EDWARDS INTUITY Valve System CADENCE-MIS Study

A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve Replacement Using Minimally InvaSive Techniques

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02672553

Acronym

CADENCE-MIS

Enrollment

100

Registered

2016-02-03

Start date

2012-05-31

Completion date

2015-08-31

Last updated

2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Aortic Stenosis

Keywords

Aortic Valve Replacement, Minimal Invasive Sternotomy

Brief summary

The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.

Detailed description

This is a randomized study to compare the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system in a minimally invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach, in patients with logistic EuroScore \< 20 undergoing elective isolated aortic valve replacement (AVR) surgery. Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and to explore additional healthcare resource utilization endpoints.

Interventions

DEVICEEDWARDS INTUITY Valve System, Model 8300A

To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing MIS-AVR.

DEVICEStented Aortic Bioprostheses

In comparison to control valves available on the market undergoing FS-AVR

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion: 1. adult male or female ≥18 years of age 2. symptomatic for aortic stenosis / mixed aortic stenosis and aortic insufficiency disease for which isolated surgical aortic valve replacement without concomitant procedures is planned 3. EuroSCORE \<20 4. NYHA Class ≥II 5. Subject has signed and dated the investigation informed consent form prior to study specific procedures are performed 6. Subject is geographically stable and agrees to participate in follow-up assessments as specified in the protocol and informed consent Exclusion (i.a.): 1. pure aortic insufficiency 2. previous cardiac surgery (involved FS or MIS approach) 3. congenital true bicuspid / unicuspid aortic valve 4. requires emergency surgery or has had emergency surgery for any reason ≤ 1 month before the intended treatment 5. LVEF \<25% 6. active endocarditis ≤ 6 months before the intended treatment 7. acute MI ≤ 90 days before the intended treatment 8. had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery 9. oxygen or ventilator dependent 10. life expectancy \< 12 months 11. substance abuser 12. Female subject is pregnant or lactating 13. documented leukopenia (WBC \< 3.5x 103/μL), acute anemia (Hgb \< 10.0 gm/dL or \< 6.2 mmol/L), thrombocytopenia (platelet count \< 100x 103/mL), or history of bleeding diathesis or coagulopathy 14. hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure 15. documented echocardiographic evidence of intracardiac mass, thrombus or vegetation 16. renal insufficiency as determined by Serum creatinine ≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis 17. documented hyperparathyroidism 18. currently participating in an investigational drug or device trial for which follow-up has not yet been completed 19. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition Intra-operative Exclusion: 1. has calcium on the anterior mitral leaflet which cannot be removed 2. has extensive calcification of the aortic root 3. Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus 4. has left atrial thrombus 5. The position of the coronary ostia relative to the EDWARDS INTUITY Valve would result in obstruction of blood flow 6. hemodynamically unstable during the procedure requiring the procedure to be aborted prior to insertion of the study bioprosthesis and delivery system 7. Study device is not available in the correct size for the subject

Design outcomes

Primary

Measure	Time frame	Description
Median Subject 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.
Median Amount of Time Subject Spent on Cardiopulmonary Bypass	At time of surgery; an average of 1 hour	Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.

Secondary

Measure	Time frame	Description
Subject's Average Peak Gradients (mmHg) Measurements Over Time.	Baseline, Discharge, 30 days, 3 Months, 1 Year	Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
Subject's Effective Orifice Area (EOA) Measurement Over Time.	Baseline, Discharge, 30 days, 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.
Amount of Paravalvular Leak Over Time.	Discharge, 30 days, 3 month, 1 year	Number of subjects who experienced a Paravalvular Leak shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 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.
Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery.	Prior to Surgery	Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.
Subjects Who Required a Thoracic Resternotomy Over Time	30 days, 3 Months, 1 Year, 2 Years.	Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.
Subjects Who Received a Permanent Pacemaker Over Time.	30 days, 3 Months, 1 Year, 2 Years.	Number of Subjects who received a Permanent Pacemaker shown over various time points.
Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time	30 days, 3 Months, 1 Year, 2 Years.	Number of subjects who experienced a Paravalvular Leak shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Subjects Who Experienced Major Bleeding Over Time.	30 days, 3 Months, 1 Year, 2 Years.	Number of subjects who experienced Major Bleeding shown over various time points.
Subjects Who Experienced Respiratory Failure Over Time	30 days, 3 Months, 1 Year, 2 Years.	Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood.
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time	30 days, 3 Months, 1 Year, 2 Years.	Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.
Subjects With Renal Failure Over Time	30 days, 3 Months, 1 Year, 2 Years.	Number of subjects who experienced Renal (kidney) Failure shown over various time points.
Subjects With Endocarditis Over Time	30 days, 3 Months, 1 Year, 2 Years.	Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves.
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.	Baseline and 2 Years.	The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
Subjects With a Myocardial Infarction Over Time	30 days, 3 Months, 1 Year, 2 Years.	Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.
Subjects With a Thromboembolism Over Time	30 days, 3 Months, 1 Year, 2 Years.	Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation.
Subjects With a Cardiac Tamponade Over Time	30 days, 3 Months, 1 Year, 2 Years.	Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart.
Subjects With a Cardiac Reoperation for Any Reason Over Time	30 days, 3 Months, 1 Year, 2 Years.	Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.
Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery.	Prior to Surgery	Subjects Randomized to Edwards INTUITY Group's Surgical Aortic Valve undergoing Minimally Invasive Surgical incision being converted to a Full Sternotomy open procedure During Surgery.
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time	Baseline, 30 days, 3 Months, 1 Year	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 Score SF-12 - Quality of Life Questionnaire Over Time	Baseline, 30 days, 3 Months, 1 Year	Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12. The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS). The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time	Baseline, 30 days, 3 Months, 1 Year	The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at Baseline, 30 days, 3 Months,and 1 Year.
Health Care Utilization	Day of surgical procedure through discharge from the hospital, an average of 1.5 weeks	The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure.
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.	Baseline, Discharge, 30 days, 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.
Amount of Aortic Valvular Regurgitation Over Time.	Discharge, 30 days, 3 month, 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. Higher numbers on the scale show a worsening outcome.
Subjects With a Deep Sternal Would Infection Over Time	30 days, 3 Months, 1 Year, 2 Years.	Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.
Subject's Average Mean Gradients (mmHg) Measurements Over Time.	Baseline, Discharge, 30 days, 3 Months, 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.

