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EDWARDS INTUITY Valve System FOUNDATION Study

Sponsor
Edwards Lifesciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02338154
Collaborator
(none)
516
Enrollment
27
Locations
45
Duration (Months)
19.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.

The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Aortic valve replacement with mechanical or biological heart valves is the treatment of choice for aortic valve stenosis. Over the past several years, life expectancy has increased in industrial nations, but this has been accompanied by a rising rate of elderly patients with multiple illnesses.

    Aortic stenosis remains the most common cause of adult valvular heart disease, the prevalence increasing with age. Average survival of patients treated conservatively has historically been reported as 2-5 years from the onset of symptoms. More recent studies have confirmed the dismal prognosis of severe aortic stenosis. Advanced age, reduced left ventricular ejection fraction, congestive heart failure and renal insufficiency appear to be independent predictors of reduced survival. Asymptomatic patients with very severe aortic stenosis also share a poor prognosis with a high event rate and a risk of rapid functional deterioration. Early surgery offers a therapeutic option to improve clinical outcomes via decreasing cardiac mortality and improving symptoms.

    Bioprostheses offer several advantages over mechanical bioprostheses, the most important being freedom from anticoagulation with a low rate of thromboembolic accidents.

    In response to clinical need and in support of advances in minimally invasive surgical approaches to conventional AVR, Edwards Lifesciences developed the EDWARDS INTUITY Valve System to achieve clinical benefits by reducing cardiopulmonary bypass and cross clamp times, while facilitating a less invasive approach to aortic valve replacement.

    The system includes the EDWARDS INTUITY Valve System, Model 8300A and the EDWARDS INTUITY Delivery System, Model 8300D; the valve is based on prior heart valve designs which have a long history of safety and effectiveness and have incorporated additional features designed to improve patient outcomes and safety.

    With only 3 guiding sutures and secure balloon expandable frame, the EDWARDS INTUITY Valve system is well suited for smaller incisions and tight access, with an emphasis on procedural efficiency within existing operating suite of the surgeon.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    516 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study.
    Study Start Date :
    Jul 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2016
    Actual Study Completion Date :
    Apr 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Subject's Average Time Spent on Cardiopulmonary Cross Clamp [At time of surgery; an average of 1 hour]

      Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.

    Other Outcome Measures

    1. 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.

    2. Subject's Average Skin-to-skin Time [At time of surgery; an average of 3.5 hours]

      The time from start of skin incision to end of skin closure.

    3. Subject's Device Technical Success [At time of surgery]

      Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with the subject leaving the operating room (OR) with valve in place.

    4. Subject's Average Health Care Utilization [Day of surgical procedure through discharge from the ICU and hospital, an average of 3 days and 11 days respectively.]

      The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure.

    5. Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline [30 days, 3 months, 1 year, 2 years]

      The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.

    6. Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time [Baseline, 3 months]

      The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.

    7. Subject's Average Mean Gradient Measurements [Baseline, discharge, 3 months, and 1 year]

      Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

    8. Subject's Average Peak Gradients (mmHg) Measurements Over Time [Baseline, discharge, 3 months, and 1 year]

      Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.

    9. Subject's Average Effective Orifice Area Measurements [Baseline, discharge, 3 months, 1 year]

      Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.

    10. Subject's Average Effective Orifice Area Index (EOAI) Measurements [Baseline, Discharge, 3 months, 1 year]

      Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.

    11. Subject's Average Performance Index Measurements [Discharge, 3 Months, 1 Year]

      Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.

    12. Subject's Average Left Ventricular Ejection Fraction (LVEF) [Baseline, discharge, 3 months, 1 year]

      Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. Ejection fraction is evaluated by echocardiography over time. A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%.

    13. Subject's Amount of Aortic Valvular Regurgitation Over Time. [Discharge, 3 months, 1 year]

      Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

    14. Subject's Amount of Paravalvular Leak Over Time. [Discharge, 3 months, 1 year]

      Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.

    15. Subject's Average Cardiac Output Over Time [Discharge, 3 months, 1 year]

      The amount of blood the heart pumps through the circulatory system in a minute.

    16. Subject's Average Cardiac Output Index [Discharge, 3 Months, 1 Year]

      A hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA).

    17. Subject's Average Left Ventricular End-Diastolic Dimension [Baseline, Discharge, 3 Months, 1 Year]

      The measurement of the heart's left ventricle at end diastole.

    18. Subject's Average Left Ventricular End-Systolic Dimension [Baseline, Discharge, 3 Months, 1 Year]

      The measurement of the heart's left ventricle at end systole.

    19. Left Ventricular End-diastolic Volume (LVEDV) [Baseline, Discharge, 3 Months, 1 Year]

      Left Ventricular end-diastolic volume (LVEDV) is the amount of (volume) of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole.

    20. Left Ventricular End-systolic Volume (LVESV) [Baseline, Discharge, 3 Months, 1 Year]

      Left Ventricular end-systolic volume (LVESV) is the amount of (volume) of blood in the left ventricle at the end of the heart's contraction, or systole, and the beginning of filling, or diastole.

    21. Percentage of Subjects With Early Adverse Events [Events occurring within 30 days of procedure]

      Number of Subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.

    22. Percentage of Late Adverse Events Divided by Late Patient Years [Events occurring >= 31 days and up through 2 years post-implant]

      Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subject is 18 years or older

    2. Subject presents with aortic stenosis or stenosis-based insufficiency of an aortic valve requiring a planned replacement of the native aortic valve or previously implanted aortic prosthesis.

