Aortic Stenosis, Aortic Valve Disease, Rapid Deployment Valves
Conditions
Keywords
Aortic Valve Replacement, Aortic Stenosis, EDWARDS INTUITY
Brief summary
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population. The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.
Detailed description
Aortic valve replacement with mechanical or biological heart valves is the treatment of choice for aortic valve stenosis. Over the past several years, life expectancy has increased in industrial nations, but this has been accompanied by a rising rate of elderly patients with multiple illnesses. Aortic stenosis remains the most common cause of adult valvular heart disease, the prevalence increasing with age. Average survival of patients treated conservatively has historically been reported as 2-5 years from the onset of symptoms. More recent studies have confirmed the dismal prognosis of severe aortic stenosis. Advanced age, reduced left ventricular ejection fraction, congestive heart failure and renal insufficiency appear to be independent predictors of reduced survival. Asymptomatic patients with very severe aortic stenosis also share a poor prognosis with a high event rate and a risk of rapid functional deterioration. Early surgery offers a therapeutic option to improve clinical outcomes via decreasing cardiac mortality and improving symptoms. Bioprostheses offer several advantages over mechanical bioprostheses, the most important being freedom from anticoagulation with a low rate of thromboembolic accidents. In response to clinical need and in support of advances in minimally invasive surgical approaches to conventional AVR, Edwards Lifesciences developed the EDWARDS INTUITY Valve System to achieve clinical benefits by reducing cardiopulmonary bypass and cross clamp times, while facilitating a less invasive approach to aortic valve replacement. The system includes the EDWARDS INTUITY Valve System, Model 8300A and the EDWARDS INTUITY Delivery System, Model 8300D; the valve is based on prior heart valve designs which have a long history of safety and effectiveness and have incorporated additional features designed to improve patient outcomes and safety. With only 3 guiding sutures and secure balloon expandable frame, the EDWARDS INTUITY Valve system is well suited for smaller incisions and tight access, with an emphasis on procedural efficiency within existing operating suite of the surgeon.
Interventions
None listed
Sponsors
Edwards Lifesciences
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is 18 years or older 2. Subject presents with aortic stenosis or stenosis-based insufficiency of an aortic valve requiring a planned replacement of the native aortic valve or previously implanted aortic prosthesis. 3. Subject has signed and dated the investigation informed consent forms prior to study-specific procedures are performed. 4. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.
Exclusion criteria
1. History of active endocarditis within three months of scheduled surgery 2. Subject is diagnosed with pure aortic insufficiency 3. Aneurysm of the aortic root and/or ascending aorta
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Average Time Spent on Cardiopulmonary Cross Clamp | At time of surgery; an average of 1 hour | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject's Average Time Spent on Cardiopulmonary Bypass | At time of surgery; an average of 1.5 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. |
| Subject's Average Skin-to-skin Time | At time of surgery; an average of 3.5 hours | The time from start of skin incision to end of skin closure. |
| Subject's Device Technical Success | At time of surgery | Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with the subject leaving the operating room (OR) with valve in place. |
| Subject's Average Health Care Utilization | Day of surgical procedure through discharge from the ICU and hospital, an average of 3 days and 11 days respectively. | The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure. |
| Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 30 days, 3 months, 1 year, 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. |
| Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | Baseline, 3 months | 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 Mean Gradient Measurements | Baseline, discharge, 3 months, and 1 year | 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. |
| Subject's Average Peak Gradients (mmHg) Measurements Over Time | Baseline, discharge, 3 months, and 1 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 Average Effective Orifice Area Measurements | Baseline, discharge, 3 months, 1 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 Average Performance Index Measurements | Discharge, 3 Months, 1 Year | Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time. |
| Subject's Average Effective Orifice Area Index (EOAI) Measurements | Baseline, Discharge, 3 months, 1 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. |
| Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge, 3 months, 1 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. |
| Subject's Amount of Paravalvular Leak Over Time. | Discharge, 3 months, 1 year | 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 minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome. |
| Subject's Average Cardiac Output Over Time | Discharge, 3 months, 1 year | The amount of blood the heart pumps through the circulatory system in a minute. |
| Subject's Average Cardiac Output Index | Discharge, 3 Months, 1 Year | A hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA). |
| Subject's Average Left Ventricular End-Diastolic Dimension | Baseline, Discharge, 3 Months, 1 Year | The measurement of the heart's left ventricle at end diastole. |
| Subject's Average Left Ventricular End-Systolic Dimension | Baseline, Discharge, 3 Months, 1 Year | The measurement of the heart's left ventricle at end systole. |
| Left Ventricular End-diastolic Volume (LVEDV) | Baseline, Discharge, 3 Months, 1 Year | Left Ventricular end-diastolic volume (LVEDV) is the amount of (volume) of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole. |
| Left Ventricular End-systolic Volume (LVESV) | Baseline, Discharge, 3 Months, 1 Year | Left Ventricular end-systolic volume (LVESV) is the amount of (volume) of blood in the left ventricle at the end of the heart's contraction, or systole, and the beginning of filling, or diastole. |
| Percentage of Subjects With Early Adverse Events | Events occurring within 30 days of procedure | Number of Subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100. |
| Percentage of Late Adverse Events Divided by Late Patient Years | Events occurring >= 31 days and up through 2 years post-implant | Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). |
| Subject's Average Left Ventricular Ejection Fraction (LVEF) | Baseline, discharge, 3 months, 1 year | Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. Ejection fraction is evaluated by echocardiography over time. A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%. |
Countries
Austria, Denmark, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Participant flow
Pre-assignment details
516 Subjects were enrolled in this study, for which data is available.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Cohort Subjects were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon placed the first guiding suture on the bioprosthesis. | 516 |
| Total | 516 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 46 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Missing Exit Reason on Exit Form | 1 |
| Overall Study | Other Reason | 3 |
| Overall Study | Patients Without Exit Form | 47 |
| Overall Study | Valve Explant | 11 |
| Overall Study | Valve Implant Failure | 17 |
| Overall Study | Withdrawal by Subject or by Investigator | 10 |
Baseline characteristics
| Characteristic | Enrolled Cohort |
|---|---|
| Age, Continuous | 75.5 years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 218 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 240 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 456 Participants |
| Sex/Gender, Customized Female | 223 Participants |
| Sex/Gender, Customized Male | 293 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 46 / 516 |
| other Total, other adverse events | 157 / 516 |
| serious Total, serious adverse events | 245 / 516 |
Outcome results
Primary
Subject's Average 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 hour
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Time Spent on Cardiopulmonary Cross Clamp | 59.7 minutes | Standard Deviation 24 |
Other Pre-specified
Left Ventricular End-diastolic Volume (LVEDV)
Left Ventricular end-diastolic volume (LVEDV) is the amount of (volume) of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole.
