 month | 46.00 Units on a scale | Standard Deviation 8.47 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | PCS -1 year | 46.01 Units on a scale | Standard Deviation 8.52 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | PCS -2 year | 44.02 Units on a scale | Standard Deviation 8.35 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | MCS -30 day | 44.85 Units on a scale | Standard Deviation 11.92 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | MCS -3 month | 48.93 Units on a scale | Standard Deviation 9.46 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | MCS -6 month | 48.45 Units on a scale | Standard Deviation 10.1 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | MCS -1 year | 49.52 Units on a scale | Standard Deviation 10.09 |
Secondary
Subject's Effective Orifice Area (EOA) Measurement Over Time.
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Time frame: 30 days, 3 months, 6 months, 1 year, 2 year
Population: The outcome is reported for subjects where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Effective Orifice Area (EOA) Measurement Over Time. | 3 months | 1.8 centimeters squared | Standard Deviation 0.6 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Effective Orifice Area (EOA) Measurement Over Time. | 1 year | 1.7 centimeters squared | Standard Deviation 0.4 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Effective Orifice Area (EOA) Measurement Over Time. | 6 months | 1.7 centimeters squared | Standard Deviation 0.5 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Effective Orifice Area (EOA) Measurement Over Time. | 2 year | 1.7 centimeters squared | Standard Deviation 0.5 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Effective Orifice Area (EOA) Measurement Over Time. | 30 days | 1.7 centimeters squared | Standard Deviation 0.5 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time. | 2 year | 1.5 centimeters squared | Standard Deviation 0.4 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time. | 30 days | 1.6 centimeters squared | Standard Deviation 0.4 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time. | 3 months | 1.6 centimeters squared | Standard Deviation 0.3 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time. | 6 months | 1.6 centimeters squared | Standard Deviation 0.4 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time. | 1 year | 1.5 centimeters squared | Standard Deviation 0.4 |
Secondary
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
Time frame: 30 days, 3 months, 6 months, 1 year, 2 year
Population: The outcome is reported for subjects where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. | 2 year | 0.9 centimeters squared/meters squared | Standard Deviation 0.3 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. | 3 months | 1.0 centimeters squared/meters squared | Standard Deviation 0.3 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. | 30 days | 1.0 centimeters squared/meters squared | Standard Deviation 0.3 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. | 6 months | 0.9 centimeters squared/meters squared | Standard Deviation 0.3 |
| EDWARDS INTUITY Valve System, Model 8300A | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. | 1 year | 0.9 centimeters squared/meters squared | Standard Deviation 0.2 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. | 6 months | 0.9 centimeters squared/meters squared | Standard Deviation 0.2 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. | 1 year | 0.8 centimeters squared/meters squared | Standard Deviation 0.2 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. | 2 year | 0.8 centimeters squared/meters squared | Standard Deviation 0.2 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. | 30 days | 0.9 centimeters squared/meters squared | Standard Deviation 0.2 |
| Control Group - Commercial Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. | 3 months | 0.9 centimeters squared/meters squared | Standard Deviation 0.2 |
Secondary
Subjects Who Died Intraoperatively
Number of subjects who died during surgery.
Time frame: Surgery
Population: Number of subjects who died during surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Died Intraoperatively | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Died Intraoperatively | 0 Participants |
Secondary
Subjects Who Experienced Major Bleeding Over Time.
Number of subjects who experienced Major Bleeding shown over various time points.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Experienced Major Bleeding Over Time. | 1 year | 15 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Experienced Major Bleeding Over Time. | 30 days | 12 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Experienced Major Bleeding Over Time. | 3 months | 13 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Experienced Major Bleeding Over Time. | 6 months | 15 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Experienced Major Bleeding Over Time. | 2 year | 15 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Experienced Major Bleeding Over Time. | 2 year | 19 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Experienced Major Bleeding Over Time. | 6 months | 17 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Experienced Major Bleeding Over Time. | 30 days | 16 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Experienced Major Bleeding Over Time. | 1 year | 18 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Experienced Major Bleeding Over Time. | 3 months | 17 Participants |
Secondary
Subjects Who Experienced Respiratory Failure Over Time
Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood.
