Aortic Stenosis, Aortic Valve Disease
Conditions
Keywords
Aortic Valve Replacement, Aortic Stenosis, EDWARDS INTUITY Elite, Rapid deployment valves
Brief summary
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.
Detailed description
Aortic valve replacement with mechanical or biological heart valves is the treatment of choice for aortic valve stenosis. Over the past several years, life expectancy has increased in industrial nations, but this has been accompanied by a rising rate of elderly patients with multiple illnesses. Aortic stenosis remains the most common cause of adult valvular heart disease, the prevalence increasing with age. Average survival of patients treated conservatively has historically been reported as 2-5 years from the onset of symptoms. More recent studies have confirmed the dismal prognosis of severe aortic stenosis. Advanced age, reduced left-ventricular ejection fraction, congestive heart failure and renal insufficiency appear to be independent predictors of reduced survival. Asymptomatic patients with very severe aortic stenosis also share a poor prognosis with a high event rate and a risk of rapid functional deterioration. Early surgery offers a therapeutic option to improve clinical outcomes via decreasing cardiac mortality and improving symptoms. Bioprostheses offer several advantages over mechanical bioprostheses, the most important being freedom from anticoagulation with a low rate of thromboembolic accidents. In response to clinical need and in support of advances in minimally invasive surgical approaches to conventional AVR, Edwards Lifesciences developed the EDWARDS INTUITY Elite Valve System to achieve clinical benefits by reducing cardiopulmonary bypass and cross clamp times, while facilitating a less invasive approach to aortic valve replacement. The system includes the EDWARDS INTUITY Elite Valve System, Model 8300AB and the EDWARDS INTUITY Elite Delivery System, Model 8300DB; the valve is based on prior heart valve designs which have a long history of safety and effectiveness and have incorporated additional features designed to improve patient outcomes and safety. With only 3 guiding sutures and secure balloon expandable frame, the EDWARDS INTUITY Elite Valve system is well suited for smaller incisions and tight access, with an emphasis on procedural efficiency within existing operating suite of the surgeon.
Interventions
None listed
Sponsors
Edwards Lifesciences
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is 18 years or older 2. Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines. 3. Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy. 4. Surgery is intended to be completed with an EDWARDS INTUITY Elite Heart Valve. 5. Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed. 6. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.
Exclusion criteria
1. Subject is diagnosed with pure aortic insufficiency. 2. Subject requires multiple valve replacement/repair 3. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve. 4. Subject has severe ventricular dysfunction defined as LVEF \< 25%. 5. Subject has a history of active endocarditis and/or myocarditis ≤ 3 months before the intended treatment/scheduled surgery. 6. Subject has had an acute MI ≤ 3 months before the intended treatment. 7. Subject had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery. 8. Subject is oxygen or ventilator dependent. 9. Subject has life expectancy \< 12 months. 10. Female subject is pregnant or lactating. 11. Subject with documented leukopenia (WBC \< 3.5x 103/μL), anemia (Hb \< 10.0 gm/dL or \< 6.2 mmol/L), thrombocytopenia (platelet count \< 100x 103/mL), or history of bleeding diathesis or coagulopathy. 12. Subject has renal insufficiency as determined by Serum creatinine ≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis. 13. Subject is currently participating in an investigational drug or device trial for which follow-up has not yet been completed. 14. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition. 15. Aneurysm of the aortic root and/or ascending aorta Intra-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Average Time Spent on Cardiopulmonary Cross Clamp | At time of surgery; an average of 1 hour | Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge and 6 Months | Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome. |
| Subject's Average Mean Gradient Measurements Over Time. | Baseline, Discharge and 6 months | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. |
| Subject's Average Peak Gradients Measurements Over Time. | Baseline, Discharge and 6 months | Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. |
| Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | Discharge and 6 months | Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. |
| Subject's Average Performance Index Measurements Over Time. | Baseline, Discharge and 6 months | 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 pre-implant orifice area. Effective orifice area is evaluated by echocardiography over time. |
| Subject's Average Cardiac Output Over Time | Baseline, Discharge and 6 months | The amount of blood the heart pumps through the circulatory system in a minute. |
| Subject's Average Cardiac Index | Discharge and 6 months | A measure of cardiac output per square meter of body surface area |
| Subject's Amount of Paravalvular Leak Over Time. | Discharge and 6 months | Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome. |
| Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Baseline, Discharge and 6 months | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. |