    3. Subject has signed and dated the investigation informed consent forms prior to study-specific procedures are performed.

    4. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.

    Exclusion Criteria:

    1. History of active endocarditis within three months of scheduled surgery

    2. Subject is diagnosed with pure aortic insufficiency

    3. Aneurysm of the aortic root and/or ascending aorta

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Salzburger Universitätsklinikum Salzburg Austria 5020
    2 Landesklinikum - St. Pölten St Pölten Austria 3100
    3 Klinisshe Abteiluing Für Herz-thoraxchirurgie Vienna Austria 1090
    4 Aarhus Universitetshospital Skejby Aarhus N Denmark 8200
    5 CHU Bocage Central Dijon Dijon France 21074
    6 Hôpital Saint Joseph - Marseille Marseille Cedex France 13285
    7 Centre Hospitalier de Mulhouse Mulhouse Cedex France 68051
    8 Centre Cardiologique du Nord St Denis St Denis France 93200
    9 Herz- und Gefäß-Klinik GmbH Bad Neustadt Bad Neustadt An Der Saale Germany 97616
    10 Westdeutsches Herzcentrum Uniklinik Essen Essen Germany 45147
    11 Klinikum Nürnberg Süd Nürenberg Germany 90471
    12 Clinica Santa Maria Bari Italy 70124
    13 S. Anna Hospital Catanzaro Italy 88100
    14 G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation Massa Italy 54100
    15 Centro Cardiologico Monzino Milan Italy 20138
    16 Ospedale Niguarda Ca' Granda Milan Italy 20162
    17 Università Cattolica del Sacro Cuore Policlinico Roma Italy 00168
    18 Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" Udine Italy 33100
    19 Catharina Hospital Eindhoven Eindhoven Netherlands 5623
    20 Hospital Universitario Virgen de la Arrixaca El Palmar Murcia Spain 30120
    21 Hospital Universitario Cruces Barakaldo Barakaldo Spain 48903
    22 Hospital Clínico San Carlos Madrid Spain 28040
    23 Universitätsklinik Für Herz und Gefässchirurgie Bern Switzerland 3010
    24 Cardiocentro Ticino Lugano Switzerland 6903
    25 Universität Zurich Zurich Switzerland 8091
    26 St Thomas' Hospital London United Kingdom SE1 7EH
    27 King's College Hospital London United Kingdom SE5 9RS

    Sponsors and Collaborators

    • Edwards Lifesciences

    Investigators

    • Principal Investigator: Dr. Glauber, MD, Organizational Affiliation: OSPEDALE "G. PASQUINUCCI" CREAS IFC-CNR
    • Principal Investigator: Prof.Christopher Young, MD FRCS, Guy's & St Thomas' Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Edwards Lifesciences
    ClinicalTrials.gov Identifier:
    NCT02338154
    Other Study ID Numbers:
    • 2011-13
    First Posted:
    Jan 14, 2015
    Last Update Posted:
    Nov 22, 2019
    Last Verified:
    Nov 1, 2019
    Keywords provided by Edwards Lifesciences
    Aortic Valve Replacement
    Aortic Stenosis
    EDWARDS INTUITY
    Additional relevant MeSH terms:
    Aortic Valve Stenosis
    Aortic Valve Disease

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 516 Subjects were enrolled in this study, for which data is available.
    Arm/Group Title EDWARDS INTUITY Aortic Valve
    Arm/Group Description Aortic valve replacement therapy Heart Valve Surgery: The system includes the EDWARDS INTUITY Valve System, Model 8300A and the EDWARDS INTUITY Delivery System, Model 8300D
    Period Title: Overall Study
    STARTED 516
    Enrolled Cohort (Intent to Treat) 516
    INTUITY (Study Valve Cohort) 493
    COMPLETED 373
    NOT COMPLETED 143

    Baseline Characteristics

    Arm/Group Title Enrolled Cohort
    Arm/Group Description Subjects were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon placed the first guiding suture on the bioprosthesis.
    Overall Participants 516
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    75.5
    (6.4)
    Sex/Gender, Customized (Count of Participants)
    Female
    223
    43.2%
    Male
    293
    56.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    218
    42.2%
    Not Hispanic or Latino
    240
    46.5%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    1
    0.2%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    456
    88.4%
    More than one race
    0
    0%
    Unknown or Not Reported
    1
    0.2%

    Outcome Measures

    1. Primary Outcome
    Title Subject's Average Time Spent on Cardiopulmonary Cross Clamp
    Description 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

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort)
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 476
    Mean (Standard Deviation) [minutes]
    59.7
    (24.0)
    2. Other Pre-specified Outcome
    Title Subject's Average Time Spent on Cardiopulmonary Bypass
    Description 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

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort)
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 474
    Mean (Standard Deviation) [minutes]
    85.9
    (33.0)
    3. Other Pre-specified Outcome
    Title Subject's Average Skin-to-skin Time
    Description The time from start of skin incision to end of skin closure.
    Time Frame At time of surgery; an average of 3.5 hours

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort)
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 478
    Mean (Standard Deviation) [Minutes]
    199.3
    (69.8)
    4. Other Pre-specified Outcome
    Title Subject's Device Technical Success
    Description Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with the subject leaving the operating room (OR) with valve in place.
    Time Frame At time of surgery

    Outcome Measure Data

    Analysis Population Description
    The outcome is reported for subjects where data is available.
    Arm/Group Title Enrolled Cohort
    Arm/Group Description Subject were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon placed the first guiding suture on the bioprosthesis.
    Measure Participants 516
    Count of Participants [Participants]
    493
    95.5%
    5. Other Pre-specified Outcome
    Title Subject's Average Health Care Utilization
    Description The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure.
    Time Frame Day of surgical procedure through discharge from the ICU and hospital, an average of 3 days and 11 days respectively.

