Aortic Valve Incompetence, Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve
Conditions
Keywords
Aortic valve, Heart valve, Tissue valve, Bioprosthesis, Valve disorder, Valve disease, Cardiac surgery, Less invasive cardiac surgery, Aortic valve stenosis, Aortic valve regurgitation, Bovine pericardium
Brief summary
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
Detailed description
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of five years.
Interventions
DEVICEEDWARDS INTUITY valve
Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria - Subjects will be required to meet all inclusion criteria: 1. Male or female, age 18 years or older 2. Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replacement as indicated in the preoperative evaluation 3. Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery 4. Provide written informed consent 5. Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Events occurring ≥ 31 days and up through 8 years post-implant | Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Days Subjects Were in the Intensive Care Unit (ICU) | Day of procedure through discharge from the hospital | Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure. |
| Subject's Effective Orifice Area (EOA) Measurement Over Time | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | 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. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve. |
| Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve. |
| Subject's Performance Index Measurement Over Time | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | 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. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve. |
| Subject's Cardiac Output Measurement at Over Time | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse. |
| Subject's Cardiac Index Measurement Over Time | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | Hemodynamic performance - Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m\^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient. |
| Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | Valvular regurgitation occurs when the 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. 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. Higher numbers on the scale show a worsening outcome. |
| Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success | Day of procedure | Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place. |
| Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success | Day of procedure through discharge or 10 days post index procedure, whichever comes first. | Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first. |
| Average Amount of Time Subject Spent on Cardiopulmonary Bypass | Day of procedure | Surgical and hospitalization factors - Cardiopulmonary bypass time |
| Average Subject Time on Cardiopulmonary Cross Clamp | Day of procedure | Surgical and hospitalization factors - Cardiopulmonary cross clamp time |
| Subject's New York Heart Association (NYHA) Classification Over Time | Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 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 Mean Gradient Measurements Over Time | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve. |
| Subject's Average Peak Gradient Measurements Over Time | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up | 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. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject's Average Red Blood Cell Count Over Time | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10\^6 cells/microliters and for men is 4.7 to 6.1 10\^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range can indicate something is wrong. |
| Subject's Average Hematocrit Percentage Over Time | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong. |
| Subject's Average Hemoglobin Percentage Over Time | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong. |
| Subject's Average Plasma Free Hemoglobin Over Time | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | Laboratory Analysis of Plasma Free Hemoglobin (Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong. |
| Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Baseline and one year follow-up | The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status. |
| Subject's Average White Blood Cell Count Over Time | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10 10\^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Edwards TRANSFORM Trial Cohort Subjects who were enrolled in the TRANSFORM trial and were eligible to receive an Edwards INTUITY surgical aortic heart valve. | 934 |
| Total | 934 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 186 |
| Overall Study | Lost to Follow-up | 47 |
| Overall Study | Withdrawal by Subject | 183 |
Baseline characteristics
| Characteristic | Edwards TRANSFORM Trial Cohort |
|---|---|
| Age, Continuous | 73.4 Years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 865 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 65 Participants |
| Region of Enrollment United States | 934 participants |
| Sex: Female, Male Female | 336 Participants |
| Sex: Female, Male Male | 598 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 178 / 885 | 8 / 49 |
| other Total, other adverse events | 868 / 885 | 47 / 49 |
| serious Total, serious adverse events | 756 / 885 | 37 / 49 |
Outcome results
Primary
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort
Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]
Time frame: Events occurring ≥ 31 days and up through 8 years post-implant
Population: The group of subjects that received the Edwards INTUITY surgical aortic heart valve.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Conduction defects with permanent pacemaker | 0.1 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Conduction defects without permanent pacemaker | 0.3 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | All cause mortality | 3.9 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Valve related mortality | 0.9 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Study valve reoperation | 0.6 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Study valve explant | 0.3 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Thromboembolism | 1.8 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Valve thrombosis | 0.0 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Endocarditis | 0.1 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | All bleeding | 4.7 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Major bleeding | 2.4 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | All paravalvular leak | 0.5 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Major paravalvular leak (PVL) | 0.3 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Hemolysis | 0.2 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Non-structural valve dysfunction other than PVL | 0.1 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Valve migration/embolization | 0.0 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Valve malposition | 0.0 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Valve instability | 0.0 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Valve dislodgement | 0.0 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Valve stenosis | 0.1 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Structural valve deterioration | 0.4 Percentage of events/late patient years |
| Edwards INTUITY Surgical Aortic Heart Valve | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Conduction defects | 0.4 Percentage of events/late patient years |
Secondary
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size
Valvular regurgitation occurs when the 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. 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. Higher numbers on the scale show a worsening outcome.