| Subject's Average Time Spent on Cardiopulmonary Bypass. | At time of surgery; an average of 1.5 hours | Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery. |
| Device Technical Success Rate | At time of surgery | The successful delivery and deployment of the EDWARDS INTUITY Elite valve and delivery system, and the subject leaving the operating room with valve in place. |
| First Attempt Success Rate | At time of surgery | The successful delivery and deployment of the valve and delivery system during the first attempt, and subject leaving the operating room with EDWARDS INTUITY Elite valve in place. |
| Procedural Success | Day of procedure and events occurring within 10 days of procedure | Procedural success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker (with baseline sinus rhythm and no other conduction issues), or subject death, within discharge or 10 days post index procedure whichever comes first. |
| Subject's Average Health Care Utilization | Day of surgical procedure through discharge from the hospital, an average of 3 days and 10 days respectively. | The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Events occuring >= 31 days and up through 6 months | Number of late adverse events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). |
| Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 6 months compared to baseline | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. |
| Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time | Baseline and 6 months | The EuroQol-5 Dimension (EQ-5D) is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. |
| Subject's Average Fitness for Hospital Discharge | Day of surgical procedure through discharge from the hospital; an average of 7 days | Considered as the day at which the patient was fit for hospital discharge. |
| Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Events occurring within 30 days of procedure | Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100 |
| Subject's Average SF-36 Mental Health Summary | Baseline and 6 months | The Medical Outcomes Study Short-Form 36 - Mental Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status. |
| Subject's Average SF-36 Physical Health Summary | Baseline and 6 months | The Medical Outcomes Study Short-Form 36 - Physical Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status. |
Countries
Austria, Denmark, France, Germany, Italy, Luxembourg, Netherlands, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Per Protocol Cohort The per protocol cohort will consist of all enrolled patients that leave the operating room with the registry valve in place and had an AVR MIS surgery procedure. | 276 |
| Total | 276 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 10 |
| Overall Study | Device Explanted | 1 |
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | MIS Approach was not used | 2 |
| Overall Study | Missing Exit Form | 1 |
| Overall Study | Not Implanted with Study Device | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Per Protocol Cohort | — |
|---|---|---|
| Age, Continuous | 73.7 years STANDARD_DEVIATION 6.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 142 Participants | — |
| Sex: Female, Male Male | 134 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 10 / 280 |
| other Total, other adverse events | 155 / 280 |
| serious Total, serious adverse events | 108 / 280 |
Outcome results
Primary
Subject's Average Time Spent on Cardiopulmonary Cross Clamp
Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.
Time frame: At time of surgery; an average of 1 hour
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Average Time Spent on Cardiopulmonary Cross Clamp | Partial Sternotomy | 49.9 minutes | Standard Deviation 14.7 |
| Per Protocol Cohort | Subject's Average Time Spent on Cardiopulmonary Cross Clamp | Right Thoracotomy | 65.2 minutes | Standard Deviation 18.2 |
| Per Protocol Cohort | Subject's Average Time Spent on Cardiopulmonary Cross Clamp | All | 51.9 minutes | Standard Deviation 16 |
Secondary
Device Technical Success Rate
The successful delivery and deployment of the EDWARDS INTUITY Elite valve and delivery system, and the subject leaving the operating room with valve in place.
Time frame: At time of surgery
Population: The outcome is reported for subjects where data is available. Analysis is based on the enrolled cohort.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Per Protocol Cohort | Device Technical Success Rate | 276 Participants |
Secondary
First Attempt Success Rate
The successful delivery and deployment of the valve and delivery system during the first attempt, and subject leaving the operating room with EDWARDS INTUITY Elite valve in place.
Time frame: At time of surgery
Population: The outcome is reported for subjects where data is available. Analysis is based on the enrolled cohort.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Per Protocol Cohort | First Attempt Success Rate | 270 Participants |
Secondary
Procedural Success
Procedural success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker (with baseline sinus rhythm and no other conduction issues), or subject death, within discharge or 10 days post index procedure whichever comes first.
Time frame: Day of procedure and events occurring within 10 days of procedure
Population: The outcome is reported for subjects where data is available. Analysis is based on the enrolled cohort.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Per Protocol Cohort | Procedural Success | 274 Participants |
Secondary
Subject's Amount of Aortic Valvular Regurgitation Over Time.
Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Time frame: Discharge and 6 Months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +1 Trivial/Trace | 5 Participants |
| Per Protocol Cohort | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +2 Mild | 0 Participants |
| Per Protocol Cohort | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +2 Mild | 0 Participants |
| Per Protocol Cohort | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +4 Severe | 0 Participants |
| Per Protocol Cohort | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | 0 None | 14 Participants |
| Per Protocol Cohort | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | 0 None | 15 Participants |
| Per Protocol Cohort | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +3 Moderate | 0 Participants |
| Per Protocol Cohort | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +1 Trivial/Trace | 6 Participants |
| Per Protocol Cohort | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +3 Moderate | 0 Participants |
| Per Protocol Cohort | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +4 Severe | 0 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | 0 None | 54 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +4 Severe | 0 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +1 Trivial/Trace | 7 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | 0 None | 61 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +2 Mild | 0 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +2 Mild | 0 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +4 Severe | 0 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +1 Trivial/Trace | 8 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +1 Trivial/Trace | 8 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | 0 None | 48 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +1 Trivial/Trace | 3 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +2 Mild | 0 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +4 Severe | 0 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | 0 None | 46 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +2 Mild | 0 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +4 Severe | 0 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | 0 None | 40 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +4 Severe | 0 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +2 Mild | 0 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +4 Severe | 0 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +1 Trivial/Trace | 11 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +2 Mild | 0 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +1 Trivial/Trace | 5 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | 0 None | 40 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | 0 None | 13 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +2 Mild | 0 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +1 Trivial/Trace | 3 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +1 Trivial/Trace | 1 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +4 Severe | 0 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +2 Mild | 0 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | 0 None | 14 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +4 Severe | 0 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +1 Trivial/Trace | 27 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +2 Mild | 0 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +3 Moderate | 0 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +4 Severe | 0 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +1 Trivial/Trace | 30 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | +3 Moderate | 0 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | 0 None | 167 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +2 Mild | 0 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Discharge | 0 None | 178 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Aortic Valvular Regurgitation Over Time. | 6 months | +4 Severe | 0 Participants |
Secondary
Subject's Amount of Paravalvular Leak Over Time.
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Time frame: Discharge and 6 months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +3 Moderate | 0 Participants |
| Per Protocol Cohort | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +2 Mild | 0 Participants |
| Per Protocol Cohort | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +4 Severe | 0 Participants |
| Per Protocol Cohort | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +3 Moderate | 0 Participants |
| Per Protocol Cohort | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +2 Mild | 1 Participants |
| Per Protocol Cohort | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +1 Trivial/Trace | 1 Participants |
| Per Protocol Cohort | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +1 Trivial/Trace | 1 Participants |
| Per Protocol Cohort | Subject's Amount of Paravalvular Leak Over Time. | Discharge | 0 None | 19 Participants |
| Per Protocol Cohort | Subject's Amount of Paravalvular Leak Over Time. | 6 months | 0 None | 18 Participants |
| Per Protocol Cohort | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +4 Severe | 0 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +1 Trivial/Trace | 6 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | 0 None | 59 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +2 Mild | 3 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +4 Severe | 0 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | 0 None | 55 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +1 Trivial/Trace | 6 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +2 Mild | 1 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 21mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +4 Severe | 0 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +2 Mild | 0 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | 0 None | 45 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +4 Severe | 0 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +2 Mild | 0 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +1 Trivial/Trace | 5 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | 0 None | 49 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +4 Severe | 0 Participants |