    Outcome Measure Data

    Analysis Population Description
    The outcome is reported for subjects where data is available.
    Arm/Group Title Enrolled Cohort
    Arm/Group Description Subject were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon placed the first guiding suture on the bioprosthesis.
    Measure Participants 516
    ICU Length of Stay
    2.8
    (3.9)
    Hospital Length of Stay
    11.2
    (18.4)
    6. Other Pre-specified Outcome
    Title Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
    Description The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
    Time Frame 30 days, 3 months, 1 year, 2 years

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort)
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 493
    Improved
    272
    52.7%
    Same
    129
    25%
    Worsened
    17
    3.3%
    Improved
    326
    63.2%
    Same
    99
    19.2%
    Worsened
    8
    1.6%
    Improved
    293
    56.8%
    Same
    63
    12.2%
    Worsened
    8
    1.6%
    Improved
    255
    49.4%
    Same
    80
    15.5%
    Worsened
    15
    2.9%
    7. Other Pre-specified Outcome
    Title Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
    Description The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
    Time Frame Baseline, 3 months

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort)
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 493
    Baseline
    0.818
    (0.137)
    3 Months
    0.864
    (0.149)
    Change from Baseline to 3 Months
    0.040
    (0.131)
    8. Other Pre-specified Outcome
    Title Subject's Average Mean Gradient Measurements
    Description Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
    Time Frame Baseline, discharge, 3 months, and 1 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    Baseline
    51.22
    (21.24)
    49.11
    (16.81)
    47.51
    (16.70)
    44.36
    (13.33)
    44.83
    (14.79)
    47.74
    (16.90)
    Discharge
    15.83
    (8.35)
    11.74
    (6.42)
    10.69
    (5.98)
    10.69
    (7.65)
    7.77
    (2.96)
    11.61
    (7.00)
    3 months
    14.58
    (8.26)
    10.96
    (6.01)
    9.73
    (5.98)
    8.34
    (4.68)
    7.38
    (2.80)
    10.36
    (6.34)
    1 Year
    13.16
    (6.90)
    10.14
    (4.28)
    8.96
    (3.72)
    8.45
    (3.03)
    7.25
    (3.13)
    9.64
    (4.60)
    9. Other Pre-specified Outcome
    Title Subject's Average Peak Gradients (mmHg) Measurements Over Time
    Description Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
    Time Frame Baseline, discharge, 3 months, and 1 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    Baseline
    83.75
    (33.17)
    78.92
    (28.21)
    77.08
    (25.15)
    73.11
    (20.92)
    72.51
    (21.22)
    77.56
    (26.55)
    Discharge
    29.42
    (12.83)
    21.88
    (10.53)
    20.29
    (9.75)
    19.78
    (12.28)
    14.00
    (5.63)
    21.65
    (11.40)
    3 Months
    27.46
    (13.64)
    21.12
    (10.32)
    19.48
    (11.90)
    16.52
    (7.82)
    14.00
    (4.96)
    20.18
    (11.32)
    1 Year
    23.88
    (8.57)
    18.29
    (7.17)
    16.97
    (6.77)
    15.40
    (4.94)
    13.29
    (5.37)
    17.70
    (7.31)
    10. Other Pre-specified Outcome
    Title Subject's Average Effective Orifice Area Measurements
    Description Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
    Time Frame Baseline, discharge, 3 months, 1 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    Baseline
    0.62
    (0.16)
    0.71
    (0.29)
    0.75
    (0.34)
    0.74
    (0.26)
    0.81
    (0.25)
    0.72
    (0.29)
    Discharge
    1.17
    (0.41)
    1.66
    (0.53)
    2.00
    (0.64)
    2.18
    (0.70)
    2.83
    (0.90)
    1.86
    (0.73)
    3 Months
    1.14
    (0.39)
    1.59
    (0.52)
    1.86
    (0.62)
    2.10
    (0.59)
    2.54
    (0.77)
    1.77
    (0.67)
    1 Year
    1.28
    (0.33)
    1.61
    (0.43)
    1.97
    (0.42)
    2.23
    (0.65)
    2.64
    (0.73)
    1.88
    (0.63)
    11. Other Pre-specified Outcome
    Title Subject's Average Effective Orifice Area Index (EOAI) Measurements
    Description Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
    Time Frame Baseline, Discharge, 3 months, 1 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
    Arm/Group Title INUTITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    Baseline
    0.37
    (0.10)
    0.41
    (0.18)
    0.40
    (0.17)
    0.37
    (0.14)
    0.40
    (0.12)
    0.39
    (0.16)
    Discharge
    0.69
    (0.26)
    0.92
    (0.31)
    1.05
    (0.34)
    1.15
    (0.35)
    1.40
    (0.50)
    0.99
    (0.38)
    3 Months
    0.69
    (0.24)
    0.91
    (0.31)
    0.99
    (0.40)
    1.09
    (0.34)
    1.23
    (0.42)
    0.96
    (0.37)
    1 Year
    0.76
    (0.21)
    0.92
    (0.26)
    1.06
    (0.22)
    1.13
    (0.33)
    1.30
    (0.48)
    1.01
    (0.31)
    12. Other Pre-specified Outcome
    Title Subject's Average Performance Index Measurements
    Description Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.
    Time Frame Discharge, 3 Months, 1 Year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
    Arm/Group Title INUTITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    Discharge
    0.44
    (0.12)
    0.49
    (0.13)
    0.53
    (0.14)
    0.49
    (0.12)
    0.56
    (0.12)
    0.50
    (0.13)
    3 Months
    0.44
    (0.12)
    0.50
    (0.12)
    0.55
    (0.13)
    0.52
    (0.13)
    0.57
    (0.13)
    0.52
    (0.13)
    1 Year
    0.48
    (0.12)
    0.51
    (0.14)
    0.55
    (0.12)
    0.53
    (0.13)
    0.58
    (0.13)
    0.53
    (0.13)
    13. Other Pre-specified Outcome
    Title Subject's Average Left Ventricular Ejection Fraction (LVEF)
    Description Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. Ejection fraction is evaluated by echocardiography over time. A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%.
    Time Frame Baseline, discharge, 3 months, 1 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    Baseline
    66.71
    (9.85)
    65.87
    (11.89)
    64.56
    (11.73)
    60.57
    (12.85)
    62.96
    (9.29)
    64.37
    (11.75)
    Discharge
    66.05
    (11.40)
    64.16
    (11.63)
    65.87
    (10.70)
    60.45
    (12.57)
    61.12
    (13.36)
    64.16
    (11.73)
    3 Months
    64.58
    (6.96)
    66.26
    (9.88)
    65.20
    (9.51)
    62.36
    (11.29)
    63.08
    (10.24)
    64.67
    (9.79)
    1 Year
    64.28
    (8.12)
    64.64
    (8.23)
    64.65
    (8.98)
    63.30
    (7.75)
    63.64
    (9.35)
    64.23
    (8.41)
    14. Other Pre-specified Outcome
    Title Subject's Amount of Aortic Valvular Regurgitation Over Time.
    Description Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
    Time Frame Discharge, 3 months, 1 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    0 None
    34
    6.6%
    69
    NaN
    83
    NaN
    52
    NaN
    19
    NaN
    260
    NaN
    +1 Trivial/Trace
    29
    5.6%
    39
    NaN
    42
    NaN
    22
    NaN
    6
    NaN
    140
    NaN
    +2 Mild
    5
    1%
    9
    NaN
    9
    NaN
    4
    NaN
    1