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | None (0)/Trival (+1) | 7 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Mild (+2) | 5 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Mild (+2) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Mild (+2) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | None (0)/Trival (+1) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Mild (+2) | 4 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | None (0)/Trival (+1) | 20 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | None (0)/Trival (+1) | 31 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0)/Trival (+1) | 43 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | None (0)/Trival (+1) | 40 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Mild (+2) | 5 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | None (0)/Trival (+1) | 38 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0)/Trival (+1) | 46 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | None (0)/Trival (+1) | 26 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | None (0)/Trival (+1) | 33 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Mild (+2) | 5 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Mild (+2) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Mild (+2) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 12 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Mild (+2) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Moderate (+3) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | None (0)/Trival (+1) | 25 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Mild (+2) | 8 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | None (0)/Trival (+1) | 6 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | None (0)/Trival (+1) | 138 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Mild (+2) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Mild (+2) | 7 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | None (0)/Trival (+1) | 87 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0)/Trival (+1) | 156 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Mild (+2) | 7 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0)/Trival (+1) | 171 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | None (0)/Trival (+1) | 104 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | None (0)/Trival (+1) | 53 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | None (0)/Trival (+1) | 120 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | None (0)/Trival (+1) | 156 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Mild (+2) | 9 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Mild (+2) | 9 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Mild (+2) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 3 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Mild (+2) | 9 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 4 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | None (0)/Trival (+1) | 229 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | None (0)/Trival (+1) | 245 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Mild (+2) | 17 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Mild (+2) | 18 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Moderate (+3) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | None (0)/Trival (+1) | 87 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | None (0)/Trival (+1) | 146 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Mild (+2) | 15 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Moderate (+3) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | None (0)/Trival (+1) | 30 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Mild (+2) | 5 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | None (0)/Trival (+1) | 10 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Mild (+2) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Moderate (+3) | 5 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Mild (+2) | 19 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Moderate (+3) | 4 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | None (0)/Trival (+1) | 211 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Mild (+2) | 18 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Moderate (+3) | 3 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0)/Trival (+1) | 266 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 12 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 4 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | None (0)/Trival (+1) | 191 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0)/Trival (+1) | 245 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 16 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | None (0)/Trival (+1) | 78 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Severe (+4) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Mild (+2) | 21 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | None (0)/Trival (+1) | 193 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 13 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | None (0)/Trival (+1) | 179 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Mild (+2) | 19 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | None (0)/Trival (+1) | 200 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0)/Trival (+1) | 219 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Mild (+2) | 18 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Mild (+2) | 18 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Mild (+2) | 10 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Severe (+4) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Moderate (+3) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Moderate (+3) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Mild (+2) | 6 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 18 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Moderate (+3) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | None (0)/Trival (+1) | 4 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | None (0)/Trival (+1) | 22 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 6 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Mild (+2) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Mild (+2) | 23 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Severe (+4) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | None (0)/Trival (+1) | 160 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0)/Trival (+1) | 235 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | None (0)/Trival (+1) | 129 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Moderate (+3) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Mild (+2) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Mild (+2) | 4 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Severe (+4) | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | None (0)/Trival (+1) | 86 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0)/Trival (+1) | 97 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Mild (+2) | 4 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Mild (+2) | 5 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Moderate (+3) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | None (0)/Trival (+1) | 61 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 2 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | None (0)/Trival (+1) | 31 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | None (0)/Trival (+1) | 79 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Mild (+2) | 5 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | None (0)/Trival (+1) | 77 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Moderate (+3) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 4 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 4 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0)/Trival (+1) | 97 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | Mild (+2) | 5 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 3 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 1 Year | None (0)/Trival (+1) | 89 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Mild (+2) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 4 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | None (0)/Trival (+1) | 2 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 3 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Severe (+4) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | Mild (+2) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 7 Years | None (0)/Trival (+1) | 6 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 6 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 8 Years | Moderate (+3) | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | 5 Years | Moderate (+3) | 1 Participants |
Secondary
Average Amount of Time Subject Spent on Cardiopulmonary Bypass
Surgical and hospitalization factors - Cardiopulmonary bypass time
Time frame: Day of procedure
Population: The group of subjects that received the Edwards INTUITY surgical aortic heart valve.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Average Amount of Time Subject Spent on Cardiopulmonary Bypass | 86.6 Minutes | Standard Deviation 37.4 |
Secondary
Average Number of Days Subjects Were in the Intensive Care Unit (ICU)
Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.
Time frame: Day of procedure through discharge from the hospital
Population: The group of subjects that received the Edwards INTUITY surgical aortic heart valve. Data is not available for 4 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Average Number of Days Subjects Were in the Intensive Care Unit (ICU) | 3.1 Days | Standard Deviation 3.7 |
Secondary
Average Subject Time on Cardiopulmonary Cross Clamp
Surgical and hospitalization factors - Cardiopulmonary cross clamp time
Time frame: Day of procedure
Population: The group of subjects that received the Edwards INTUITY surgical aortic heart valve. Data is not available for one subject.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Average Subject Time on Cardiopulmonary Cross Clamp | 65.4 Minutes | Standard Deviation 29.7 |
Secondary
Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success
Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.
Time frame: Day of procedure