| Per Protocol Cohort - 23mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +1 Trivial/Trace | 4 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +1 Trivial/Trace | 4 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +2 Mild | 1 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +1 Trivial/Trace | 5 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +4 Severe | 0 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | 0 None | 45 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | 0 None | 40 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +4 Severe | 0 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +3 Moderate | 0 Participants |
| Per Protocol Cohort - 25mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +2 Mild | 1 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +1 Trivial/Trace | 0 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +3 Moderate | 1 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +4 Severe | 0 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | 0 None | 15 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | 0 None | 14 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +2 Mild | 0 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +4 Severe | 0 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +3 Moderate | 1 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +2 Mild | 0 Participants |
| Per Protocol Cohort - 27mm | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +1 Trivial/Trace | 0 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Paravalvular Leak Over Time. | 6 months | 0 None | 177 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +4 Severe | 0 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +1 Trivial/Trace | 17 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +2 Mild | 4 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +4 Severe | 0 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +1 Trivial/Trace | 15 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Paravalvular Leak Over Time. | Discharge | +3 Moderate | 1 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +2 Mild | 3 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Paravalvular Leak Over Time. | Discharge | 0 None | 182 Participants |
| Per Protocol Cohort - Total | Subject's Amount of Paravalvular Leak Over Time. | 6 months | +3 Moderate | 1 Participants |
Secondary
Subject's Average Cardiac Index
A measure of cardiac output per square meter of body surface area
Time frame: Discharge and 6 months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Average Cardiac Index | Discharge | 2.3 L/min/meters squared | Standard Deviation 0.6 |
| Per Protocol Cohort | Subject's Average Cardiac Index | 6 months | 2.4 L/min/meters squared | Standard Deviation 0.3 |
| Per Protocol Cohort - 21mm | Subject's Average Cardiac Index | Discharge | 2.7 L/min/meters squared | Standard Deviation 0.8 |
| Per Protocol Cohort - 21mm | Subject's Average Cardiac Index | 6 months | 2.5 L/min/meters squared | Standard Deviation 0.6 |
| Per Protocol Cohort - 23mm | Subject's Average Cardiac Index | Discharge | 2.8 L/min/meters squared | Standard Deviation 0.8 |
| Per Protocol Cohort - 23mm | Subject's Average Cardiac Index | 6 months | 2.6 L/min/meters squared | Standard Deviation 0.9 |
| Per Protocol Cohort - 25mm | Subject's Average Cardiac Index | Discharge | 2.8 L/min/meters squared | Standard Deviation 0.8 |
| Per Protocol Cohort - 25mm | Subject's Average Cardiac Index | 6 months | 2.6 L/min/meters squared | Standard Deviation 0.5 |
| Per Protocol Cohort - 27mm | Subject's Average Cardiac Index | Discharge | 2.4 L/min/meters squared | Standard Deviation 0.7 |
| Per Protocol Cohort - 27mm | Subject's Average Cardiac Index | 6 months | 2.6 L/min/meters squared | Standard Deviation 0.6 |
| Per Protocol Cohort - Total | Subject's Average Cardiac Index | Discharge | 2.7 L/min/meters squared | Standard Deviation 0.8 |
| Per Protocol Cohort - Total | Subject's Average Cardiac Index | 6 months | 2.6 L/min/meters squared | Standard Deviation 0.7 |
Secondary
Subject's Average Cardiac Output Over Time
The amount of blood the heart pumps through the circulatory system in a minute.
Time frame: Baseline, Discharge and 6 months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Average Cardiac Output Over Time | Discharge | 4.0 liters per minute | Standard Deviation 1.1 |
| Per Protocol Cohort | Subject's Average Cardiac Output Over Time | Baseline | 4.8 liters per minute | Standard Deviation 1.2 |
| Per Protocol Cohort | Subject's Average Cardiac Output Over Time | 6 months | 4.1 liters per minute | Standard Deviation 0.9 |
| Per Protocol Cohort - 21mm | Subject's Average Cardiac Output Over Time | Discharge | 4.9 liters per minute | Standard Deviation 1.7 |
| Per Protocol Cohort - 21mm | Subject's Average Cardiac Output Over Time | Baseline | 5.3 liters per minute | Standard Deviation 1.5 |
| Per Protocol Cohort - 21mm | Subject's Average Cardiac Output Over Time | 6 months | 4.5 liters per minute | Standard Deviation 1 |
| Per Protocol Cohort - 23mm | Subject's Average Cardiac Output Over Time | Discharge | 5.4 liters per minute | Standard Deviation 1.5 |
| Per Protocol Cohort - 23mm | Subject's Average Cardiac Output Over Time | Baseline | 5.4 liters per minute | Standard Deviation 1.3 |
| Per Protocol Cohort - 23mm | Subject's Average Cardiac Output Over Time | 6 months | 4.8 liters per minute | Standard Deviation 1.4 |
| Per Protocol Cohort - 25mm | Subject's Average Cardiac Output Over Time | Discharge | 5.7 liters per minute | Standard Deviation 1.6 |
| Per Protocol Cohort - 25mm | Subject's Average Cardiac Output Over Time | Baseline | 6.1 liters per minute | Standard Deviation 1.8 |
| Per Protocol Cohort - 25mm | Subject's Average Cardiac Output Over Time | 6 months | 5.2 liters per minute | Standard Deviation 1 |
| Per Protocol Cohort - 27mm | Subject's Average Cardiac Output Over Time | Discharge | 5.0 liters per minute | Standard Deviation 1.4 |