    NaN
    28
    NaN
    +3 Moderate
    0
    0%
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    1
    NaN
    +4 Severe
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0 None
    25
    4.8%
    67
    NaN
    80
    NaN
    55
    NaN
    21
    NaN
    249
    NaN
    +1 Trivial/Trace
    28
    5.4%
    39
    NaN
    43
    NaN
    24
    NaN
    8
    NaN
    144
    NaN
    +2 Mild
    7
    1.4%
    7
    NaN
    9
    NaN
    4
    NaN
    1
    NaN
    28
    NaN
    +3 Moderate
    1
    0.2%
    2
    NaN
    5
    NaN
    0
    NaN
    0
    NaN
    8
    NaN
    +4 Severe
    0
    0%
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    1
    NaN
    0 None
    29
    5.6%
    60
    NaN
    78
    NaN
    49
    NaN
    18
    NaN
    236
    NaN
    +1 Trivial/Trace
    15
    2.9%
    23
    NaN
    21
    NaN
    17
    NaN
    9
    NaN
    85
    NaN
    +2 Mild
    5
    1%
    9
    NaN
    12
    NaN
    3
    NaN
    1
    NaN
    30
    NaN
    +3 Moderate
    1
    0.2%
    1
    NaN
    3
    NaN
    0
    NaN
    0
    NaN
    5
    NaN
    +4 Severe
    0
    0%
    0
    NaN
    2
    NaN
    0
    NaN
    0
    NaN
    2
    NaN
    15. Other Pre-specified Outcome
    Title Subject's Amount of Paravalvular Leak Over Time.
    Description Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
    Time Frame Discharge, 3 months, 1 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    0 None
    59
    11.4%
    99
    NaN
    105
    NaN
    69
    NaN
    22
    NaN
    358
    NaN
    +1 Trivial/Trace
    4
    0.8%
    18
    NaN
    25
    NaN
    6
    NaN
    1
    NaN
    55
    NaN
    +2 Mild
    4
    0.8%
    1
    NaN
    6
    NaN
    4
    NaN
    1
    NaN
    16
    NaN
    +3 Moderate
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    +4 Severe
    0
    0%
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    1
    NaN
    0 None
    52
    10.1%
    84
    NaN
    96
    NaN
    67
    NaN
    22
    NaN
    324
    NaN
    +1 Trivial/Trace
    5
    1%
    20
    NaN
    22
    NaN
    11
    NaN
    5
    NaN
    63
    NaN
    +2 Mild
    3
    0.6%
    6
    NaN
    12
    NaN
    4
    NaN
    1
    NaN
    26
    NaN
    +3 Moderate
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    +4 Severe
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0 None
    32
    6.2%
    64
    NaN
    65
    NaN
    56
    NaN
    20
    NaN
    238
    NaN
    +1 Trivial/Trace
    9
    1.7%
    17
    NaN
    16
    NaN
    6
    NaN
    4
    NaN
    53
    NaN
    +2 Mild
    1
    0.2%
    2
    NaN
    14
    NaN
    3
    NaN
    0
    NaN
    20
    NaN
    +3 Moderate
    1
    0.2%
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    2
    NaN
    +4 Severe
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    16. Other Pre-specified Outcome
    Title Subject's Average Cardiac Output Over Time
    Description The amount of blood the heart pumps through the circulatory system in a minute.
    Time Frame Discharge, 3 months, 1 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    Discharge
    4.14
    (1.39)
    4.24
    (1.31)
    4.60
    (1.33)
    4.74
    (1.48)
    5.09
    (1.82)
    4.49
    (1.42)
    3 Months
    3.85
    (1.40)
    4.36
    (1.15)
    4.29
    (1.12)
    4.16
    (1.19)
    5.08
    (1.57)
    4.26
    (1.23)
    1 Year
    3.86
    (1.28)
    4.26
    (1.11)
    4.61
    (1.30)
    4.61
    (1.30)
    5.90
    (1.76)
    4.50
    (1.37)
    17. Other Pre-specified Outcome
    Title Subject's Average Cardiac Output Index
    Description A hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA).
    Time Frame Discharge, 3 Months, 1 Year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    Discharge
    2.45
    (0.89)
    2.40
    (0.79)
    2.44
    (0.75)
    2.54
    (0.72)
    2.45
    (0.77)
    2.45
    (0.78)
    3 Months
    2.40
    (0.88)
    2.54
    (0.67)
    2.33
    (0.62)
    2.21
    (0.65)
    2.61
    (1.00)
    2.40
    (0.72)
    1 Year
    2.32
    (0.81)
    2.47
    (0.68)
    2.49
    (0.71)
    2.32
    (0.65)
    2.88
    (1.09)
    2.45
    (0.74)
    18. Other Pre-specified Outcome
    Title Subject's Average Left Ventricular End-Diastolic Dimension
    Description The measurement of the heart's left ventricle at end diastole.
    Time Frame Baseline, Discharge, 3 Months, 1 Year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    Baseline
    4.05
    (0.58)
    4.30
    (0.74)
    4.38
    (0.63)
    4.76
    (0.72)
    4.92
    (0.67)
    4.41
    (0.72)
    Discharge
    3.92
    (0.67)
    4.09
    (0.68)
    4.35
    (0.65)
    4.51
    (0.73)
    4.67
    (1.30)
    4.27
    (0.76)
    3 Months
    3.93
    (0.59)
    4.17
    (0.59)
    4.25
    (0.62)
    4.55
    (0.68)
    4.88
    (0.79)
    4.29
    (0.67)
    1 Year
    3.98
    (0.64)
    4.08
    (0.71)
    4.43
    (0.54)
    4.47
    (0.72)
    4.72
    (0.64)
    4.30
    (0.68)
    19. Other Pre-specified Outcome
    Title Subject's Average Left Ventricular End-Systolic Dimension
    Description The measurement of the heart's left ventricle at end systole.
    Time Frame Baseline, Discharge, 3 Months, 1 Year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    Baseline
    2.63
    (0.60)
    2.80
    (0.75)
    2.99
    (0.72)
    3.29
    (0.91)
    3.36
    (0.82)
    2.96
    (0.79)
    Discharge
    2.60
    (0.65)
    2.80
    (0.73)
    2.97
    (0.69)
    3.07
    (0.70)
    3.32
    (0.84)
    2.92
    (0.72)
    3 Months
    2.53
    (0.56)
    2.70
    (0.62)
    2.81
    (0.56)
    3.02
    (0.67)
    3.31
    (0.75)
    2.82
    (0.64)
    1 Year
    2.63
    (0.61)
    2.69
    (0.69)
    2.90
    (0.54)
    2.91
    (0.68)
    3.06
    (0.68)
    2.82
    (0.64)
    20. Other Pre-specified Outcome
    Title Left Ventricular End-diastolic Volume (LVEDV)
    Description Left Ventricular end-diastolic volume (LVEDV) is the amount of (volume) of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole.
    Time Frame Baseline, Discharge, 3 Months, 1 Year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
    Arm/Group Title INUTITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    Baseline
    62.68
    (23.55)
    75.17
    (27.76)
    83.52
    (31.17)
    101.91
    (33.55)
    109.90
    (41.78)
    83.00
    (33.22)
    Discharge
    52.90
    (20.35)
    63.26
    (24.58)
    70.93
    (24.61)
    82.10
    (30.54)
    102.27
    (39.83)
    69.74
    (28.83)
    3 Months
    56.96
    (24.76)
    64.89
    (20.44)
    74.94
    (23.96)
    91.66
    (32.80)
    93.42
    (31.21)
    74.78
    (28.67)
    1 Year
    60.86
    (21.22)
    72.46
    (22.17)
    79.12
    (26.37)
    85.80
    (27.47)
    86.47
    (31.99)
    76.69
    (26.49)
    21. Other Pre-specified Outcome
    Title Left Ventricular End-systolic Volume (LVESV)
    Description Left Ventricular end-systolic volume (LVESV) is the amount of (volume) of blood in the left ventricle at the end of the heart's contraction, or systole, and the beginning of filling, or diastole.
    Time Frame Baseline, Discharge, 3 Months, 1 Year