Time frame: Baseline, Discharge, 3 Months, 1 Year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Left Ventricular End-diastolic Volume (LVEDV) | Baseline | 62.68 milliliters | Standard Deviation 23.55 |
| INTUITY (Study Valve Cohort) | Left Ventricular End-diastolic Volume (LVEDV) | Discharge | 52.90 milliliters | Standard Deviation 20.35 |
| INTUITY (Study Valve Cohort) | Left Ventricular End-diastolic Volume (LVEDV) | 3 Months | 56.96 milliliters | Standard Deviation 24.76 |
| INTUITY (Study Valve Cohort) | Left Ventricular End-diastolic Volume (LVEDV) | 1 Year | 60.86 milliliters | Standard Deviation 21.22 |
| INTUITY (Study Valve Cohort) - 21mm | Left Ventricular End-diastolic Volume (LVEDV) | 3 Months | 64.89 milliliters | Standard Deviation 20.44 |
| INTUITY (Study Valve Cohort) - 21mm | Left Ventricular End-diastolic Volume (LVEDV) | Discharge | 63.26 milliliters | Standard Deviation 24.58 |
| INTUITY (Study Valve Cohort) - 21mm | Left Ventricular End-diastolic Volume (LVEDV) | Baseline | 75.17 milliliters | Standard Deviation 27.76 |
| INTUITY (Study Valve Cohort) - 21mm | Left Ventricular End-diastolic Volume (LVEDV) | 1 Year | 72.46 milliliters | Standard Deviation 22.17 |
| INTUITY (Study Valve Cohort) - 23mm | Left Ventricular End-diastolic Volume (LVEDV) | 1 Year | 79.12 milliliters | Standard Deviation 26.37 |
| INTUITY (Study Valve Cohort) - 23mm | Left Ventricular End-diastolic Volume (LVEDV) | 3 Months | 74.94 milliliters | Standard Deviation 23.96 |
| INTUITY (Study Valve Cohort) - 23mm | Left Ventricular End-diastolic Volume (LVEDV) | Discharge | 70.93 milliliters | Standard Deviation 24.61 |
| INTUITY (Study Valve Cohort) - 23mm | Left Ventricular End-diastolic Volume (LVEDV) | Baseline | 83.52 milliliters | Standard Deviation 31.17 |
| INTUITY (Study Valve Cohort) - 25mm | Left Ventricular End-diastolic Volume (LVEDV) | Baseline | 101.91 milliliters | Standard Deviation 33.55 |
| INTUITY (Study Valve Cohort) - 25mm | Left Ventricular End-diastolic Volume (LVEDV) | 1 Year | 85.80 milliliters | Standard Deviation 27.47 |
| INTUITY (Study Valve Cohort) - 25mm | Left Ventricular End-diastolic Volume (LVEDV) | Discharge | 82.10 milliliters | Standard Deviation 30.54 |
| INTUITY (Study Valve Cohort) - 25mm | Left Ventricular End-diastolic Volume (LVEDV) | 3 Months | 91.66 milliliters | Standard Deviation 32.8 |
| INTUITY (Study Valve Cohort) - 27mm | Left Ventricular End-diastolic Volume (LVEDV) | 3 Months | 93.42 milliliters | Standard Deviation 31.21 |
| INTUITY (Study Valve Cohort) - 27mm | Left Ventricular End-diastolic Volume (LVEDV) | 1 Year | 86.47 milliliters | Standard Deviation 31.99 |
| INTUITY (Study Valve Cohort) - 27mm | Left Ventricular End-diastolic Volume (LVEDV) | Discharge | 102.27 milliliters | Standard Deviation 39.83 |
| INTUITY (Study Valve Cohort) - 27mm | Left Ventricular End-diastolic Volume (LVEDV) | Baseline | 109.90 milliliters | Standard Deviation 41.78 |
| INTUITY (Study Valve Cohort) - Overall | Left Ventricular End-diastolic Volume (LVEDV) | Discharge | 69.74 milliliters | Standard Deviation 28.83 |
| INTUITY (Study Valve Cohort) - Overall | Left Ventricular End-diastolic Volume (LVEDV) | 3 Months | 74.78 milliliters | Standard Deviation 28.67 |
| INTUITY (Study Valve Cohort) - Overall | Left Ventricular End-diastolic Volume (LVEDV) | 1 Year | 76.69 milliliters | Standard Deviation 26.49 |
| INTUITY (Study Valve Cohort) - Overall | Left Ventricular End-diastolic Volume (LVEDV) | Baseline | 83.00 milliliters | Standard Deviation 33.22 |
Other Pre-specified
Left Ventricular End-systolic Volume (LVESV)
Left Ventricular end-systolic volume (LVESV) is the amount of (volume) of blood in the left ventricle at the end of the heart's contraction, or systole, and the beginning of filling, or diastole.