| Per Protocol Cohort - 27mm | Subject's Average Cardiac Output Over Time | Baseline | 6.2 liters per minute | Standard Deviation 1.5 |
| Per Protocol Cohort - 27mm | Subject's Average Cardiac Output Over Time | 6 months | 5.4 liters per minute | Standard Deviation 1.6 |
| Per Protocol Cohort - Total | Subject's Average Cardiac Output Over Time | Baseline | 5.5 liters per minute | Standard Deviation 1.5 |
| Per Protocol Cohort - Total | Subject's Average Cardiac Output Over Time | 6 months | 4.8 liters per minute | Standard Deviation 1.2 |
| Per Protocol Cohort - Total | Subject's Average Cardiac Output Over Time | Discharge | 5.1 liters per minute | Standard Deviation 1.6 |
Secondary
Subject's Average Effective Orifice Area (EOA) Measurements Over Time
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Time frame: Baseline, Discharge and 6 months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Discharge | 1.2 centimeters squared | Standard Deviation 0.3 |
| Per Protocol Cohort | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Baseline | 0.7 centimeters squared | Standard Deviation 0.2 |
| Per Protocol Cohort | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | 6 months | 1.2 centimeters squared | Standard Deviation 0.3 |
| Per Protocol Cohort - 21mm | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Discharge | 1.5 centimeters squared | Standard Deviation 0.6 |
| Per Protocol Cohort - 21mm | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Baseline | 0.8 centimeters squared | Standard Deviation 0.3 |
| Per Protocol Cohort - 21mm | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | 6 months | 1.5 centimeters squared | Standard Deviation 0.4 |
| Per Protocol Cohort - 23mm | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Discharge | 1.9 centimeters squared | Standard Deviation 0.6 |
| Per Protocol Cohort - 23mm | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Baseline | 0.8 centimeters squared | Standard Deviation 0.2 |
| Per Protocol Cohort - 23mm | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | 6 months | 1.9 centimeters squared | Standard Deviation 0.5 |
| Per Protocol Cohort - 25mm | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Discharge | 2.0 centimeters squared | Standard Deviation 0.6 |
| Per Protocol Cohort - 25mm | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Baseline | 0.9 centimeters squared | Standard Deviation 0.2 |
| Per Protocol Cohort - 25mm | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | 6 months | 2.1 centimeters squared | Standard Deviation 0.5 |
| Per Protocol Cohort - 27mm | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Discharge | 2.3 centimeters squared | Standard Deviation 0.7 |
| Per Protocol Cohort - 27mm | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Baseline | 1.0 centimeters squared | Standard Deviation 0.2 |
| Per Protocol Cohort - 27mm | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | 6 months | 2.5 centimeters squared | Standard Deviation 0.6 |
| Per Protocol Cohort - Total | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Baseline | 0.8 centimeters squared | Standard Deviation 0.3 |
| Per Protocol Cohort - Total | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | 6 months | 1.8 centimeters squared | Standard Deviation 0.6 |
| Per Protocol Cohort - Total | Subject's Average Effective Orifice Area (EOA) Measurements Over Time | Discharge | 1.8 centimeters squared | Standard Deviation 0.6 |
Secondary
Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time.
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
Time frame: Discharge and 6 months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | Discharge | 0.7 centimeters squared/meters squared | Standard Deviation 0.2 |
| Per Protocol Cohort | Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | 6 months | 0.7 centimeters squared/meters squared | Standard Deviation 0.1 |
| Per Protocol Cohort - 21mm | Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | Discharge | 0.9 centimeters squared/meters squared | Standard Deviation 0.4 |
| Per Protocol Cohort - 21mm | Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | 6 months | 0.8 centimeters squared/meters squared | Standard Deviation 0.2 |
| Per Protocol Cohort - 23mm | Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | Discharge | 1.0 centimeters squared/meters squared | Standard Deviation 0.3 |
| Per Protocol Cohort - 23mm | Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | 6 months | 1.0 centimeters squared/meters squared | Standard Deviation 0.3 |
| Per Protocol Cohort - 25mm | Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | Discharge | 1.0 centimeters squared/meters squared | Standard Deviation 0.3 |
| Per Protocol Cohort - 25mm | Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | 6 months | 1.1 centimeters squared/meters squared | Standard Deviation 0.3 |
| Per Protocol Cohort - 27mm | Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | Discharge | 1.1 centimeters squared/meters squared | Standard Deviation 0.4 |
| Per Protocol Cohort - 27mm | Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | 6 months | 1.2 centimeters squared/meters squared | Standard Deviation 0.3 |
| Per Protocol Cohort - Total | Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | Discharge | 0.9 centimeters squared/meters squared | Standard Deviation 0.3 |
| Per Protocol Cohort - Total | Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. | 6 months | 0.9 centimeters squared/meters squared | Standard Deviation 0.3 |
Secondary
Subject's Average Health Care Utilization
The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure.
Time frame: Day of surgical procedure through discharge from the hospital, an average of 3 days and 10 days respectively.
Population: The outcome is reported for subjects where data is available. Analysis is based on the enrolled cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Average Health Care Utilization | ICU Length of Stay | 3.3 days | Standard Deviation 7.2 |
| Per Protocol Cohort | Subject's Average Health Care Utilization | Hospital Length of Stay | 9.5 days | Standard Deviation 6.7 |
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. Mean gradient values depend on the size and type of valve.