Countries

Germany

Participant flow

Recruitment details

All eligible subjects recruited were randomized to each arm/group as 1:1 ratio at start.

Pre-assignment details

Three (3) of the subjects randomized to the Edwards INTUITY group were converted to the control group and received a commercially available surgical aortic heart valve via MIS and therefore these three (3) subjects could not be accurately categorized into the MIS-AVR or FS-AVR category and were excluded from the as intended (AI) cohort.

Participants by arm

Arm	Count
Edwards INTUITY Surgical Aortic Heart Valve Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	46
Control Group - Commercial Surgical Aortic Heart Valve Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR	48
Total	94

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Conversion to Commercial Valve	3	0
Overall Study	Death	3	5
Overall Study	Intraoperative screen failure	2	0
Overall Study	Valve Explant	1	0
Overall Study	Withdrawal by Subject	3	3

Baseline characteristics

Characteristic	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve	Total
Age, Continuous	73.0 Years STANDARD_DEVIATION 5.3	74.2 Years STANDARD_DEVIATION 5	73.61 Years STANDARD_DEVIATION 5.17
Region of Enrollment Europe	46 Participants	48 Participants	94 Participants
Sex: Female, Male Female	19 Participants	27 Participants	46 Participants
Sex: Female, Male Male	27 Participants	21 Participants	48 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	4 / 49	4 / 48
other Total, other adverse events	27 / 49	30 / 48
serious Total, serious adverse events	31 / 49	27 / 48

Outcome results

Primary

Median Amount of Time Subject Spent on Cardiopulmonary Bypass

Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.

Time frame: At time of surgery; an average of 1 hour

Population: The outcome is reported for subjects where data is available. Analysis is based on the AI cohort

Arm	Measure	Value (MEDIAN)
Edwards INTUITY Surgical Aortic Heart Valve	Median Amount of Time Subject Spent on Cardiopulmonary Bypass	58.5 Minutes
Control Group - Commercial Surgical Aortic Heart Valve	Median Amount of Time Subject Spent on Cardiopulmonary Bypass	69.0 Minutes

p-value: 0.2077Wilcoxon (Mann-Whitney)

Primary

Median Subject Time Spent on Cardiopulmonary Cross Clamp

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

Time frame: At time of surgery; an average of 1 hour

Population: The outcome is reported for subjects where data is available. Analysis is based on the AI cohort

Arm	Measure	Value (MEDIAN)
Edwards INTUITY Surgical Aortic Heart Valve	Median Subject Time Spent on Cardiopulmonary Cross Clamp	35.0 Minutes
Control Group - Commercial Surgical Aortic Heart Valve	Median Subject Time Spent on Cardiopulmonary Cross Clamp	47.5 Minutes

p-value: <0.0001Wilcoxon (Mann-Whitney)

Secondary

Amount of Aortic Valvular Regurgitation Over Time.

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

Time frame: Discharge, 30 days, 3 month, 1 year

Population: The outcome is reported for subjects where data is available. Analysis is based on the AI cohort