Time frame: Baseline, Discharge, 3 Months, 1 Year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Left Ventricular End-systolic Volume (LVESV) | Baseline | 22 milliliters | Standard Error 13.47 |
| INTUITY (Study Valve Cohort) | Left Ventricular End-systolic Volume (LVESV) | Discharge | 18.57 milliliters | Standard Error 12.38 |
| INTUITY (Study Valve Cohort) | Left Ventricular End-systolic Volume (LVESV) | 3 Months | 20.10 milliliters | Standard Error 10.93 |
| INTUITY (Study Valve Cohort) | Left Ventricular End-systolic Volume (LVESV) | 1 Year | 21.86 milliliters | Standard Error 9.28 |
| INTUITY (Study Valve Cohort) - 21mm | Left Ventricular End-systolic Volume (LVESV) | 3 Months | 22.33 milliliters | Standard Error 13.05 |
| INTUITY (Study Valve Cohort) - 21mm | Left Ventricular End-systolic Volume (LVESV) | Discharge | 23.90 milliliters | Standard Error 15.69 |
| INTUITY (Study Valve Cohort) - 21mm | Left Ventricular End-systolic Volume (LVESV) | Baseline | 27.50 milliliters | Standard Error 18.97 |
| INTUITY (Study Valve Cohort) - 21mm | Left Ventricular End-systolic Volume (LVESV) | 1 Year | 26.62 milliliters | Standard Error 12.57 |
| INTUITY (Study Valve Cohort) - 23mm | Left Ventricular End-systolic Volume (LVESV) | 1 Year | 28.37 milliliters | Standard Error 14.15 |
| INTUITY (Study Valve Cohort) - 23mm | Left Ventricular End-systolic Volume (LVESV) | 3 Months | 26.17 milliliters | Standard Error 14.66 |
| INTUITY (Study Valve Cohort) - 23mm | Left Ventricular End-systolic Volume (LVESV) | Discharge | 24.51 milliliters | Standard Error 13.95 |
| INTUITY (Study Valve Cohort) - 23mm | Left Ventricular End-systolic Volume (LVESV) | Baseline | 30.46 milliliters | Standard Error 19.03 |
| INTUITY (Study Valve Cohort) - 25mm | Left Ventricular End-systolic Volume (LVESV) | Baseline | 42.36 milliliters | Standard Error 26.74 |
| INTUITY (Study Valve Cohort) - 25mm | Left Ventricular End-systolic Volume (LVESV) | 1 Year | 32.00 milliliters | Standard Error 13.02 |
| INTUITY (Study Valve Cohort) - 25mm | Left Ventricular End-systolic Volume (LVESV) | Discharge | 33.27 milliliters | Standard Error 19.96 |
| INTUITY (Study Valve Cohort) - 25mm | Left Ventricular End-systolic Volume (LVESV) | 3 Months | 35.77 milliliters | Standard Error 22.99 |
| INTUITY (Study Valve Cohort) - 27mm | Left Ventricular End-systolic Volume (LVESV) | 3 Months | 35.50 milliliters | Standard Error 19.66 |
| INTUITY (Study Valve Cohort) - 27mm | Left Ventricular End-systolic Volume (LVESV) | 1 Year | 31.68 milliliters | Standard Error 19.08 |
| INTUITY (Study Valve Cohort) - 27mm | Left Ventricular End-systolic Volume (LVESV) | Discharge | 41.36 milliliters | Standard Error 27.97 |
| INTUITY (Study Valve Cohort) - 27mm | Left Ventricular End-systolic Volume (LVESV) | Baseline | 40.76 milliliters | Standard Error 24.75 |
| INTUITY (Study Valve Cohort) - Overall | Left Ventricular End-systolic Volume (LVESV) | Discharge | 25.99 milliliters | Standard Error 17.46 |
| INTUITY (Study Valve Cohort) - Overall | Left Ventricular End-systolic Volume (LVESV) | 3 Months | 27.07 milliliters | Standard Error 17.36 |
| INTUITY (Study Valve Cohort) - Overall | Left Ventricular End-systolic Volume (LVESV) | 1 Year | 27.98 milliliters | Standard Error 13.64 |
| INTUITY (Study Valve Cohort) - Overall | Left Ventricular End-systolic Volume (LVESV) | Baseline | 31.22 milliliters | Standard Error 21.41 |
Other Pre-specified
Percentage of Late Adverse Events Divided by Late Patient Years
Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Time frame: Events occurring >= 31 days and up through 2 years post-implant
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | All cause mortality | 3.6 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | Study valve-related mortality | 1.4 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | Thromboembolic events | 1.6 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | Study valve thrombosis | 0.0 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | Bleeding event | 0.6 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | All Paravalvular Leak | 10.8 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | Major paravalvular leak (Moderate or Severe) | 1.3 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | Endocarditis | 0.6 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | Structural valve deterioration | 0.0 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | Non-structural valve deterioration (other than PVL | 0.0 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | Hemolysis | 0.4 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | Reoperation | 1.1 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | Explant | 0.7 Percentage of events/late patient years |
| INTUITY (Study Valve Cohort) | Percentage of Late Adverse Events Divided by Late Patient Years | New and worsening conduction disturbance | 0.0 Percentage of events/late patient years |
Other Pre-specified
Percentage of Subjects With Early Adverse Events
Number of Subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
Time frame: Events occurring within 30 days of procedure
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | All cause mortality | 3.0 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | Study valve-related mortality | 1.4 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | Thromboembolic events | 3.9 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | Study valve thrombosis | 0.2 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | Bleeding event | 6.3 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | All paravalvular leak | 15.0 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | Major paravalvular leak (Moderate or Severe) | 1.2 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | Endocarditis | 0.0 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | Structural valve deterioration | 0.0 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | Non-structural valve deterioration (other than PVL | 0.0 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | Hemolysis | 0.4 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | Reoperation | 1.2 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | Explant | 0.8 Percentage of subjects |
| INTUITY (Study Valve Cohort) | Percentage of Subjects With Early Adverse Events | New and worsening conduction disturbance | 7.3 Percentage of subjects |
Other Pre-specified
Subject's 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: Discharge, 3 months, 1 year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | 0 None | 34 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +3 Moderate | 1 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +2 Mild | 5 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | 0 None | 29 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +1 Trivial/Trace | 29 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +1 Trivial/Trace | 28 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +1 Trivial/Trace | 15 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | 0 None | 25 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +3 Moderate | 1 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +2 Mild | 5 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +2 Mild | 7 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | 0 None | 69 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +4 Severe | 1 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +3 Moderate | 2 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +1 Trivial/Trace | 39 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +3 Moderate | 1 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +2 Mild | 9 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +3 Moderate | 1 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +2 Mild | 9 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +1 Trivial/Trace | 23 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | 0 None | 67 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +1 Trivial/Trace | 39 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | 0 None | 60 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +2 Mild | 7 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +1 Trivial/Trace | 43 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +3 Moderate | 3 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +3 Moderate | 5 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | 0 None | 80 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +4 Severe | 2 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +2 Mild | 9 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | 0 None | 78 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +1 Trivial/Trace | 42 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +2 Mild | 12 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | 0 None | 83 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +2 Mild | 9 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +1 Trivial/Trace | 21 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | 0 None | 52 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +1 Trivial/Trace | 22 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +2 Mild | 4 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | 0 None | 55 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +1 Trivial/Trace | 24 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +2 Mild | 4 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | 0 None | 49 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +1 Trivial/Trace | 17 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +2 Mild | 3 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | 0 None | 18 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +2 Mild | 1 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | 0 None | 19 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +2 Mild | 1 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +1 Trivial/Trace | 9 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +1 Trivial/Trace | 6 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +1 Trivial/Trace | 8 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | 0 None | 21 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +2 Mild | 1 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +2 Mild | 28 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +1 Trivial/Trace | 144 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | 0 None | 249 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | 0 None | 260 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | 0 None | 236 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +1 Trivial/Trace | 85 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +3 Moderate | 1 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +4 Severe | 1 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +4 Severe | 2 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +2 Mild | 30 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +1 Trivial/Trace | 140 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +3 Moderate | 8 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 3 Months | +2 Mild | 28 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 1 Year | +3 Moderate | 5 Participants |
Other Pre-specified
Subject's Amount of Paravalvular Leak Over Time.