Time frame: 30 days, 3 Months , 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Experienced Respiratory Failure Over Time | 3 months | 3 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Experienced Respiratory Failure Over Time | 1 year | 3 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Experienced Respiratory Failure Over Time | 6 months | 3 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Experienced Respiratory Failure Over Time | 2 year | 3 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Experienced Respiratory Failure Over Time | 30 days | 3 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Experienced Respiratory Failure Over Time | 2 year | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Experienced Respiratory Failure Over Time | 30 days | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Experienced Respiratory Failure Over Time | 3 months | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Experienced Respiratory Failure Over Time | 6 months | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Experienced Respiratory Failure Over Time | 1 year | 1 Participants |
Secondary
Subjects Who Received a Permanent Pacemaker Over Time.
Number of Subjects who received a Permanent Pacemaker shown over various time points.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Received a Permanent Pacemaker Over Time. | 3 months | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Received a Permanent Pacemaker Over Time. | 1 year | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Received a Permanent Pacemaker Over Time. | 6 months | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Received a Permanent Pacemaker Over Time. | 2 year | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Received a Permanent Pacemaker Over Time. | 30 days | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Received a Permanent Pacemaker Over Time. | 2 year | 6 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Received a Permanent Pacemaker Over Time. | 30 days | 4 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Received a Permanent Pacemaker Over Time. | 3 months | 5 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Received a Permanent Pacemaker Over Time. | 6 months | 6 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Received a Permanent Pacemaker Over Time. | 1 year | 6 Participants |
Secondary
Subjects Who Required a Thoracic Resternotomy Over Time
Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Required a Thoracic Resternotomy Over Time | 3 months | 6 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Required a Thoracic Resternotomy Over Time | 1 year | 7 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Required a Thoracic Resternotomy Over Time | 6 months | 6 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Required a Thoracic Resternotomy Over Time | 2 year | 7 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects Who Required a Thoracic Resternotomy Over Time | 30 days | 6 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Required a Thoracic Resternotomy Over Time | 2 year | 8 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Required a Thoracic Resternotomy Over Time | 30 days | 8 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Required a Thoracic Resternotomy Over Time | 3 months | 8 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Required a Thoracic Resternotomy Over Time | 6 months | 8 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects Who Required a Thoracic Resternotomy Over Time | 1 year | 8 Participants |
Secondary
Subjects With a Cardiac Reoperation for Any Reason Over Time
Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cardiac Reoperation for Any Reason Over Time | 3 months | 6 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cardiac Reoperation for Any Reason Over Time | 1 year | 10 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cardiac Reoperation for Any Reason Over Time | 6 months | 9 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cardiac Reoperation for Any Reason Over Time | 2 year | 10 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cardiac Reoperation for Any Reason Over Time | 30 days | 6 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cardiac Reoperation for Any Reason Over Time | 2 year | 13 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cardiac Reoperation for Any Reason Over Time | 30 days | 9 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cardiac Reoperation for Any Reason Over Time | 3 months | 11 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cardiac Reoperation for Any Reason Over Time | 6 months | 12 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cardiac Reoperation for Any Reason Over Time | 1 year | 12 Participants |
Secondary
Subjects With a Cardiac Tamponade Over Time
Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cardiac Tamponade Over Time | 3 months | 3 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cardiac Tamponade Over Time | 1 year | 3 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cardiac Tamponade Over Time | 6 months | 3 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cardiac Tamponade Over Time | 2 year | 3 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cardiac Tamponade Over Time | 30 days | 3 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cardiac Tamponade Over Time | 2 year | 2 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cardiac Tamponade Over Time | 30 days | 2 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cardiac Tamponade Over Time | 3 months | 2 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cardiac Tamponade Over Time | 6 months | 2 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cardiac Tamponade Over Time | 1 year | 2 Participants |
Secondary
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | 3 months | 0 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | 1 year | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | 6 months | 0 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | 2 year | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | 30 days | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | 2 year | 2 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | 30 days | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | 3 months | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | 6 months | 2 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | 1 year | 2 Participants |
Secondary
Subjects With a Deep Sternal Would Infection Over Time
Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Deep Sternal Would Infection Over Time | 3 months | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Deep Sternal Would Infection Over Time | 1 year | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Deep Sternal Would Infection Over Time | 6 months | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Deep Sternal Would Infection Over Time | 2 year | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Deep Sternal Would Infection Over Time | 30 days | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Deep Sternal Would Infection Over Time | 2 year | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Deep Sternal Would Infection Over Time | 30 days | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Deep Sternal Would Infection Over Time | 3 months | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Deep Sternal Would Infection Over Time | 6 months | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Deep Sternal Would Infection Over Time | 1 year | 0 Participants |
Secondary
Subjects With a Major Paravalvular Leak (OPC) Over Time
Number of subjects who experienced a Major Paravalvular Leak (OPC) shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. A major paravalvular leak (OPC)are any events of leak that required surgical intervention or were considered an serious adverse event.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Major Paravalvular Leak (OPC) Over Time | 3 months | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Major Paravalvular Leak (OPC) Over Time | 1 year | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Major Paravalvular Leak (OPC) Over Time | 6 months | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Major Paravalvular Leak (OPC) Over Time | 2 year | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Major Paravalvular Leak (OPC) Over Time | 30 days | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Major Paravalvular Leak (OPC) Over Time | 2 year | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Major Paravalvular Leak (OPC) Over Time | 30 days | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Major Paravalvular Leak (OPC) Over Time | 3 months | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Major Paravalvular Leak (OPC) Over Time | 6 months | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Major Paravalvular Leak (OPC) Over Time | 1 year | 0 Participants |
Secondary
Subjects With a Myocardial Infarction Over Time
Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Myocardial Infarction Over Time | 3 months | 2 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Myocardial Infarction Over Time | 1 year | 3 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Myocardial Infarction Over Time | 6 months | 3 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Myocardial Infarction Over Time | 2 year | 3 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Myocardial Infarction Over Time | 30 days | 2 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Myocardial Infarction Over Time | 2 year | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Myocardial Infarction Over Time | 30 days | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Myocardial Infarction Over Time | 3 months | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Myocardial Infarction Over Time | 6 months | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Myocardial Infarction Over Time | 1 year | 1 Participants |
Secondary
Subjects With a Thromboembolism Over Time
Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Thromboembolism Over Time | 3 months | 2 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Thromboembolism Over Time | 1 year | 4 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Thromboembolism Over Time | 6 months | 3 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Thromboembolism Over Time | 2 year | 5 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With a Thromboembolism Over Time | 30 days | 2 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Thromboembolism Over Time | 2 year | 4 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Thromboembolism Over Time | 30 days | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Thromboembolism Over Time | 3 months | 2 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Thromboembolism Over Time | 6 months | 3 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With a Thromboembolism Over Time | 1 year | 4 Participants |
Secondary
Subjects With Endocarditis Over Time
Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With Endocarditis Over Time | 3 months | 0 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With Endocarditis Over Time | 1 year | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With Endocarditis Over Time | 6 months | 0 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With Endocarditis Over Time | 2 year | 1 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With Endocarditis Over Time | 30 days | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With Endocarditis Over Time | 2 year | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With Endocarditis Over Time | 30 days | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With Endocarditis Over Time | 3 months | 0 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With Endocarditis Over Time | 6 months | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With Endocarditis Over Time | 1 year | 1 Participants |
Secondary
Subjects With Renal Failure Over Time
Number of subjects who experienced Renal (kidney) Failure shown over various time points.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Population: Cumulative number of subjects with an event by each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With Renal Failure Over Time | 3 months | 2 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With Renal Failure Over Time | 1 year | 2 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With Renal Failure Over Time | 6 months | 2 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With Renal Failure Over Time | 2 year | 2 Participants |
| EDWARDS INTUITY Valve System, Model 8300A | Subjects With Renal Failure Over Time | 30 days | 2 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With Renal Failure Over Time | 2 year | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With Renal Failure Over Time | 30 days | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With Renal Failure Over Time | 3 months | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With Renal Failure Over Time | 6 months | 1 Participants |
| Control Group - Commercial Surgical Aortic Heart Valve | Subjects With Renal Failure Over Time | 1 year | 1 Participants |