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.
    Arm/Group Title INUTITY (Study Valve Cohort) - 19mm INTUITY (Study Valve Cohort) - 21mm INTUITY (Study Valve Cohort) - 23mm INTUITY (Study Valve Cohort) - 25mm INTUITY (Study Valve Cohort) - 27mm INTUITY (Study Valve Cohort) - Overall
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place. The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 73 134 157 92 30 486
    Baseline
    22
    (13.47)
    27.50
    (18.97)
    30.46
    (19.03)
    42.36
    (26.74)
    40.76
    (24.75)
    31.22
    (21.41)
    Discharge
    18.57
    (12.38)
    23.90
    (15.69)
    24.51
    (13.95)
    33.27
    (19.96)
    41.36
    (27.97)
    25.99
    (17.46)
    3 Months
    20.10
    (10.93)
    22.33
    (13.05)
    26.17
    (14.66)
    35.77
    (22.99)
    35.50
    (19.66)
    27.07
    (17.36)
    1 Year
    21.86
    (9.28)
    26.62
    (12.57)
    28.37
    (14.15)
    32.00
    (13.02)
    31.68
    (19.08)
    27.98
    (13.64)
    22. Other Pre-specified Outcome
    Title Percentage of Subjects With Early Adverse Events
    Description Number of Subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
    Time Frame Events occurring within 30 days of procedure