Time frame: Baseline, Discharge and 6 months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Average Mean Gradient Measurements Over Time. | 6 months | 11.7 mmHg | Standard Deviation 4.4 |
| Per Protocol Cohort | Subject's Average Mean Gradient Measurements Over Time. | Discharge | 15.0 mmHg | Standard Deviation 5.6 |
| Per Protocol Cohort | Subject's Average Mean Gradient Measurements Over Time. | Baseline | 50 mmHg | Standard Deviation 18.1 |
| Per Protocol Cohort - 21mm | Subject's Average Mean Gradient Measurements Over Time. | Discharge | 12.8 mmHg | Standard Deviation 5 |
| Per Protocol Cohort - 21mm | Subject's Average Mean Gradient Measurements Over Time. | Baseline | 46.6 mmHg | Standard Deviation 13.7 |
| Per Protocol Cohort - 21mm | Subject's Average Mean Gradient Measurements Over Time. | 6 months | 9.7 mmHg | Standard Deviation 3.4 |
| Per Protocol Cohort - 23mm | Subject's Average Mean Gradient Measurements Over Time. | 6 months | 8.0 mmHg | Standard Deviation 3.7 |
| Per Protocol Cohort - 23mm | Subject's Average Mean Gradient Measurements Over Time. | Baseline | 44.5 mmHg | Standard Deviation 13 |
| Per Protocol Cohort - 23mm | Subject's Average Mean Gradient Measurements Over Time. | Discharge | 9.7 mmHg | Standard Deviation 3.4 |
| Per Protocol Cohort - 25mm | Subject's Average Mean Gradient Measurements Over Time. | 6 months | 7.8 mmHg | Standard Deviation 2.6 |
| Per Protocol Cohort - 25mm | Subject's Average Mean Gradient Measurements Over Time. | Baseline | 45.3 mmHg | Standard Deviation 13.4 |
| Per Protocol Cohort - 25mm | Subject's Average Mean Gradient Measurements Over Time. | Discharge | 9.8 mmHg | Standard Deviation 3.6 |
| Per Protocol Cohort - 27mm | Subject's Average Mean Gradient Measurements Over Time. | Discharge | 7.6 mmHg | Standard Deviation 3 |
| Per Protocol Cohort - 27mm | Subject's Average Mean Gradient Measurements Over Time. | Baseline | 45.1 mmHg | Standard Deviation 16.5 |
| Per Protocol Cohort - 27mm | Subject's Average Mean Gradient Measurements Over Time. | 6 months | 6.1 mmHg | Standard Deviation 2.9 |
| Per Protocol Cohort - Total | Subject's Average Mean Gradient Measurements Over Time. | Baseline | 46.0 mmHg | Standard Deviation 14.1 |
| Per Protocol Cohort - Total | Subject's Average Mean Gradient Measurements Over Time. | 6 months | 8.8 mmHg | Standard Deviation 3.7 |
| Per Protocol Cohort - Total | Subject's Average Mean Gradient Measurements Over Time. | Discharge | 11.1 mmHg | Standard Deviation 4.7 |
Secondary
Subject's Average Peak Gradients Measurements Over Time.
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
Time frame: Baseline, Discharge and 6 months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Average Peak Gradients Measurements Over Time. | Discharge | 28.0 mmHg | Standard Deviation 10.4 |
| Per Protocol Cohort | Subject's Average Peak Gradients Measurements Over Time. | Baseline | 80.3 mmHg | Standard Deviation 25.9 |
| Per Protocol Cohort | Subject's Average Peak Gradients Measurements Over Time. | 6 months | 23.6 mmHg | Standard Deviation 8.4 |
| Per Protocol Cohort - 21mm | Subject's Average Peak Gradients Measurements Over Time. | Discharge | 25.0 mmHg | Standard Deviation 10.7 |
| Per Protocol Cohort - 21mm | Subject's Average Peak Gradients Measurements Over Time. | Baseline | 78.9 mmHg | Standard Deviation 22.8 |
| Per Protocol Cohort - 21mm | Subject's Average Peak Gradients Measurements Over Time. | 6 months | 19.7 mmHg | Standard Deviation 7.6 |
| Per Protocol Cohort - 23mm | Subject's Average Peak Gradients Measurements Over Time. | Discharge | 18.4 mmHg | Standard Deviation 6.6 |
| Per Protocol Cohort - 23mm | Subject's Average Peak Gradients Measurements Over Time. | Baseline | 73.4 mmHg | Standard Deviation 20.8 |
| Per Protocol Cohort - 23mm | Subject's Average Peak Gradients Measurements Over Time. | 6 months | 15.7 mmHg | Standard Deviation 6.7 |
| Per Protocol Cohort - 25mm | Subject's Average Peak Gradients Measurements Over Time. | Discharge | 18.6 mmHg | Standard Deviation 7.3 |