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 minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Time frame: Discharge, 3 months, 1 year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | 0 None | 32 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +1 Trivial/Trace | 5 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +1 Trivial/Trace | 9 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +3 Moderate | 1 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +2 Mild | 3 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +2 Mild | 1 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | Discharge | 0 None | 59 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +1 Trivial/Trace | 4 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +2 Mild | 4 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | 0 None | 52 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +1 Trivial/Trace | 17 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +2 Mild | 1 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | 0 None | 99 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +2 Mild | 2 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | 0 None | 84 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +1 Trivial/Trace | 20 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +1 Trivial/Trace | 18 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | 0 None | 64 Participants |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +2 Mild | 6 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +2 Mild | 6 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | 0 None | 65 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | 0 None | 96 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +3 Moderate | 1 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | 0 None | 105 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +1 Trivial/Trace | 25 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +2 Mild | 12 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +2 Mild | 14 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +1 Trivial/Trace | 22 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +4 Severe | 1 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +1 Trivial/Trace | 16 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +2 Mild | 4 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | 0 None | 69 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +1 Trivial/Trace | 6 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +2 Mild | 4 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | 0 None | 67 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +1 Trivial/Trace | 11 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | 0 None | 56 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +1 Trivial/Trace | 6 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +2 Mild | 3 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +1 Trivial/Trace | 5 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +2 Mild | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | 0 None | 22 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +1 Trivial/Trace | 4 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +2 Mild | 1 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | 0 None | 20 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | 0 None | 22 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +1 Trivial/Trace | 1 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +2 Mild | 1 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +1 Trivial/Trace | 63 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | Discharge | 0 None | 358 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | 0 None | 238 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | 0 None | 324 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +4 Severe | 1 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +1 Trivial/Trace | 53 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +4 Severe | 0 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +2 Mild | 20 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +2 Mild | 16 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +1 Trivial/Trace | 55 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | 1 Year | +3 Moderate | 2 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +3 Moderate | 0 Participants |
| INTUITY (Study Valve Cohort) - Overall | Subject's Amount of Paravalvular Leak Over Time. | 3 Months | +2 Mild | 26 Participants |
Other Pre-specified
Subject's Average Cardiac Output Index
A hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA).
Time frame: Discharge, 3 Months, 1 Year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Cardiac Output Index | 3 Months | 2.40 L/min/m2 | Standard Deviation 0.88 |
| INTUITY (Study Valve Cohort) | Subject's Average Cardiac Output Index | Discharge | 2.45 L/min/m2 | Standard Deviation 0.89 |
| INTUITY (Study Valve Cohort) | Subject's Average Cardiac Output Index | 1 Year | 2.32 L/min/m2 | Standard Deviation 0.81 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Cardiac Output Index | 3 Months | 2.54 L/min/m2 | Standard Deviation 0.67 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Cardiac Output Index | Discharge | 2.40 L/min/m2 | Standard Deviation 0.79 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Cardiac Output Index | 1 Year | 2.47 L/min/m2 | Standard Deviation 0.68 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Cardiac Output Index | 3 Months | 2.33 L/min/m2 | Standard Deviation 0.62 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Cardiac Output Index | Discharge | 2.44 L/min/m2 | Standard Deviation 0.75 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Cardiac Output Index | 1 Year | 2.49 L/min/m2 | Standard Deviation 0.71 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Cardiac Output Index | 3 Months | 2.21 L/min/m2 | Standard Deviation 0.65 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Cardiac Output Index | Discharge | 2.54 L/min/m2 | Standard Deviation 0.72 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Cardiac Output Index | 1 Year | 2.32 L/min/m2 | Standard Deviation 0.65 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Cardiac Output Index | 3 Months | 2.61 L/min/m2 | Standard Deviation 1 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Cardiac Output Index | Discharge | 2.45 L/min/m2 | Standard Deviation 0.77 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Cardiac Output Index | 1 Year | 2.88 L/min/m2 | Standard Deviation 1.09 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Cardiac Output Index | Discharge | 2.45 L/min/m2 | Standard Deviation 0.78 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Cardiac Output Index | 1 Year | 2.45 L/min/m2 | Standard Deviation 0.74 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Cardiac Output Index | 3 Months | 2.40 L/min/m2 | Standard Deviation 0.72 |
Other Pre-specified
Subject's Average Cardiac Output Over Time
The amount of blood the heart pumps through the circulatory system in a minute.