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort)
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 493
    All cause mortality
    3.0
    Study valve-related mortality
    1.4
    Thromboembolic events
    3.9
    Study valve thrombosis
    0.2
    Bleeding event
    6.3
    All paravalvular leak
    15.0
    Major paravalvular leak (Moderate or Severe)
    1.2
    Endocarditis
    0.0
    Structural valve deterioration
    0.0
    Non-structural valve deterioration (other than PVL
    0.0
    Hemolysis
    0.4
    Reoperation
    1.2
    Explant
    0.8
    New and worsening conduction disturbance
    7.3
    23. Other Pre-specified Outcome
    Title Percentage of Late Adverse Events Divided by Late Patient Years
    Description Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
    Time Frame Events occurring >= 31 days and up through 2 years post-implant

    Outcome Measure Data

    Analysis Population Description
    This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.
    Arm/Group Title INTUITY (Study Valve Cohort)
    Arm/Group Description The study valve cohort consists of all patients that left the operating room with the study valve in place.
    Measure Participants 493
    All cause mortality
    3.6
    Study valve-related mortality
    1.4
    Thromboembolic events
    1.6
    Study valve thrombosis
    0.0
    Bleeding event
    0.6
    All Paravalvular Leak
    10.8
    Major paravalvular leak (Moderate or Severe)
    1.3
    Endocarditis
    0.6
    Structural valve deterioration
    0.0
    Non-structural valve deterioration (other than PVL
    0.0
    Hemolysis
    0.4
    Reoperation
    1.1
    Explant
    0.7
    New and worsening conduction disturbance
    0.0