Population: Patients who were eligible to receive an Edwards INTUITY surgical aortic heart valve.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success | 94.8 Percentage of subjects |
Secondary
Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success
Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.
Time frame: Day of procedure through discharge or 10 days post index procedure, whichever comes first.
Population: Patients who were eligible to receive an Edwards INTUITY surgical aortic heart valve.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success | 94.4 Percentage of subjects |
Secondary
Subject's Average Mean Gradient Measurements Over Time
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Mean Gradient Measurements Over Time | 4 Years | 12.8 mmHg | Standard Deviation 3.8 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Mean Gradient Measurements Over Time | 5 Years | 12.4 mmHg | Standard Deviation 3.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Mean Gradient Measurements Over Time | 3 Years | 13.7 mmHg | Standard Deviation 4.6 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Mean Gradient Measurements Over Time | 6 Years | 13.1 mmHg | Standard Deviation 3.9 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Mean Gradient Measurements Over Time | Discharge | 17.7 mmHg | Standard Deviation 6.2 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Mean Gradient Measurements Over Time | 3 months | 14.4 mmHg | Standard Deviation 4.4 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Mean Gradient Measurements Over Time | 7 Years | 12.1 mmHg | Standard Deviation 4 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Mean Gradient Measurements Over Time | 1 Year | 13.9 mmHg | Standard Deviation 4 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Mean Gradient Measurements Over Time | 2 Years | 13.1 mmHg | Standard Deviation 4.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Mean Gradient Measurements Over Time | 8 Years | 11.2 mmHg | Standard Deviation 0 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Mean Gradient Measurements Over Time | 7 Years | 10.8 mmHg | Standard Deviation 3.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Mean Gradient Measurements Over Time | 3 Years | 11.0 mmHg | Standard Deviation 4.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Mean Gradient Measurements Over Time | 3 months | 11.1 mmHg | Standard Deviation 3.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Mean Gradient Measurements Over Time | 6 Years | 10.5 mmHg | Standard Deviation 3.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Mean Gradient Measurements Over Time | 1 Year | 11.3 mmHg | Standard Deviation 3.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Mean Gradient Measurements Over Time | 5 Years | 10.7 mmHg | Standard Deviation 3.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Mean Gradient Measurements Over Time | 8 Years | 13.2 mmHg | Standard Deviation 5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Mean Gradient Measurements Over Time | 2 Years | 11.1 mmHg | Standard Deviation 3.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Mean Gradient Measurements Over Time | 4 Years | 10.8 mmHg | Standard Deviation 3.7 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Mean Gradient Measurements Over Time | Discharge | 13.0 mmHg | Standard Deviation 4.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Mean Gradient Measurements Over Time | 6 Years | 11.1 mmHg | Standard Deviation 6.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Mean Gradient Measurements Over Time | Discharge | 12.3 mmHg | Standard Deviation 4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Mean Gradient Measurements Over Time | 7 Years | 12.8 mmHg | Standard Deviation 7.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Mean Gradient Measurements Over Time | 3 Years | 10.0 mmHg | Standard Deviation 3.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Mean Gradient Measurements Over Time | 3 months | 10.3 mmHg | Standard Deviation 3.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Mean Gradient Measurements Over Time | 2 Years | 10.0 mmHg | Standard Deviation 3.7 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Mean Gradient Measurements Over Time | 4 Years | 10.3 mmHg | Standard Deviation 6.7 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Mean Gradient Measurements Over Time | 8 Years | 12.3 mmHg | Standard Deviation 8.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Mean Gradient Measurements Over Time | 5 Years | 10.0 mmHg | Standard Deviation 5.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Mean Gradient Measurements Over Time | 1 Year | 10.0 mmHg | Standard Deviation 3.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Mean Gradient Measurements Over Time | 3 months | 9.7 mmHg | Standard Deviation 3.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Mean Gradient Measurements Over Time | 7 Years | 9.8 mmHg | Standard Deviation 4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Mean Gradient Measurements Over Time | 8 Years | 12.9 mmHg | Standard Deviation 8.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Mean Gradient Measurements Over Time | Discharge | 11.2 mmHg | Standard Deviation 3.7 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Mean Gradient Measurements Over Time | 1 Year | 9.3 mmHg | Standard Deviation 3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Mean Gradient Measurements Over Time | 2 Years | 9.3 mmHg | Standard Deviation 2.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Mean Gradient Measurements Over Time | 3 Years | 9.5 mmHg | Standard Deviation 3.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Mean Gradient Measurements Over Time | 4 Years | 9.5 mmHg | Standard Deviation 4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Mean Gradient Measurements Over Time | 5 Years | 9.8 mmHg | Standard Deviation 6.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Mean Gradient Measurements Over Time | 6 Years | 9.3 mmHg | Standard Deviation 4 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Mean Gradient Measurements Over Time | 4 Years | 8.0 mmHg | Standard Deviation 3.7 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Mean Gradient Measurements Over Time | 1 Year | 8.1 mmHg | Standard Deviation 3.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Mean Gradient Measurements Over Time | 8 Years | 9.4 mmHg | Standard Deviation 2.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Mean Gradient Measurements Over Time | 6 Years | 9.2 mmHg | Standard Deviation 6.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Mean Gradient Measurements Over Time | 3 months | 8.3 mmHg | Standard Deviation 2.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Mean Gradient Measurements Over Time | 2 Years | 8.1 mmHg | Standard Deviation 3.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Mean Gradient Measurements Over Time | Discharge | 9.7 mmHg | Standard Deviation 3.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Mean Gradient Measurements Over Time | 7 Years | 7.7 mmHg | Standard Deviation 1.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Mean Gradient Measurements Over Time | 3 Years | 7.9 mmHg | Standard Deviation 2.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Mean Gradient Measurements Over Time | 5 Years | 7.9 mmHg | Standard Deviation 4.4 |
Secondary
Subject's Average Peak Gradient 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. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Peak Gradient Measurements Over Time | Discharge | 32.8 mmHg | Standard Deviation 11.9 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Peak Gradient Measurements Over Time | 8 Years | 21.3 mmHg | Standard Deviation 0 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Peak Gradient Measurements Over Time | 3 Years | 24.7 mmHg | Standard Deviation 8.2 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Peak Gradient Measurements Over Time | 7 Years | 22.1 mmHg | Standard Deviation 7.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Peak Gradient Measurements Over Time | 6 Years | 23.6 mmHg | Standard Deviation 6.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Peak Gradient Measurements Over Time | 5 Years | 22.7 mmHg | Standard Deviation 6.3 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Peak Gradient Measurements Over Time | 4 Years | 23.0 mmHg | Standard Deviation 6.6 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Peak Gradient Measurements Over Time | 2 Years | 23.4 mmHg | Standard Deviation 7.9 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Peak Gradient Measurements Over Time | 1 Year | 25.0 mmHg | Standard Deviation 7.7 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Peak Gradient Measurements Over Time | 3 months | 26.0 mmHg | Standard Deviation 8 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Peak Gradient Measurements Over Time | 7 Years | 19.6 mmHg | Standard Deviation 5.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Peak Gradient Measurements Over Time | 1 Year | 20.5 mmHg | Standard Deviation 6.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Peak Gradient Measurements Over Time | Discharge | 24.1 mmHg | Standard Deviation 7.