Time frame: Discharge, 3 months, 1 year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Cardiac Output Over Time | 3 Months | 3.85 liters per minute | Standard Deviation 1.4 |
| INTUITY (Study Valve Cohort) | Subject's Average Cardiac Output Over Time | Discharge | 4.14 liters per minute | Standard Deviation 1.39 |
| INTUITY (Study Valve Cohort) | Subject's Average Cardiac Output Over Time | 1 Year | 3.86 liters per minute | Standard Deviation 1.28 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Cardiac Output Over Time | 3 Months | 4.36 liters per minute | Standard Deviation 1.15 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Cardiac Output Over Time | Discharge | 4.24 liters per minute | Standard Deviation 1.31 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Cardiac Output Over Time | 1 Year | 4.26 liters per minute | Standard Deviation 1.11 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Cardiac Output Over Time | 3 Months | 4.29 liters per minute | Standard Deviation 1.12 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Cardiac Output Over Time | Discharge | 4.60 liters per minute | Standard Deviation 1.33 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Cardiac Output Over Time | 1 Year | 4.61 liters per minute | Standard Deviation 1.3 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Cardiac Output Over Time | 3 Months | 4.16 liters per minute | Standard Deviation 1.19 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Cardiac Output Over Time | Discharge | 4.74 liters per minute | Standard Deviation 1.48 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Cardiac Output Over Time | 1 Year | 4.61 liters per minute | Standard Deviation 1.3 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Cardiac Output Over Time | 3 Months | 5.08 liters per minute | Standard Deviation 1.57 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Cardiac Output Over Time | Discharge | 5.09 liters per minute | Standard Deviation 1.82 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Cardiac Output Over Time | 1 Year | 5.90 liters per minute | Standard Deviation 1.76 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Cardiac Output Over Time | Discharge | 4.49 liters per minute | Standard Deviation 1.42 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Cardiac Output Over Time | 1 Year | 4.50 liters per minute | Standard Deviation 1.37 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Cardiac Output Over Time | 3 Months | 4.26 liters per minute | Standard Deviation 1.23 |
Other Pre-specified
Subject's Average Effective Orifice Area Index (EOAI) Measurements
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: Baseline, Discharge, 3 months, 1 year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Baseline | 0.37 centimeters squared/meters squared | Standard Deviation 0.1 |
| INTUITY (Study Valve Cohort) | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Discharge | 0.69 centimeters squared/meters squared | Standard Deviation 0.26 |
| INTUITY (Study Valve Cohort) | Subject's Average Effective Orifice Area Index (EOAI) Measurements | 3 Months | 0.69 centimeters squared/meters squared | Standard Deviation 0.24 |
| INTUITY (Study Valve Cohort) | Subject's Average Effective Orifice Area Index (EOAI) Measurements | 1 Year | 0.76 centimeters squared/meters squared | Standard Deviation 0.21 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | 3 Months | 0.91 centimeters squared/meters squared | Standard Deviation 0.31 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Discharge | 0.92 centimeters squared/meters squared | Standard Deviation 0.31 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Baseline | 0.41 centimeters squared/meters squared | Standard Deviation 0.18 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | 1 Year | 0.92 centimeters squared/meters squared | Standard Deviation 0.26 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | 1 Year | 1.06 centimeters squared/meters squared | Standard Deviation 0.22 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | 3 Months | 0.99 centimeters squared/meters squared | Standard Deviation 0.4 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Discharge | 1.05 centimeters squared/meters squared | Standard Deviation 0.34 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Baseline | 0.40 centimeters squared/meters squared | Standard Deviation 0.17 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Baseline | 0.37 centimeters squared/meters squared | Standard Deviation 0.14 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | 1 Year | 1.13 centimeters squared/meters squared | Standard Deviation 0.33 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Discharge | 1.15 centimeters squared/meters squared | Standard Deviation 0.35 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | 3 Months | 1.09 centimeters squared/meters squared | Standard Deviation 0.34 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | 3 Months | 1.23 centimeters squared/meters squared | Standard Deviation 0.42 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | 1 Year | 1.30 centimeters squared/meters squared | Standard Deviation 0.48 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Discharge | 1.40 centimeters squared/meters squared | Standard Deviation 0.5 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Baseline | 0.40 centimeters squared/meters squared | Standard Deviation 0.12 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Discharge | 0.99 centimeters squared/meters squared | Standard Deviation 0.38 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Effective Orifice Area Index (EOAI) Measurements | 3 Months | 0.96 centimeters squared/meters squared | Standard Deviation 0.37 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Effective Orifice Area Index (EOAI) Measurements | 1 Year | 1.01 centimeters squared/meters squared | Standard Deviation 0.31 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Baseline | 0.39 centimeters squared/meters squared | Standard Deviation 0.16 |
Other Pre-specified
Subject's Average Effective Orifice Area Measurements
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Time frame: Baseline, discharge, 3 months, 1 year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Effective Orifice Area Measurements | Baseline | 0.62 Centimeters squared | Standard Deviation 0.16 |
| INTUITY (Study Valve Cohort) | Subject's Average Effective Orifice Area Measurements | Discharge | 1.17 Centimeters squared | Standard Deviation 0.41 |
| INTUITY (Study Valve Cohort) | Subject's Average Effective Orifice Area Measurements | 3 Months | 1.14 Centimeters squared | Standard Deviation 0.39 |
| INTUITY (Study Valve Cohort) | Subject's Average Effective Orifice Area Measurements | 1 Year | 1.28 Centimeters squared | Standard Deviation 0.33 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Effective Orifice Area Measurements | 3 Months | 1.59 Centimeters squared | Standard Deviation 0.52 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Effective Orifice Area Measurements | Discharge | 1.66 Centimeters squared | Standard Deviation 0.53 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Effective Orifice Area Measurements | Baseline | 0.71 Centimeters squared | Standard Deviation 0.29 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Effective Orifice Area Measurements | 1 Year | 1.61 Centimeters squared | Standard Deviation 0.43 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Effective Orifice Area Measurements | Discharge | 2.00 Centimeters squared | Standard Deviation 0.64 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Effective Orifice Area Measurements | 1 Year | 1.97 Centimeters squared | Standard Deviation 0.42 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Effective Orifice Area Measurements | 3 Months | 1.86 Centimeters squared | Standard Deviation 0.62 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Effective Orifice Area Measurements | Baseline | 0.75 Centimeters squared | Standard Deviation 0.34 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Effective Orifice Area Measurements | Baseline | 0.74 Centimeters squared | Standard Deviation 0.26 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Effective Orifice Area Measurements | Discharge | 2.18 Centimeters squared | Standard Deviation 0.7 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Effective Orifice Area Measurements | 1 Year | 2.23 Centimeters squared | Standard Deviation 0.65 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Effective Orifice Area Measurements | 3 Months | 2.10 Centimeters squared | Standard Deviation 0.59 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Effective Orifice Area Measurements | Baseline | 0.81 Centimeters squared | Standard Deviation 0.25 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Effective Orifice Area Measurements | 3 Months | 2.54 Centimeters squared | Standard Deviation 0.77 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Effective Orifice Area Measurements | Discharge | 2.83 Centimeters squared | Standard Deviation 0.9 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Effective Orifice Area Measurements | 1 Year | 2.64 Centimeters squared | Standard Deviation 0.73 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Effective Orifice Area Measurements | Discharge | 1.86 Centimeters squared | Standard Deviation 0.73 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Effective Orifice Area Measurements | Baseline | 0.72 Centimeters squared | Standard Deviation 0.29 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Effective Orifice Area Measurements | 3 Months | 1.77 Centimeters squared | Standard Deviation 0.67 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Effective Orifice Area Measurements | 1 Year | 1.88 Centimeters squared | Standard Deviation 0.63 |
Other Pre-specified
Subject's Average Health Care Utilization
The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure.