    Adverse Events

    Time Frame Events occurring from baseline through two (2) years post implant
    Adverse Event Reporting Description Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
    Arm/Group Title Enrolled Cohort
    Arm/Group Description Subject's were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon places the first guiding suture on the bioprosthesis.
    All Cause Mortality
    Enrolled Cohort
    Affected / at Risk (%) # Events
    Total 46/516 (8.9%)
    Serious Adverse Events
    Enrolled Cohort
    Affected / at Risk (%) # Events
    Total 245/516 (47.5%)
    Blood and lymphatic system disorders
    Anemia - Bleeding related - Major 2/516 (0.4%) 2
    Anemia - Bleeding related - Minor 3/516 (0.6%) 3
    Anemia - Non-bleeding related 10/516 (1.9%) 13
    Bleeding - Cardiovascular - Major 16/516 (3.1%) 18
    Bleeding - Cardiovascular - Minor 2/516 (0.4%) 2
    Bleeding - Gastrointestinal upper -Major 2/516 (0.4%) 2
    Bleeding - Gastrointestinal upper -Minor 1/516 (0.2%) 1
    Bleeding - Neurological - Major (e.g. CVA) 2/516 (0.4%) 2
    Bleeding - Pulmonary/Respiratory - Major (e.g. hemothorax) 1/516 (0.2%) 1
    Blood Sepsis 2/516 (0.4%) 2
    Blood/ Lymphatic - Other 2/516 (0.4%) 2
    Cardiac disorders
    Angina, Stable 1/516 (0.2%) 1
    Angina, Unstable 1/516 (0.2%) 1
    Arrhythmia - AV Block - 1st degree 1/516 (0.2%) 1
    Arrhythmia - AV Block - 2nd degree 3/516 (0.6%) 3
    Arrhythmia - AV Block - 3rd degree 25/516 (4.8%) 25
    Arrhythmia - Atrial Flutter 1/516 (0.2%) 1
    Arrhythmia - Bradycardia 4/516 (0.8%) 4
    Arrhythmia - Bundle Branch Block - Left 3/516 (0.6%) 3
    Arrhythmia - Other 5/516 (1%) 5
    Arrhythmia - Paroxysmal Atrial Fibrillation (PAF) 34/516 (6.6%) 39
    Arrhythmia - Permanent Atrial Fibrillation 3/516 (0.6%) 3
    Arrhythmia - Persistant Atrial Fibrillaiton 9/516 (1.7%) 12
    Arrhythmia - Tachycardia - Ventricular 3/516 (0.6%) 3
    Arrhythmia - Ventricular Fibrillation 2/516 (0.4%) 2
    Cardiac Arrest 4/516 (0.8%) 4
    Cardiac Decompensation 8/516 (1.6%) 8
    Cardiogenic Shock 2/516 (0.4%) 2
    Cardiovascular - Other 14/516 (2.7%) 14
    Endocarditis 5/516 (1%) 5
    Heart Failure - Acute 9/516 (1.7%) 11
    Heart Failure - Chronic (CHF) 2/516 (0.4%) 2
    Hypertension - Systemic 4/516 (0.8%) 4
    Hypotension 1/516 (0.2%) 1
    Myocardial Infarction 1/516 (0.2%) 1
    Perforation - Atrial 1/516 (0.2%) 1
    Perforation - Other 2/516 (0.4%) 2
    Pericardial Effusion - Major 2/516 (0.4%) 2
    Pericardial Effusion - Minor 1/516 (0.2%) 1
    Pericardial Tamponade - Major 2/516 (0.4%) 2
    Pleural Effusion - Bilateral 2/516 (0.4%) 2
    Pleural Effusion - Left 4/516 (0.8%) 4
    Pleural Effusion - Right 7/516 (1.4%) 7
    Regurgitation - Aortic-Central/Transvalvular-+3 1/516 (0.2%) 1
    Regurgitation - Aortic-Central/Transvalvular-+4 1/516 (0.2%) 1
    Regurgitation - Aortic-Indeterminate-+2 1/516 (0.2%) 1
    Regurgitation - Aortic-Indeterminate-+4 1/516 (0.2%) 1
    Thromboembolic Event - Other - Central - Hemiparesis 1/516 (0.2%) 1
    Thromboembolic Event - Other - Peripheral - No paresis 2/516 (0.4%) 2
    Thromboembolic Event - Stroke 10/516 (1.9%) 11
    Thromboembolic Event - Transient Ischemic Attack (TIA) 4/516 (0.8%) 4
    Valve Thrombosis - Aortic 1/516 (0.2%) 1
    Gastrointestinal disorders
    Biliary (Gallbladder) 5/516 (1%) 6
    Gastrointestinal - Infection 1/516 (0.2%) 1
    Gastrointestinal - Other 2/516 (0.4%) 2
    Pancreatic complication 1/516 (0.2%) 1
    General disorders
    Anaphylactic Reaction 1/516 (0.2%) 1
    Cancer - Newly diagnosed 9/516 (1.7%) 9
    Cancer - Progression of underlying disease 3/516 (0.6%) 3
    Multi-System organ failure 3/516 (0.6%) 3
    NSD - Paravalvular Leak - +2 3/516 (0.6%) 3
    NSD - Paravalvular Leak - +3 3/516 (0.6%) 4
    NSD - Paravalvular Leak - +4 2/516 (0.4%) 2
    Nonspecific, Unknown, or Other Body System - Other complication 17/516 (3.3%) 18
    Speech disorder 1/516 (0.2%) 1
    NSD - Paravalvular leak with Hemolysis 2/516 (0.4%) 2
    Hepatobiliary disorders
    Hepatic complication - Other 1/516 (0.2%) 1
    Liver Failure - Acute 1/516 (0.2%) 1
    Infections and infestations
    Infection /Inflammation - Other 5/516 (1%) 6
    Musculoskeletal and connective tissue disorders
    Bone Fracture/Break 8/516 (1.6%) 8
    Muscular Skeletal / Dermatologic - Other 17/516 (3.3%) 18
    Sternal Wound/Thoracic Infection 8/516 (1.6%) 10
    Product Issues
    SVD - Stent frame separation 1/516 (0.2%) 1
    Psychiatric disorders
    Psychiatric - Other 1/516 (0.2%) 1
    Psychiatric Disorder 1/516 (0.2%) 1
    Suicide 1/516 (0.2%) 1
    Renal and urinary disorders
    Genitourinary - Other 7/516 (1.4%) 7
    Renal Dysfunction 9/516 (1.7%) 9
    Renal Failure - Acute 12/516 (2.3%) 12
    Renal Failure - Chronic 2/516 (0.4%) 2
    Urinary Tract Infection (UTI) 3/516 (0.6%) 5