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Peak Gradient Measurements Over Time | 3 months | 19.9 mmHg | Standard Deviation 6.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Peak Gradient Measurements Over Time | 2 Years | 20.2 mmHg | Standard Deviation 6.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Peak Gradient Measurements Over Time | 3 Years | 20.0 mmHg | Standard Deviation 7.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Peak Gradient Measurements Over Time | 4 Years | 19.8 mmHg | Standard Deviation 6.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Peak Gradient Measurements Over Time | 5 Years | 19.5 mmHg | Standard Deviation 7 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Peak Gradient Measurements Over Time | 6 Years | 19.1 mmHg | Standard Deviation 6.7 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Average Peak Gradient Measurements Over Time | 8 Years | 24.4 mmHg | Standard Deviation 8.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Peak Gradient Measurements Over Time | 3 months | 19.0 mmHg | Standard Deviation 6.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Peak Gradient Measurements Over Time | 5 Years | 18.4 mmHg | Standard Deviation 10 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Peak Gradient Measurements Over Time | 1 Year | 18.2 mmHg | Standard Deviation 6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Peak Gradient Measurements Over Time | 7 Years | 23.5 mmHg | Standard Deviation 13.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Peak Gradient Measurements Over Time | 2 Years | 18.4 mmHg | Standard Deviation 6.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Peak Gradient Measurements Over Time | 4 Years | 18.9 mmHg | Standard Deviation 10.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Peak Gradient Measurements Over Time | 8 Years | 21.0 mmHg | Standard Deviation 12.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Peak Gradient Measurements Over Time | 6 Years | 19.8 mmHg | Standard Deviation 9.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Peak Gradient Measurements Over Time | 3 Years | 18.5 mmHg | Standard Deviation 6.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Average Peak Gradient Measurements Over Time | Discharge | 22.9 mmHg | Standard Deviation 7.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Peak Gradient Measurements Over Time | 6 Years | 17.1 mmHg | Standard Deviation 7.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Peak Gradient Measurements Over Time | Discharge | 20.8 mmHg | Standard Deviation 6.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Peak Gradient Measurements Over Time | 7 Years | 18.5 mmHg | Standard Deviation 7.7 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Peak Gradient Measurements Over Time | 1 Year | 17.0 mmHg | Standard Deviation 5.7 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Peak Gradient Measurements Over Time | 4 Years | 17.6 mmHg | Standard Deviation 7.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Peak Gradient Measurements Over Time | 3 Years | 17.4 mmHg | Standard Deviation 6.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Peak Gradient Measurements Over Time | 8 Years | 22.7 mmHg | Standard Deviation 14.7 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Peak Gradient Measurements Over Time | 3 months | 17.6 mmHg | Standard Deviation 5.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Peak Gradient Measurements Over Time | 2 Years | 17.0 mmHg | Standard Deviation 5.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Average Peak Gradient Measurements Over Time | 5 Years | 17.9 mmHg | Standard Deviation 10.7 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Peak Gradient Measurements Over Time | 2 Years | 14.6 mmHg | Standard Deviation 6.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Peak Gradient Measurements Over Time | 8 Years | 17.2 mmHg | Standard Deviation 3.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Peak Gradient Measurements Over Time | 3 Years | 14.5 mmHg | Standard Deviation 5.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Peak Gradient Measurements Over Time | Discharge | 17.9 mmHg | Standard Deviation 5.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Peak Gradient Measurements Over Time | 5 Years | 14.5 mmHg | Standard Deviation 7.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Peak Gradient Measurements Over Time | 6 Years | 16.9 mmHg | Standard Deviation 10.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Peak Gradient Measurements Over Time | 1 Year | 14.6 mmHg | Standard Deviation 5.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Peak Gradient Measurements Over Time | 4 Years | 14.6 mmHg | Standard Deviation 6.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Peak Gradient Measurements Over Time | 3 months | 15.0 mmHg | Standard Deviation 4.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Average Peak Gradient Measurements Over Time | 7 Years | 14.6 mmHg | Standard Deviation 3.7 |
Secondary
Subject's Cardiac Index Measurement Over Time
Hemodynamic performance - Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m\^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Index Measurement Over Time | 4 Years | 2.3 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Index Measurement Over Time | 3 Years | 2.3 Liters/minutes/meters squared | Standard Deviation 0.4 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Index Measurement Over Time | Discharge | 2.5 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Index Measurement Over Time | 6 Years | 2.5 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Index Measurement Over Time | 8 Years | 1.5 Liters/minutes/meters squared | Standard Deviation 0 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Index Measurement Over Time | 7 Years | 2.3 Liters/minutes/meters squared | Standard Deviation 0.4 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Index Measurement Over Time | 2 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Index Measurement Over Time | 1 Year | 2.5 Liters/minutes/meters squared | Standard Deviation 0.6 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Index Measurement Over Time | 5 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Index Measurement Over Time | 3 months | 2.6 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Index Measurement Over Time | 5 Years | 2.3 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Index Measurement Over Time | 1 Year | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Index Measurement Over Time | 2 Years | 2.3 Liters/minutes/meters squared | Standard Deviation 0.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Index Measurement Over Time | Discharge | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Index Measurement Over Time | 3 Years | 2.3 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Index Measurement Over Time | 4 Years | 2.3 Liters/minutes/meters squared | Standard Deviation 0.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Index Measurement Over Time | 3 months | 2.4 Liters/minutes/meters squared | Standard Deviation 0.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Index Measurement Over Time | 7 Years | 2.2 Liters/minutes/meters squared | Standard Deviation 0.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Index Measurement Over Time | 8 Years | 2.6 Liters/minutes/meters squared | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Index Measurement Over Time | 6 Years | 2.3 Liters/minutes/meters squared | Standard Deviation 0.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Index Measurement Over Time | 2 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Index Measurement Over Time | 4 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Index Measurement Over Time | 5 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Index Measurement Over Time | Discharge | 2.7 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Index Measurement Over Time | 1 Year | 2.4 Liters/minutes/meters squared | Standard Deviation 0.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Index Measurement Over Time | 3 months | 2.5 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Index Measurement Over Time | 6 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Index Measurement Over Time | 7 Years | 2.5 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Index Measurement Over Time | 8 Years | 2.6 Liters/minutes/meters squared | Standard Deviation 0.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Index Measurement Over Time | 3 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Index Measurement Over Time | Discharge | 2.6 Liters/minutes/meters squared | Standard Deviation 0.