Time frame: Day of surgical procedure through discharge from the ICU and hospital, an average of 3 days and 11 days respectively.
Population: The outcome is reported for subjects where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Health Care Utilization | Hospital Length of Stay | 11.2 Days | Standard Deviation 18.4 |
| INTUITY (Study Valve Cohort) | Subject's Average Health Care Utilization | ICU Length of Stay | 2.8 Days | Standard Deviation 3.9 |
Other Pre-specified
Subject's Average Left Ventricular Ejection Fraction (LVEF)
Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. Ejection fraction is evaluated by echocardiography over time. A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%.
Time frame: Baseline, discharge, 3 months, 1 year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Baseline | 66.71 Percentage of blood | Standard Deviation 9.85 |
| INTUITY (Study Valve Cohort) | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Discharge | 66.05 Percentage of blood | Standard Deviation 11.4 |
| INTUITY (Study Valve Cohort) | Subject's Average Left Ventricular Ejection Fraction (LVEF) | 3 Months | 64.58 Percentage of blood | Standard Deviation 6.96 |
| INTUITY (Study Valve Cohort) | Subject's Average Left Ventricular Ejection Fraction (LVEF) | 1 Year | 64.28 Percentage of blood | Standard Deviation 8.12 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | 3 Months | 66.26 Percentage of blood | Standard Deviation 9.88 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Discharge | 64.16 Percentage of blood | Standard Deviation 11.63 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Baseline | 65.87 Percentage of blood | Standard Deviation 11.89 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | 1 Year | 64.64 Percentage of blood | Standard Deviation 8.23 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | 1 Year | 64.65 Percentage of blood | Standard Deviation 8.98 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | 3 Months | 65.20 Percentage of blood | Standard Deviation 9.51 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Discharge | 65.87 Percentage of blood | Standard Deviation 10.7 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Baseline | 64.56 Percentage of blood | Standard Deviation 11.73 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Baseline | 60.57 Percentage of blood | Standard Deviation 12.85 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | 1 Year | 63.30 Percentage of blood | Standard Deviation 7.75 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Discharge | 60.45 Percentage of blood | Standard Deviation 12.57 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | 3 Months | 62.36 Percentage of blood | Standard Deviation 11.29 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | 3 Months | 63.08 Percentage of blood | Standard Deviation 10.24 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | 1 Year | 63.64 Percentage of blood | Standard Deviation 9.35 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Discharge | 61.12 Percentage of blood | Standard Deviation 13.36 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Baseline | 62.96 Percentage of blood | Standard Deviation 9.29 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Discharge | 64.16 Percentage of blood | Standard Deviation 11.73 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Left Ventricular Ejection Fraction (LVEF) | 3 Months | 64.67 Percentage of blood | Standard Deviation 9.79 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Left Ventricular Ejection Fraction (LVEF) | 1 Year | 64.23 Percentage of blood | Standard Deviation 8.41 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Baseline | 64.37 Percentage of blood | Standard Deviation 11.75 |
Other Pre-specified
Subject's Average Left Ventricular End-Diastolic Dimension
The measurement of the heart's left ventricle at end diastole.
Time frame: Baseline, Discharge, 3 Months, 1 Year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Left Ventricular End-Diastolic Dimension | Baseline | 4.05 centimeters | Standard Deviation 0.58 |
| INTUITY (Study Valve Cohort) | Subject's Average Left Ventricular End-Diastolic Dimension | Discharge | 3.92 centimeters | Standard Deviation 0.67 |
| INTUITY (Study Valve Cohort) | Subject's Average Left Ventricular End-Diastolic Dimension | 3 Months | 3.93 centimeters | Standard Deviation 0.59 |
| INTUITY (Study Valve Cohort) | Subject's Average Left Ventricular End-Diastolic Dimension | 1 Year | 3.98 centimeters | Standard Deviation 0.64 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Left Ventricular End-Diastolic Dimension | 3 Months | 4.17 centimeters | Standard Deviation 0.59 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Left Ventricular End-Diastolic Dimension | Discharge | 4.09 centimeters | Standard Deviation 0.68 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Left Ventricular End-Diastolic Dimension | Baseline | 4.30 centimeters | Standard Deviation 0.74 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Left Ventricular End-Diastolic Dimension | 1 Year | 4.08 centimeters | Standard Deviation 0.71 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Left Ventricular End-Diastolic Dimension | 1 Year | 4.43 centimeters | Standard Deviation 0.54 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Left Ventricular End-Diastolic Dimension | 3 Months | 4.25 centimeters | Standard Deviation 0.62 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Left Ventricular End-Diastolic Dimension | Discharge | 4.35 centimeters | Standard Deviation 0.65 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Left Ventricular End-Diastolic Dimension | Baseline | 4.38 centimeters | Standard Deviation 0.63 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Left Ventricular End-Diastolic Dimension | Baseline | 4.76 centimeters | Standard Deviation 0.72 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Left Ventricular End-Diastolic Dimension | 1 Year | 4.47 centimeters | Standard Deviation 0.72 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Left Ventricular End-Diastolic Dimension | Discharge | 4.51 centimeters | Standard Deviation 0.73 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Left Ventricular End-Diastolic Dimension | 3 Months | 4.55 centimeters | Standard Deviation 0.68 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Left Ventricular End-Diastolic Dimension | 3 Months | 4.88 centimeters | Standard Deviation 0.79 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Left Ventricular End-Diastolic Dimension | 1 Year | 4.72 centimeters | Standard Deviation 0.64 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Left Ventricular End-Diastolic Dimension | Discharge | 4.67 centimeters | Standard Deviation 1.3 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Left Ventricular End-Diastolic Dimension | Baseline | 4.92 centimeters | Standard Deviation 0.67 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Left Ventricular End-Diastolic Dimension | Discharge | 4.27 centimeters | Standard Deviation 0.76 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Left Ventricular End-Diastolic Dimension | 3 Months | 4.29 centimeters | Standard Deviation 0.67 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Left Ventricular End-Diastolic Dimension | 1 Year | 4.30 centimeters | Standard Deviation 0.68 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Left Ventricular End-Diastolic Dimension | Baseline | 4.41 centimeters | Standard Deviation 0.72 |
Other Pre-specified
Subject's Average Left Ventricular End-Systolic Dimension
The measurement of the heart's left ventricle at end systole.