    Respiratory, thoracic and mediastinal disorders
    Atelectasis 2/516 (0.4%) 2
    Pneumothorax 1/516 (0.2%) 1
    Pulmonary Edema 1/516 (0.2%) 1
    Pulmonary Embolism - Bilateral 1/516 (0.2%) 1
    Pulmonary Embolism - Right 2/516 (0.4%) 2
    Pulmonary/Respiratory - Other 2/516 (0.4%) 2
    Respiratory Dysfunction/Insufficiency 2/516 (0.4%) 2
    Respiratory Failure -COPD 1/516 (0.2%) 1
    Respiratory Failure -Other 3/516 (0.6%) 3
    Respiratory Failure -Pneumonia 6/516 (1.2%) 6
    Respiratory Failure -Pneumothorax 1/516 (0.2%) 1
    Respiratory Infection - Pneumonia 10/516 (1.9%) 10
    Respiratory Infection - Upper (URI) 2/516 (0.4%) 2
    Respiratory Failure -Acute Respiratory Distress Syndrome (ARDS) 3/516 (0.6%) 3
    Vascular disorders
    Vascular - Other 8/516 (1.6%) 9
    Other (Not Including Serious) Adverse Events
    Enrolled Cohort
    Affected / at Risk (%) # Events
    Total 157/516 (30.4%)
    Blood and lymphatic system disorders
    Anemia - Bleeding related - Major 1/516 (0.2%) 1
    Anemia - Bleeding related - Minor 3/516 (0.6%) 3
    Anemia - Non-bleeding related 12/516 (2.3%) 13
    Bleeding - Cardiovascular - Minor 5/516 (1%) 5
    Bleeding - Gastrointestinal lower -Minor 1/516 (0.2%) 1
    Bleeding - Gastrointestinal upper -Minor 3/516 (0.6%) 3
    Bleeding - Genitourinary - Minor 1/516 (0.2%) 1
    Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas) 1/516 (0.2%) 1
    Blood/ Lymphatic - Other 3/516 (0.6%) 3
    Thrombocytopenia - Non-Heparin Induced 5/516 (1%) 5
    Cardiac disorders
    Angina, Stable 1/516 (0.2%) 1
    Arrhythmia - AV Block - 1st degree 2/516 (0.4%) 2
    Arrhythmia - AV Block - 3rd degree 1/516 (0.2%) 1
    Arrhythmia - Bundle Branch Block - Left 12/516 (2.3%) 12
    Arrhythmia - Bundle Branch Block - Right 1/516 (0.2%) 1
    Arrhythmia - Paroxysmal Atrial Fibrillation (PAF) 46/516 (8.9%) 47
    Arrhythmia - Permanent Atrial Fibrillation 4/516 (0.8%) 4
    Arrhythmia - Persistant Atrial Fibrillaiton 15/516 (2.9%) 15
    Arrhythmia - Tachycardia - Ventricular 1/516 (0.2%) 1
    Cardiovascular - Other 1/516 (0.2%) 1
    Heart Failure - Chronic (CHF) 2/516 (0.4%) 2
    Hypertension - Systemic 1/516 (0.2%) 1
    Pericardial Effusion - Minor 3/516 (0.6%) 3
    Thromboembolic Event - Other - Peripheral - Hemiparesis 1/516 (0.2%) 1
    Thromboembolic Event - Stroke 1/516 (0.2%) 1
    Thromboembolic Event - Transient Ischemic Attack (TIA) 3/516 (0.6%) 3
    Endocrine disorders
    Endocrine complications 1/516 (0.2%) 1
    Eye disorders
    Vision disorder 3/516 (0.6%) 3
    Gastrointestinal disorders
    Biliary (Gallbladder) 1/516 (0.2%) 1
    Gastrointestinal - Other 7/516 (1.4%) 7
    General disorders
    Allergic Reaction - Medication related 1/516 (0.2%) 1
    Cancer - Newly diagnosed 2/516 (0.4%) 2
    NSD - Paravalvular Leak - +2 2/516 (0.4%) 2
    NSD - Paravalvular leak with Hemolysis 1/516 (0.2%) 1
    Nonspecific, Unknown, or Other Body System - Other complication 3/516 (0.6%) 3
    Hepatobiliary disorders
    Hepatic complication - Other 1/516 (0.2%) 1
    Infections and infestations
    Infection /Inflammation - Other 3/516 (0.6%) 3
    Wound Infection - Other 6/516 (1.2%) 6
    Musculoskeletal and connective tissue disorders
    Bone Fracture/Break 1/516 (0.2%) 1
    Muscular Skeletal / Dermatologic - Other 14/516 (2.7%) 15
    Sternal Wound/Thoracic Infection 2/516 (0.4%) 2
    Psychiatric disorders
    Psychiatric - Other 6/516 (1.2%) 6
    Psychiatric Disorder 1/516 (0.2%) 1
    Transient Psychotic Syndrome 5/516 (1%) 5
    Renal and urinary disorders
    Renal Dysfunction 6/516 (1.2%) 6
    Renal Failure - Acute 2/516 (0.4%) 2
    Urinary Tract Infection (UTI) 15/516 (2.9%) 15
    Respiratory, thoracic and mediastinal disorders
    Pleural Effusion - Bilateral 6/516 (1.2%) 6
    Pleural Effusion - Left 2/516 (0.4%) 2
    Pneumothorax 1/516 (0.2%) 1
    Pulmonary/Respiratory - Other 5/516 (1%) 5
    Respiratory Dysfunction/Insufficiency 1/516 (0.2%) 1
    Respiratory Failure -COPD 1/516 (0.2%) 1
    Respiratory Infection - Pneumonia 2/516 (0.4%) 2
    Respiratory Infection - Upper (URI) 4/516 (0.8%) 4
    Vascular disorders
    Vascular - Deep Vein Thrombosis (DVT) 1/516 (0.2%) 1
    Vascular - Other 1/516 (0.2%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 30 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 60 day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.

    Results Point of Contact

    Name/Title Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart
    Organization Edwards Lifesciences, LLC
    Phone 949-250-2500 ext 0225
    Email Andrey_Nersesov@edwards.com
    Responsible Party:
    Edwards Lifesciences
    ClinicalTrials.gov Identifier:
    NCT02338154
    Other Study ID Numbers:
    • 2011-13
    First Posted:
    Jan 14, 2015
    Last Update Posted:
    Nov 22, 2019
    Last Verified:
    Nov 1, 2019