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Index Measurement Over Time | 8 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Index Measurement Over Time | 5 Years | 2.3 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Index Measurement Over Time | 3 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Index Measurement Over Time | 4 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Index Measurement Over Time | 2 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Index Measurement Over Time | 6 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Index Measurement Over Time | 3 months | 2.5 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Index Measurement Over Time | 7 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Index Measurement Over Time | 1 Year | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Index Measurement Over Time | 2 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.4 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Index Measurement Over Time | Discharge | 2.7 Liters/minutes/meters squared | Standard Deviation 0.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Index Measurement Over Time | 3 months | 2.5 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Index Measurement Over Time | 4 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Index Measurement Over Time | 6 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Index Measurement Over Time | 1 Year | 2.5 Liters/minutes/meters squared | Standard Deviation 0.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Index Measurement Over Time | 8 Years | 2.8 Liters/minutes/meters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Index Measurement Over Time | 7 Years | 2.3 Liters/minutes/meters squared | Standard Deviation 0.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Index Measurement Over Time | 3 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Index Measurement Over Time | 5 Years | 2.4 Liters/minutes/meters squared | Standard Deviation 0.4 |
Secondary
Subject's Cardiac Output Measurement at Over Time
Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Output Measurement at Over Time | 5 Years | 4.2 Liters/minutes | Standard Deviation 0.7 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Output Measurement at Over Time | 7 Years | 3.9 Liters/minutes | Standard Deviation 0.6 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Output Measurement at Over Time | 6 Years | 4.3 Liters/minutes | Standard Deviation 0.7 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Output Measurement at Over Time | 3 months | 4.3 Liters/minutes | Standard Deviation 0.7 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Output Measurement at Over Time | Discharge | 4.3 Liters/minutes | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Output Measurement at Over Time | 2 Years | 4.1 Liters/minutes | Standard Deviation 0.8 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Output Measurement at Over Time | 8 Years | 2.9 Liters/minutes | Standard Deviation 0 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Output Measurement at Over Time | 3 Years | 4.0 Liters/minutes | Standard Deviation 0.7 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Output Measurement at Over Time | 4 Years | 4.1 Liters/minutes | Standard Deviation 0.8 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Cardiac Output Measurement at Over Time | 1 Year | 4.3 Liters/minutes | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Output Measurement at Over Time | 8 Years | 4.9 Liters/minutes | Standard Deviation 1.6 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Output Measurement at Over Time | 5 Years | 4.3 Liters/minutes | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Output Measurement at Over Time | 7 Years | 4.2 Liters/minutes | Standard Deviation 0.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Output Measurement at Over Time | 2 Years | 4.3 Liters/minutes | Standard Deviation 0.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Output Measurement at Over Time | 3 Years | 4.3 Liters/minutes | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Output Measurement at Over Time | 1 Year | 4.4 Liters/minutes | Standard Deviation 1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Output Measurement at Over Time | 6 Years | 4.2 Liters/minutes | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Output Measurement at Over Time | Discharge | 4.6 Liters/minutes | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Output Measurement at Over Time | 4 Years | 4.1 Liters/minutes | Standard Deviation 0.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Cardiac Output Measurement at Over Time | 3 months | 4.4 Liters/minutes | Standard Deviation 0.8 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Output Measurement at Over Time | 4 Years | 4.9 Liters/minutes | Standard Deviation 1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Output Measurement at Over Time | 1 Year | 4.9 Liters/minutes | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Output Measurement at Over Time | 7 Years | 5.0 Liters/minutes | Standard Deviation 1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Output Measurement at Over Time | 2 Years | 4.9 Liters/minutes | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Output Measurement at Over Time | 3 months | 5.0 Liters/minutes | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Output Measurement at Over Time | 5 Years | 4.8 Liters/minutes | Standard Deviation 1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Output Measurement at Over Time | 8 Years | 5.4 Liters/minutes | Standard Deviation 1.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Output Measurement at Over Time | 3 Years | 4.9 Liters/minutes | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Output Measurement at Over Time | 6 Years | 4.9 Liters/minutes | Standard Deviation 1.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Cardiac Output Measurement at Over Time | Discharge | 5.4 Liters/minutes | Standard Deviation 1.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Output Measurement at Over Time | 7 Years | 5.1 Liters/minutes | Standard Deviation 1.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Output Measurement at Over Time | Discharge | 5.6 Liters/minutes | Standard Deviation 1.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Output Measurement at Over Time | 3 months | 5.2 Liters/minutes | Standard Deviation 1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Output Measurement at Over Time | 1 Year | 5.1 Liters/minutes | Standard Deviation 1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Output Measurement at Over Time | 2 Years | 5.0 Liters/minutes | Standard Deviation 1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Output Measurement at Over Time | 3 Years | 5.1 Liters/minutes | Standard Deviation 1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Output Measurement at Over Time | 4 Years | 5.1 Liters/minutes | Standard Deviation 1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Output Measurement at Over Time | 5 Years | 5.0 Liters/minutes | Standard Deviation 1.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Output Measurement at Over Time | 6 Years | 5.0 Liters/minutes | Standard Deviation 1.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Cardiac Output Measurement at Over Time | 8 Years | 4.9 Liters/minutes | Standard Deviation 1.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Output Measurement at Over Time | 5 Years | 5.2 Liters/minutes | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Output Measurement at Over Time | 4 Years | 5.2 Liters/minutes | Standard Deviation 1.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Output Measurement at Over Time | 3 Years | 5.2 Liters/minutes | Standard Deviation 1.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Output Measurement at Over Time | 3 months | 5.4 Liters/minutes | Standard Deviation 1.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Output Measurement at Over Time | 7 Years | 5.0 Liters/minutes | Standard Deviation 0.9 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Output Measurement at Over Time | 2 Years | 5.3 Liters/minutes | Standard Deviation 1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Output Measurement at Over Time | 1 Year | 5.5 Liters/minutes | Standard Deviation 1.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Output Measurement at Over Time | Discharge | 5.9 Liters/minutes | Standard Deviation 1.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Output Measurement at Over Time | 8 Years | 5.5 Liters/minutes | Standard Deviation 1.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Cardiac Output Measurement at Over Time | 6 Years | 5.3 Liters/minutes | Standard Deviation 1.2 |
Secondary
Subject's Effective Orifice Area (EOA) Measurement Over Time