| Per Protocol Cohort - 25mm | Subject's Average Peak Gradients Measurements Over Time. | Baseline | 74.8 mmHg | Standard Deviation 20.9 |
| Per Protocol Cohort - 25mm | Subject's Average Peak Gradients Measurements Over Time. | 6 months | 15.0 mmHg | Standard Deviation 4.7 |
| Per Protocol Cohort - 27mm | Subject's Average Peak Gradients Measurements Over Time. | Discharge | 15.3 mmHg | Standard Deviation 6.2 |
| Per Protocol Cohort - 27mm | Subject's Average Peak Gradients Measurements Over Time. | Baseline | 74.0 mmHg | Standard Deviation 22 |
| Per Protocol Cohort - 27mm | Subject's Average Peak Gradients Measurements Over Time. | 6 months | 12.6 mmHg | Standard Deviation 4.9 |
| Per Protocol Cohort - Total | Subject's Average Peak Gradients Measurements Over Time. | Baseline | 76.3 mmHg | Standard Deviation 22.1 |
| Per Protocol Cohort - Total | Subject's Average Peak Gradients Measurements Over Time. | 6 months | 17.5 mmHg | Standard Deviation 7.4 |
| Per Protocol Cohort - Total | Subject's Average Peak Gradients Measurements Over Time. | Discharge | 21.4 mmHg | Standard Deviation 9.5 |
Secondary
Subject's Average Performance Index Measurements 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 pre-implant orifice area. Effective orifice area is evaluated by echocardiography over time.
Time frame: Baseline, Discharge and 6 months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Average Performance Index Measurements Over Time. | Discharge | 0.9 cm2/cm2 | Standard Deviation 0.2 |
| Per Protocol Cohort | Subject's Average Performance Index Measurements Over Time. | Baseline | 0.5 cm2/cm2 | Standard Deviation 0.1 |
| Per Protocol Cohort | Subject's Average Performance Index Measurements Over Time. | 6 months | 1.0 cm2/cm2 | Standard Deviation 0.2 |
| Per Protocol Cohort - 21mm | Subject's Average Performance Index Measurements Over Time. | Discharge | 1.0 cm2/cm2 | Standard Deviation 0.4 |
| Per Protocol Cohort - 21mm | Subject's Average Performance Index Measurements Over Time. | Baseline | 0.5 cm2/cm2 | Standard Deviation 0.2 |
| Per Protocol Cohort - 21mm | Subject's Average Performance Index Measurements Over Time. | 6 months | 1.0 cm2/cm2 | Standard Deviation 0.2 |
| Per Protocol Cohort - 23mm | Subject's Average Performance Index Measurements Over Time. | Discharge | 1.0 cm2/cm2 | Standard Deviation 0.3 |
| Per Protocol Cohort - 23mm | Subject's Average Performance Index Measurements Over Time. | Baseline | 0.4 cm2/cm2 | Standard Deviation 0.1 |
| Per Protocol Cohort - 23mm | Subject's Average Performance Index Measurements Over Time. | 6 months | 1.0 cm2/cm2 | Standard Deviation 0.3 |
| Per Protocol Cohort - 25mm | Subject's Average Performance Index Measurements Over Time. | 6 months | 1.0 cm2/cm2 | Standard Deviation 0.2 |
| Per Protocol Cohort - 25mm | Subject's Average Performance Index Measurements Over Time. | Baseline | 0.4 cm2/cm2 | Standard Deviation 0.1 |
| Per Protocol Cohort - 25mm | Subject's Average Performance Index Measurements Over Time. | Discharge | 1.0 cm2/cm2 | Standard Deviation 0.3 |
| Per Protocol Cohort - 27mm | Subject's Average Performance Index Measurements Over Time. | Baseline | 0.4 cm2/cm2 | Standard Deviation 0.1 |
| Per Protocol Cohort - 27mm | Subject's Average Performance Index Measurements Over Time. | Discharge | 0.9 cm2/cm2 | Standard Deviation 0.3 |
| Per Protocol Cohort - 27mm | Subject's Average Performance Index Measurements Over Time. | 6 months | 1.0 cm2/cm2 | Standard Deviation 0.2 |
| Per Protocol Cohort - Total | Subject's Average Performance Index Measurements Over Time. | Discharge | 1.0 cm2/cm2 | Standard Deviation 0.3 |
| Per Protocol Cohort - Total | Subject's Average Performance Index Measurements Over Time. | Baseline | 0.5 cm2/cm2 | Standard Deviation 0.2 |
| Per Protocol Cohort - Total | Subject's Average Performance Index Measurements Over Time. | 6 months | 1.0 cm2/cm2 | Standard Deviation 0.2 |
Secondary
Subject's Average Time Spent on Cardiopulmonary Bypass.
Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.
Time frame: At time of surgery; an average of 1.5 hours
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Per Protocol Cohort | Subject's Average Time Spent on Cardiopulmonary Bypass. | 79.0 minutes | Standard Deviation 23.4 |
Other Pre-specified
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
Time frame: Events occurring within 30 days of procedure
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | All Cause Mortality | 1.1 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Trial Valve Related Mortality | 0.0 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Thromboembolism | 3.6 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Stroke | 2.9 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | TIA | 0.0 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Non-cerebral Embolism | 0.7 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Valve Thrombosis | 0.0 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Major Bleeding | 0.4 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Minor Paravalvular Leak (OPC) | 0.4 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Major Paravalvular Leak (OPC) | 0.4 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Hemolysis | 0.0 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | NSVD Other than PVL | 0.0 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Endocarditis | 0.0 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Structural Valve Deterioration | 0.0 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Reoperation | 0.0 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Explant | 0.0 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Renal Failure | 2.2 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Respiratory Failure/Dysfunction | 1.1 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Deep Sternal Wound Infection | 0.7 Percentage of events/subjects |
| Per Protocol Cohort | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Permanent Pacemaker Implant | 6.7 Percentage of events/subjects |
Other Pre-specified
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Number of late adverse events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Time frame: Events occuring >= 31 days and up through 6 months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | All Cause Mortality | 6.1 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Trial Valve Related Mortality | 3.5 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Thromboembolism | 1.7 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Stroke | 1.7 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | TIA | 0.0 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Non-cerebral Embolism | 0.0 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Valve Thrombosis | 0.0 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Major Bleeding | 2.6 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Minor Paravalvular Leak (OPC) | 0.0 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Major Paravalvular Leak (OPC) | 0.9 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Hemolysis | 0.0 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | NSVD Other than PVL | 0.9 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Endocarditis | 0.0 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Structural Valve Deterioration | 0.9 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Reoperation | 1.7 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Explant | 1.7 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Renal Failure | 0.0 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Respiratory Failure/Dysfunction | 0.9 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Deep Sternal Wound Infection | 1.7 percentage of events/late patient years |
| Per Protocol Cohort | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Permanent Pacemaker Implant | 1.8 percentage of events/late patient years |
Other Pre-specified
Subject's Average Fitness for Hospital Discharge
Considered as the day at which the patient was fit for hospital discharge.
Time frame: Day of surgical procedure through discharge from the hospital; an average of 7 days
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Per Protocol Cohort | Subject's Average Fitness for Hospital Discharge | 6.8 days | Standard Deviation 6.1 |
Other Pre-specified
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time
The EuroQol-5 Dimension (EQ-5D) is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Time frame: Baseline and 6 months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time | Baseline | 0.73 units on a scale | Standard Deviation 0.21 |
| Per Protocol Cohort | Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time | 6 months | 0.82 units on a scale | Standard Deviation 0.22 |
Other Pre-specified
Subject's Average SF-36 Mental Health Summary
The Medical Outcomes Study Short-Form 36 - Mental Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.
Time frame: Baseline and 6 months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Average SF-36 Mental Health Summary | 6 months | 50.1 units on a scale | Standard Deviation 10.1 |
| Per Protocol Cohort | Subject's Average SF-36 Mental Health Summary | Baseline | 45.5 units on a scale | Standard Deviation 10.4 |
Other Pre-specified
Subject's Average SF-36 Physical Health Summary
The Medical Outcomes Study Short-Form 36 - Physical Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.
Time frame: Baseline and 6 months
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's Average SF-36 Physical Health Summary | Baseline | 42.6 units on a scale | Standard Deviation 8.1 |
| Per Protocol Cohort | Subject's Average SF-36 Physical Health Summary | 6 months | 47.6 units on a scale | Standard Deviation 8.1 |
Other Pre-specified
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
Time frame: 6 months compared to baseline
Population: The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class I | Class I | 9 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class I | Class II | 0 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class I | Class III | 0 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class I | Class IV | 0 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class II | Class I | 85 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class II | Class II | 25 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class II | Class III | 1 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class II | Class IV | 0 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class III | Class I | 71 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class III | Class II | 38 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class III | Class III | 6 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class III | Class IV | 0 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class IV | Class I | 4 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class IV | Class II | 0 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class IV | Class III | 0 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | Preoperative Classification, Class IV | Class IV | 0 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | All Subjects | Class I | 169 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | All Subjects | Class II | 63 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | All Subjects | Class III | 7 Participants |
| Per Protocol Cohort | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | All Subjects | Class IV | 0 Participants |