Time frame: Baseline, Discharge, 3 Months, 1 Year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Left Ventricular End-Systolic Dimension | Baseline | 2.63 centimeters | Standard Deviation 0.6 |
| INTUITY (Study Valve Cohort) | Subject's Average Left Ventricular End-Systolic Dimension | Discharge | 2.60 centimeters | Standard Deviation 0.65 |
| INTUITY (Study Valve Cohort) | Subject's Average Left Ventricular End-Systolic Dimension | 3 Months | 2.53 centimeters | Standard Deviation 0.56 |
| INTUITY (Study Valve Cohort) | Subject's Average Left Ventricular End-Systolic Dimension | 1 Year | 2.63 centimeters | Standard Deviation 0.61 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Left Ventricular End-Systolic Dimension | 3 Months | 2.70 centimeters | Standard Deviation 0.62 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Left Ventricular End-Systolic Dimension | Discharge | 2.80 centimeters | Standard Deviation 0.73 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Left Ventricular End-Systolic Dimension | Baseline | 2.80 centimeters | Standard Deviation 0.75 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Left Ventricular End-Systolic Dimension | 1 Year | 2.69 centimeters | Standard Deviation 0.69 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Left Ventricular End-Systolic Dimension | 1 Year | 2.90 centimeters | Standard Deviation 0.54 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Left Ventricular End-Systolic Dimension | 3 Months | 2.81 centimeters | Standard Deviation 0.56 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Left Ventricular End-Systolic Dimension | Discharge | 2.97 centimeters | Standard Deviation 0.69 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Left Ventricular End-Systolic Dimension | Baseline | 2.99 centimeters | Standard Deviation 0.72 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Left Ventricular End-Systolic Dimension | Baseline | 3.29 centimeters | Standard Deviation 0.91 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Left Ventricular End-Systolic Dimension | 1 Year | 2.91 centimeters | Standard Deviation 0.68 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Left Ventricular End-Systolic Dimension | Discharge | 3.07 centimeters | Standard Deviation 0.7 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Left Ventricular End-Systolic Dimension | 3 Months | 3.02 centimeters | Standard Deviation 0.67 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Left Ventricular End-Systolic Dimension | 3 Months | 3.31 centimeters | Standard Deviation 0.75 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Left Ventricular End-Systolic Dimension | 1 Year | 3.06 centimeters | Standard Deviation 0.68 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Left Ventricular End-Systolic Dimension | Discharge | 3.32 centimeters | Standard Deviation 0.84 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Left Ventricular End-Systolic Dimension | Baseline | 3.36 centimeters | Standard Deviation 0.82 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Left Ventricular End-Systolic Dimension | Discharge | 2.92 centimeters | Standard Deviation 0.72 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Left Ventricular End-Systolic Dimension | 3 Months | 2.82 centimeters | Standard Deviation 0.64 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Left Ventricular End-Systolic Dimension | 1 Year | 2.82 centimeters | Standard Deviation 0.64 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Left Ventricular End-Systolic Dimension | Baseline | 2.96 centimeters | Standard Deviation 0.79 |
Other Pre-specified
Subject's Average Mean Gradient Measurements
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Time frame: Baseline, discharge, 3 months, and 1 year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Mean Gradient Measurements | Baseline | 51.22 mmHg | Standard Deviation 21.24 |
| INTUITY (Study Valve Cohort) | Subject's Average Mean Gradient Measurements | Discharge | 15.83 mmHg | Standard Deviation 8.35 |
| INTUITY (Study Valve Cohort) | Subject's Average Mean Gradient Measurements | 3 months | 14.58 mmHg | Standard Deviation 8.26 |
| INTUITY (Study Valve Cohort) | Subject's Average Mean Gradient Measurements | 1 Year | 13.16 mmHg | Standard Deviation 6.9 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Mean Gradient Measurements | 3 months | 10.96 mmHg | Standard Deviation 6.01 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Mean Gradient Measurements | Discharge | 11.74 mmHg | Standard Deviation 6.42 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Mean Gradient Measurements | Baseline | 49.11 mmHg | Standard Deviation 16.81 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Mean Gradient Measurements | 1 Year | 10.14 mmHg | Standard Deviation 4.28 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Mean Gradient Measurements | 1 Year | 8.96 mmHg | Standard Deviation 3.72 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Mean Gradient Measurements | 3 months | 9.73 mmHg | Standard Deviation 5.98 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Mean Gradient Measurements | Discharge | 10.69 mmHg | Standard Deviation 5.98 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Mean Gradient Measurements | Baseline | 47.51 mmHg | Standard Deviation 16.7 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Mean Gradient Measurements | Baseline | 44.36 mmHg | Standard Deviation 13.33 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Mean Gradient Measurements | 1 Year | 8.45 mmHg | Standard Deviation 3.03 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Mean Gradient Measurements | Discharge | 10.69 mmHg | Standard Deviation 7.65 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Mean Gradient Measurements | 3 months | 8.34 mmHg | Standard Deviation 4.68 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Mean Gradient Measurements | 3 months | 7.38 mmHg | Standard Deviation 2.8 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Mean Gradient Measurements | 1 Year | 7.25 mmHg | Standard Deviation 3.13 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Mean Gradient Measurements | Discharge | 7.77 mmHg | Standard Deviation 2.96 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Mean Gradient Measurements | Baseline | 44.83 mmHg | Standard Deviation 14.79 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Mean Gradient Measurements | Discharge | 11.61 mmHg | Standard Deviation 7 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Mean Gradient Measurements | 3 months | 10.36 mmHg | Standard Deviation 6.34 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Mean Gradient Measurements | 1 Year | 9.64 mmHg | Standard Deviation 4.6 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Mean Gradient Measurements | Baseline | 47.74 mmHg | Standard Deviation 16.9 |
Other Pre-specified
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: Baseline, discharge, 3 months, and 1 year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Peak Gradients (mmHg) Measurements Over Time | 3 Months | 27.46 mmHg | Standard Deviation 13.64 |
| INTUITY (Study Valve Cohort) | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Discharge | 29.42 mmHg | Standard Deviation 12.83 |
| INTUITY (Study Valve Cohort) | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Baseline | 83.75 mmHg | Standard Deviation 33.17 |
| INTUITY (Study Valve Cohort) | Subject's Average Peak Gradients (mmHg) Measurements Over Time | 1 Year | 23.88 mmHg | Standard Deviation 8.57 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Baseline | 78.92 mmHg | Standard Deviation 28.21 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | 3 Months | 21.12 mmHg | Standard Deviation 10.32 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Discharge | 21.88 mmHg | Standard Deviation 10.53 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | 1 Year | 18.29 mmHg | Standard Deviation 7.17 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Discharge | 20.29 mmHg | Standard Deviation 9.75 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Baseline | 77.08 mmHg | Standard Deviation 25.15 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | 3 Months | 19.48 mmHg | Standard Deviation 11.9 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | 1 Year | 16.97 mmHg | Standard Deviation 6.77 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | 1 Year | 15.40 mmHg | Standard Deviation 4.94 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Baseline | 73.11 mmHg | Standard Deviation 20.92 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Discharge | 19.78 mmHg | Standard Deviation 12.28 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | 3 Months | 16.52 mmHg | Standard Deviation 7.82 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | 3 Months | 14.00 mmHg | Standard Deviation 4.96 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Baseline | 72.51 mmHg | Standard Deviation 21.22 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | 1 Year | 13.29 mmHg | Standard Deviation 5.37 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Discharge | 14.00 mmHg | Standard Deviation 5.63 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Discharge | 21.65 mmHg | Standard Deviation 11.4 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Baseline | 77.56 mmHg | Standard Deviation 26.55 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Peak Gradients (mmHg) Measurements Over Time | 1 Year | 17.70 mmHg | Standard Deviation 7.31 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Peak Gradients (mmHg) Measurements Over Time | 3 Months | 20.18 mmHg | Standard Deviation 11.32 |
Other Pre-specified
Subject's Average Performance Index Measurements
Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.