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time | 1 Year | 1.1 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time | Discharge | 1.1 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time | 4 Years | 1.2 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time | 3 months | 1.1 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time | 6 Years | 1.2 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time | 5 Years | 1.2 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time | 3 Years | 1.1 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time | 7 Years | 1.2 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time | 2 Years | 1.1 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area (EOA) Measurement Over Time | 8 Years | 1.1 Centimeters squared | Standard Deviation 0 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area (EOA) Measurement Over Time | 1 Year | 1.4 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area (EOA) Measurement Over Time | 3 months | 1.3 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area (EOA) Measurement Over Time | 2 Years | 1.4 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area (EOA) Measurement Over Time | Discharge | 1.3 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area (EOA) Measurement Over Time | 4 Years | 1.4 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area (EOA) Measurement Over Time | 7 Years | 1.4 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area (EOA) Measurement Over Time | 3 Years | 1.4 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area (EOA) Measurement Over Time | 5 Years | 1.4 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area (EOA) Measurement Over Time | 6 Years | 1.4 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area (EOA) Measurement Over Time | 8 Years | 1.4 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area (EOA) Measurement Over Time | 2 Years | 1.7 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area (EOA) Measurement Over Time | 5 Years | 1.7 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area (EOA) Measurement Over Time | 6 Years | 1.6 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area (EOA) Measurement Over Time | 7 Years | 1.6 Centimeters squared | Standard Deviation 0.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area (EOA) Measurement Over Time | 8 Years | 1.6 Centimeters squared | Standard Deviation 0.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area (EOA) Measurement Over Time | Discharge | 1.7 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area (EOA) Measurement Over Time | 3 months | 1.7 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area (EOA) Measurement Over Time | 1 Year | 1.7 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area (EOA) Measurement Over Time | 3 Years | 1.7 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area (EOA) Measurement Over Time | 4 Years | 1.7 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area (EOA) Measurement Over Time | 3 months | 1.9 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area (EOA) Measurement Over Time | 8 Years | 1.7 Centimeters squared | Standard Deviation 0.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area (EOA) Measurement Over Time | 1 Year | 1.9 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area (EOA) Measurement Over Time | 7 Years | 1.8 Centimeters squared | Standard Deviation 0.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area (EOA) Measurement Over Time | 2 Years | 1.9 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area (EOA) Measurement Over Time | 6 Years | 1.9 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area (EOA) Measurement Over Time | 4 Years | 1.9 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area (EOA) Measurement Over Time | 3 Years | 1.9 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area (EOA) Measurement Over Time | Discharge | 1.9 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area (EOA) Measurement Over Time | 5 Years | 1.8 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area (EOA) Measurement Over Time | 2 Years | 2.2 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area (EOA) Measurement Over Time | 3 months | 2.2 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area (EOA) Measurement Over Time | 3 Years | 2.1 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area (EOA) Measurement Over Time | 7 Years | 2.1 Centimeters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area (EOA) Measurement Over Time | 4 Years | 2.1 Centimeters squared | Standard Deviation 0.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area (EOA) Measurement Over Time | 5 Years | 2.1 Centimeters squared | Standard Deviation 0.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area (EOA) Measurement Over Time | 1 Year | 2.2 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area (EOA) Measurement Over Time | Discharge | 2.2 Centimeters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area (EOA) Measurement Over Time | 6 Years | 2.0 Centimeters squared | Standard Deviation 0.3 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area (EOA) Measurement Over Time | 8 Years | 2.1 Centimeters squared | Standard Deviation 0.1 |
Secondary
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 3 Years | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 4 Years | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 8 Years | 0.6 centimeters squared/meters squared | Standard Deviation 0 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 3 months | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | Discharge | 0.6 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 7 Years | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 1 Year | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 6 Years | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 2 Years | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 5 Years | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 7 Years | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 3 Years | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 2 Years | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 4 Years | 0.8 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | Discharge | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 8 Years | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 5 Years | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 1 Year | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 3 months | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 6 Years | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 1 Year | 0.8 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | Discharge | 0.8 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 3 months | 0.8 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 2 Years | 0.8 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 3 Years | 0.8 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 4 Years | 0.8 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 5 Years | 0.8 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 6 Years | 0.8 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 7 Years | 0.8 centimeters squared/meters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 8 Years | 0.8 centimeters squared/meters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | Discharge | 0.9 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 3 months | 0.9 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 8 Years | 0.8 centimeters squared/meters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 7 Years | 0.9 centimeters squared/meters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 1 Year | 0.9 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 5 Years | 0.9 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 3 Years | 0.9 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 6 Years | 0.9 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 4 Years | 0.9 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 2 Years | 0.9 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 4 Years | 1.0 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 5 Years | 1.0 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 1 Year | 1.0 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 8 Years | 1.0 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 6 Years | 0.9 centimeters squared/meters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 3 months | 1.0 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 7 Years | 1.0 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 3 Years | 1.0 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | Discharge | 1.0 centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 2 Years | 1.0 centimeters squared/meters squared | Standard Deviation 0.1 |
Secondary
Subject's New York Heart Association (NYHA) Classification Over Time
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
Time frame: Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's New York Heart Association (NYHA) Classification Over Time | Baseline | 135 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's New York Heart Association (NYHA) Classification Over Time | 8 Years | 28 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's New York Heart Association (NYHA) Classification Over Time | 1 Year | 648 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's New York Heart Association (NYHA) Classification Over Time | 3 months | 671 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's New York Heart Association (NYHA) Classification Over Time | 6 Years | 251 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's New York Heart Association (NYHA) Classification Over Time | 2 Years | 606 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's New York Heart Association (NYHA) Classification Over Time | 5 Years | 420 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's New York Heart Association (NYHA) Classification Over Time | 3 Years | 551 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's New York Heart Association (NYHA) Classification Over Time | 7 Years | 109 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's New York Heart Association (NYHA) Classification Over Time | 4 Years | 487 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's New York Heart Association (NYHA) Classification Over Time | 3 Years | 122 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's New York Heart Association (NYHA) Classification Over Time | 5 Years | 109 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's New York Heart Association (NYHA) Classification Over Time | 7 Years | 31 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's New York Heart Association (NYHA) Classification Over Time | 6 Years | 63 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's New York Heart Association (NYHA) Classification Over Time | 8 Years | 5 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's New York Heart Association (NYHA) Classification Over Time | 2 Years | 133 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's New York Heart Association (NYHA) Classification Over Time | 3 months | 148 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's New York Heart Association (NYHA) Classification Over Time | 1 Year | 145 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's New York Heart Association (NYHA) Classification Over Time | 4 Years | 123 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's New York Heart Association (NYHA) Classification Over Time | Baseline | 468 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's New York Heart Association (NYHA) Classification Over Time | Baseline | 264 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's New York Heart Association (NYHA) Classification Over Time | 3 months | 20 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's New York Heart Association (NYHA) Classification Over Time | 1 Year | 18 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's New York Heart Association (NYHA) Classification Over Time | 2 Years | 22 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's New York Heart Association (NYHA) Classification Over Time | 3 Years | 19 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's New York Heart Association (NYHA) Classification Over Time | 7 Years | 4 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's New York Heart Association (NYHA) Classification Over Time | 8 Years | 1 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's New York Heart Association (NYHA) Classification Over Time | 4 Years | 21 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's New York Heart Association (NYHA) Classification Over Time | 5 Years | 14 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's New York Heart Association (NYHA) Classification Over Time | 6 Years | 14 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's New York Heart Association (NYHA) Classification Over Time | 6 Years | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's New York Heart Association (NYHA) Classification Over Time | 2 Years | 3 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's New York Heart Association (NYHA) Classification Over Time | 7 Years | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's New York Heart Association (NYHA) Classification Over Time | 5 Years | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's New York Heart Association (NYHA) Classification Over Time | 1 Year | 3 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's New York Heart Association (NYHA) Classification Over Time | 3 months | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's New York Heart Association (NYHA) Classification Over Time | Baseline | 15 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's New York Heart Association (NYHA) Classification Over Time | 8 Years | 0 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's New York Heart Association (NYHA) Classification Over Time | 4 Years | 3 Participants |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's New York Heart Association (NYHA) Classification Over Time | 3 Years | 1 Participants |
Secondary
Subject's Performance Index Measurement Over Time
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. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Performance Index Measurement Over Time | 1 Year | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Performance Index Measurement Over Time | 3 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Performance Index Measurement Over Time | 7 Years | 1.0 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Performance Index Measurement Over Time | 3 months | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Performance Index Measurement Over Time | 6 Years | 1.0 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Performance Index Measurement Over Time | 5 Years | 1.0 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Performance Index Measurement Over Time | 8 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Performance Index Measurement Over Time | 2 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Performance Index Measurement Over Time | Discharge | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Performance Index Measurement Over Time | 4 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Performance Index Measurement Over Time | Discharge | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Performance Index Measurement Over Time | 1 Year | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Performance Index Measurement Over Time | 3 months | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Performance Index Measurement Over Time | 4 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Performance Index Measurement Over Time | 3 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Performance Index Measurement Over Time | 7 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Performance Index Measurement Over Time | 5 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Performance Index Measurement Over Time | 8 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Performance Index Measurement Over Time | 2 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class II | Subject's Performance Index Measurement Over Time | 6 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Performance Index Measurement Over Time | 4 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Performance Index Measurement Over Time | 3 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Performance Index Measurement Over Time | 5 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Performance Index Measurement Over Time | 6 Years | 0.8 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Performance Index Measurement Over Time | Discharge | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Performance Index Measurement Over Time | 3 months | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Performance Index Measurement Over Time | 1 Year | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Performance Index Measurement Over Time | 2 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Performance Index Measurement Over Time | 7 Years | 0.8 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III | Subject's Performance Index Measurement Over Time | 8 Years | 0.8 Centimeters squared/meters squared | Standard Deviation 0.2 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Performance Index Measurement Over Time | 3 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Performance Index Measurement Over Time | 1 Year | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Performance Index Measurement Over Time | 6 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Performance Index Measurement Over Time | 5 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Performance Index Measurement Over Time | 2 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Performance Index Measurement Over Time | 4 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Performance Index Measurement Over Time | 8 Years | 0.8 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Performance Index Measurement Over Time | 7 Years | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Performance Index Measurement Over Time | 3 months | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subject's Performance Index Measurement Over Time | Discharge | 0.9 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Performance Index Measurement Over Time | 4 Years | 0.8 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Performance Index Measurement Over Time | 3 Years | 0.8 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Performance Index Measurement Over Time | 1 Year | 0.8 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Performance Index Measurement Over Time | Discharge | 0.8 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Performance Index Measurement Over Time | 5 Years | 0.8 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Performance Index Measurement Over Time | 6 Years | 0.8 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Performance Index Measurement Over Time | 3 months | 0.8 Centimeters squared/meters squared | Standard Deviation 0.1 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Performance Index Measurement Over Time | 8 Years | 0.8 Centimeters squared/meters squared | Standard Deviation 0 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Performance Index Measurement Over Time | 7 Years | 0.8 Centimeters squared/meters squared | Standard Deviation 0 |
| Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subject's Performance Index Measurement Over Time | 2 Years | 0.8 Centimeters squared/meters squared | Standard Deviation 0.1 |
Other Pre-specified
Subject's Average Hematocrit Percentage Over Time
Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hematocrit Percentage Over Time | 3 Years | 40.42 Percentage of RBC | Standard Deviation 4.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hematocrit Percentage Over Time | 4 Years | 40.40 Percentage of RBC | Standard Deviation 4.2 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hematocrit Percentage Over Time | Discharge | 29.94 Percentage of RBC | Standard Deviation 4 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hematocrit Percentage Over Time | 3 months | 39.28 Percentage of RBC | Standard Deviation 4.2 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hematocrit Percentage Over Time | 1 Year | 40.25 Percentage of RBC | Standard Deviation 4.4 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hematocrit Percentage Over Time | 2 Years | 40.30 Percentage of RBC | Standard Deviation 4.4 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hematocrit Percentage Over Time | 5 Years | 40.66 Percentage of RBC | Standard Deviation 4.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hematocrit Percentage Over Time | 6 Years | 40.41 Percentage of RBC | Standard Deviation 4.4 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hematocrit Percentage Over Time | 7 Years | 40.00 Percentage of RBC | Standard Deviation 4.8 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hematocrit Percentage Over Time | 8 Years | 39.31 Percentage of RBC | Standard Deviation 5.4 |
Other Pre-specified
Subject's Average Hemoglobin Percentage Over Time
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hemoglobin Percentage Over Time | 2 Years | 13.37 g/dL | Standard Deviation 1.6 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hemoglobin Percentage Over Time | 8 Years | 12.87 g/dL | Standard Deviation 1.9 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hemoglobin Percentage Over Time | 3 Years | 13.42 g/dL | Standard Deviation 1.6 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hemoglobin Percentage Over Time | Discharge | 9.95 g/dL | Standard Deviation 1.4 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hemoglobin Percentage Over Time | 3 months | 12.82 g/dL | Standard Deviation 1.6 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hemoglobin Percentage Over Time | 1 Year | 13.33 g/dL | Standard Deviation 1.6 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hemoglobin Percentage Over Time | 4 Years | 13.39 g/dL | Standard Deviation 1.6 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hemoglobin Percentage Over Time | 5 Years | 13.22 g/dL | Standard Deviation 2.2 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hemoglobin Percentage Over Time | 6 Years | 13.20 g/dL | Standard Deviation 1.8 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Hemoglobin Percentage Over Time | 7 Years | 13.10 g/dL | Standard Deviation 1.8 |
Other Pre-specified
Subject's Average Plasma Free Hemoglobin Over Time
Laboratory Analysis of Plasma Free Hemoglobin (Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Plasma Free Hemoglobin Over Time | Discharge | 11.89 mg/dL | Standard Deviation 14.6 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Plasma Free Hemoglobin Over Time | 3 months | 13.12 mg/dL | Standard Deviation 13.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Plasma Free Hemoglobin Over Time | 1 Year | 12.08 mg/dL | Standard Deviation 12.9 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Plasma Free Hemoglobin Over Time | 2 Years | 12.06 mg/dL | Standard Deviation 13.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Plasma Free Hemoglobin Over Time | 3 Years | 11.90 mg/dL | Standard Deviation 15.7 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Plasma Free Hemoglobin Over Time | 4 Years | 11.88 mg/dL | Standard Deviation 14.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Plasma Free Hemoglobin Over Time | 5 Years | 12.73 mg/dL | Standard Deviation 16.9 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Plasma Free Hemoglobin Over Time | 6 Years | 16.32 mg/dL | Standard Deviation 14.4 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Plasma Free Hemoglobin Over Time | 7 Years | 18.43 mg/dL | Standard Deviation 14.9 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Plasma Free Hemoglobin Over Time | 8 Years | 22.61 mg/dL | Standard Deviation 11.4 |
Other Pre-specified
Subject's Average Red Blood Cell Count Over Time
The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10\^6 cells/microliters and for men is 4.7 to 6.1 10\^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range can indicate something is wrong.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Red Blood Cell Count Over Time | Discharge | 3.31 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Red Blood Cell Count Over Time | 3 months | 4.51 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Red Blood Cell Count Over Time | 1 Year | 4.46 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Red Blood Cell Count Over Time | 2 Years | 4.45 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Red Blood Cell Count Over Time | 3 Years | 4.46 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Red Blood Cell Count Over Time | 6 Years | 4.38 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Red Blood Cell Count Over Time | 7 Years | 4.33 10^6 cells/microliters | Standard Deviation 0.6 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Red Blood Cell Count Over Time | 8 Years | 4.28 10^6 cells/microliters | Standard Deviation 0.7 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Red Blood Cell Count Over Time | 4 Years | 4.44 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Red Blood Cell Count Over Time | 5 Years | 4.43 10^6 cells/microliters | Standard Deviation 0.6 |
Other Pre-specified
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status.
Time frame: Baseline and one year follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available at both the baseline and 1 year follow-up visits. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Mental Health - Baseline | 51.3 Units on a scale | Standard Deviation 9.9 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Mental Health - 1 year follow-up | 54.3 Units on a scale | Standard Deviation 8.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Physical Health - Baseline | 41.8 Units on a scale | Standard Deviation 10.2 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Physical Health - 1 year follow-up | 47.6 Units on a scale | Standard Deviation 9.7 |
Other Pre-specified
Subject's Average White Blood Cell Count Over Time
Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10 10\^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average White Blood Cell Count Over Time | 3 months | 7.27 10^3 cells/microliters | Standard Deviation 2.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average White Blood Cell Count Over Time | 7 Years | 8.05 10^3 cells/microliters | Standard Deviation 9.8 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average White Blood Cell Count Over Time | Discharge | 9.54 10^3 cells/microliters | Standard Deviation 3 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average White Blood Cell Count Over Time | 1 Year | 7.31 10^3 cells/microliters | Standard Deviation 2.8 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average White Blood Cell Count Over Time | 2 Years | 7.47 10^3 cells/microliters | Standard Deviation 4.5 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average White Blood Cell Count Over Time | 3 Years | 7.47 10^3 cells/microliters | Standard Deviation 5.7 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average White Blood Cell Count Over Time | 4 Years | 7.41 10^3 cells/microliters | Standard Deviation 3 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average White Blood Cell Count Over Time | 5 Years | 7.37 10^3 cells/microliters | Standard Deviation 3.6 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average White Blood Cell Count Over Time | 6 Years | 7.47 10^3 cells/microliters | Standard Deviation 6.1 |
| Edwards INTUITY Surgical Aortic Heart Valve | Subject's Average White Blood Cell Count Over Time | 8 Years | 14.0 10^3 cells/microliters | Standard Deviation 36.8 |