Time frame: Discharge, 3 Months, 1 Year
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Performance Index Measurements | 3 Months | 0.44 cm^2/cm^2 | Standard Deviation 0.12 |
| INTUITY (Study Valve Cohort) | Subject's Average Performance Index Measurements | Discharge | 0.44 cm^2/cm^2 | Standard Deviation 0.12 |
| INTUITY (Study Valve Cohort) | Subject's Average Performance Index Measurements | 1 Year | 0.48 cm^2/cm^2 | Standard Deviation 0.12 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Performance Index Measurements | 3 Months | 0.50 cm^2/cm^2 | Standard Deviation 0.12 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Performance Index Measurements | Discharge | 0.49 cm^2/cm^2 | Standard Deviation 0.13 |
| INTUITY (Study Valve Cohort) - 21mm | Subject's Average Performance Index Measurements | 1 Year | 0.51 cm^2/cm^2 | Standard Deviation 0.14 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Performance Index Measurements | 3 Months | 0.55 cm^2/cm^2 | Standard Deviation 0.13 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Performance Index Measurements | Discharge | 0.53 cm^2/cm^2 | Standard Deviation 0.14 |
| INTUITY (Study Valve Cohort) - 23mm | Subject's Average Performance Index Measurements | 1 Year | 0.55 cm^2/cm^2 | Standard Deviation 0.12 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Performance Index Measurements | 3 Months | 0.52 cm^2/cm^2 | Standard Deviation 0.13 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Performance Index Measurements | Discharge | 0.49 cm^2/cm^2 | Standard Deviation 0.12 |
| INTUITY (Study Valve Cohort) - 25mm | Subject's Average Performance Index Measurements | 1 Year | 0.53 cm^2/cm^2 | Standard Deviation 0.13 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Performance Index Measurements | 3 Months | 0.57 cm^2/cm^2 | Standard Deviation 0.13 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Performance Index Measurements | Discharge | 0.56 cm^2/cm^2 | Standard Deviation 0.12 |
| INTUITY (Study Valve Cohort) - 27mm | Subject's Average Performance Index Measurements | 1 Year | 0.58 cm^2/cm^2 | Standard Deviation 0.13 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Performance Index Measurements | Discharge | 0.50 cm^2/cm^2 | Standard Deviation 0.13 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Performance Index Measurements | 1 Year | 0.53 cm^2/cm^2 | Standard Deviation 0.13 |
| INTUITY (Study Valve Cohort) - Overall | Subject's Average Performance Index Measurements | 3 Months | 0.52 cm^2/cm^2 | Standard Deviation 0.13 |
Other Pre-specified
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Time frame: Baseline, 3 months
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | Baseline | 0.818 units on a scale | Standard Deviation 0.137 |
| INTUITY (Study Valve Cohort) | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | 3 Months | 0.864 units on a scale | Standard Deviation 0.149 |
| INTUITY (Study Valve Cohort) | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | Change from Baseline to 3 Months | 0.040 units on a scale | Standard Deviation 0.131 |
Other Pre-specified
Subject's Average Skin-to-skin Time
The time from start of skin incision to end of skin closure.
Time frame: At time of surgery; an average of 3.5 hours
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Skin-to-skin Time | 199.3 Minutes | Standard Deviation 69.8 |
Other Pre-specified
Subject's Average Time 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 1.5 hours
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Average Time Spent on Cardiopulmonary Bypass | 85.9 minutes | Standard Deviation 33 |
Other Pre-specified
Subject's Device Technical Success
Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with the subject leaving the operating room (OR) with valve in place.
Time frame: At time of surgery
Population: The outcome is reported for subjects where data is available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's Device Technical Success | 493 Participants |
Other Pre-specified
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. 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: 30 days, 3 months, 1 year, 2 years
Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| INTUITY (Study Valve Cohort) | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Year | Improved | 293 Participants |
| INTUITY (Study Valve Cohort) | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 30 Days | Improved | 272 Participants |
| INTUITY (Study Valve Cohort) | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 30 Days | Same | 129 Participants |
| INTUITY (Study Valve Cohort) | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 30 Days | Worsened | 17 Participants |
| INTUITY (Study Valve Cohort) | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Months | Improved | 326 Participants |
| INTUITY (Study Valve Cohort) | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Months | Same | 99 Participants |
| INTUITY (Study Valve Cohort) | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Months | Worsened | 8 Participants |
| INTUITY (Study Valve Cohort) | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Year | Same | 63 Participants |
| INTUITY (Study Valve Cohort) | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Year | Worsened | 8 Participants |
| INTUITY (Study Valve Cohort) | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 2 Year | Improved | 255 Participants |
| INTUITY (Study Valve Cohort) | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 2 Year | Same | 80 Participants |
| INTUITY (Study Valve Cohort) | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 2 Year | Worsened | 15 Participants |