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	Discharge	0 None	29 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	Discharge	+1 Trivial/Trace	10 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	Discharge	+2 Mild	1 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	Discharge	+3 Moderate	0 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	Discharge	+4 Severe	0 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	30 days	0 None	25 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	30 days	+1 Trivial/Trace	10 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	30 days	+2 Mild	0 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	30 days	+3 Moderate	0 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	30 days	+4 Severe	0 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	3 months	0 None	27 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	3 months	+1 Trivial/Trace	13 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	3 months	+2 Mild	2 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	3 months	+3 Moderate	1 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	3 months	+4 Severe	0 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	1 year	0 None	25 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	1 year	+1 Trivial/Trace	10 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	1 year	+2 Mild	5 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	1 year	+3 Moderate	0 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	1 year	+4 Severe	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	1 year	+2 Mild	1 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	Discharge	0 None	29 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	3 months	0 None	25 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	Discharge	+1 Trivial/Trace	13 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	1 year	0 None	28 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	Discharge	+2 Mild	2 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	3 months	+1 Trivial/Trace	13 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	Discharge	+3 Moderate	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	1 year	+4 Severe	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	Discharge	+4 Severe	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	3 months	+2 Mild	2 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	30 days	0 None	29 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	1 year	+1 Trivial/Trace	11 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	30 days	+1 Trivial/Trace	6 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	3 months	+3 Moderate	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	30 days	+2 Mild	3 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	1 year	+3 Moderate	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	30 days	+3 Moderate	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	3 months	+4 Severe	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Aortic Valvular Regurgitation Over Time.	30 days	+4 Severe	0 Participants

Secondary

Amount of Paravalvular Leak Over Time.

Number of subjects who experienced a Paravalvular Leak shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 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, 30 days, 3 month, 1 year

Population: The outcome is reported for subjects where data is available. Analysis is based on the AI cohort

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	Discharge	0 None	30 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	Discharge	+1 Trivial/Trace	10 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	Discharge	+2 Mild	1 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	Discharge	+3 Moderate	0 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	Discharge	+4 Severe	0 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	30 days	0 None	27 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	30 days	+1 Trivial/Trace	6 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	30 days	+2 Mild	1 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	30 days	+3 Moderate	0 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	30 days	+4 Severe	0 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	3 months	0 None	26 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	3 months	+1 Trivial/Trace	13 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	3 months	+2 Mild	2 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	3 months	+3 Moderate	1 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	3 months	+4 Severe	0 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	1 year	0 None	23 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	1 year	+1 Trivial/Trace	9 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	1 year	+2 Mild	3 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	1 year	+3 Moderate	1 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	1 year	+4 Severe	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	1 year	+2 Mild	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	Discharge	0 None	33 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	3 months	0 None	27 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	Discharge	+1 Trivial/Trace	7 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	1 year	0 None	34 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	Discharge	+2 Mild	3 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	3 months	+1 Trivial/Trace	9 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	Discharge	+3 Moderate	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	1 year	+4 Severe	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	Discharge	+4 Severe	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	3 months	+2 Mild	3 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	30 days	0 None	24 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	1 year	+1 Trivial/Trace	6 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	30 days	+1 Trivial/Trace	11 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	3 months	+3 Moderate	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	30 days	+2 Mild	1 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	1 year	+3 Moderate	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	30 days	+3 Moderate	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	3 months	+4 Severe	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Amount of Paravalvular Leak Over Time.	30 days	+4 Severe	0 Participants

Secondary

Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery.

Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.

Time frame: Prior to Surgery

Population: Analysis is based on the ITT cohort

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Edwards INTUITY Surgical Aortic Heart Valve	Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery.	3 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery.	0 Participants

Secondary

Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery.

Subjects Randomized to Edwards INTUITY Group's Surgical Aortic Valve undergoing Minimally Invasive Surgical incision being converted to a Full Sternotomy open procedure During Surgery.

Time frame: Prior to Surgery

Population: Analysis is based on the ITT cohort

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Edwards INTUITY Surgical Aortic Heart Valve	Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery.	0 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery.	0 Participants

Secondary

Health Care Utilization

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

Time frame: Day of surgical procedure through discharge from the hospital, an average of 1.5 weeks

Population: This outcome is reported for subjects where data is available. Analysis is based on the ITT cohort

Arm	Measure	Group	Value (MEAN)	Dispersion
Edwards INTUITY Surgical Aortic Heart Valve	Health Care Utilization	Length of stay	10.9 Days	Standard Deviation 7
Edwards INTUITY Surgical Aortic Heart Valve	Health Care Utilization	ICU Length of stay	2.6 Days	Standard Deviation 5.4
Edwards INTUITY Surgical Aortic Heart Valve	Health Care Utilization	Intermediate Care Length of stay	1.3 Days	Standard Deviation 1.7
Control Group - Commercial Surgical Aortic Heart Valve	Health Care Utilization	Length of stay	11.5 Days	Standard Deviation 9.2
Control Group - Commercial Surgical Aortic Heart Valve	Health Care Utilization	ICU Length of stay	1.6 Days	Standard Deviation 1.5
Control Group - Commercial Surgical Aortic Heart Valve	Health Care Utilization	Intermediate Care Length of stay	0.9 Days	Standard Deviation 1.3

Secondary

Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.

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

Time frame: Baseline and 2 Years.

Population: The outcome is reported for subjects where data is available. Analysis is based on the ITT cohort

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Edwards INTUITY Surgical Aortic Heart Valve	Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.	Improved	22 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.	Same	17 Participants
Edwards INTUITY Surgical Aortic Heart Valve	Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.	Worsened	1 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.	Improved	27 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.	Same	11 Participants
Control Group - Commercial Surgical Aortic Heart Valve	Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.	Worsened	1 Participants

Secondary

Subject's Average Mean Gradients (mmHg) Measurements Over Time.

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

Time frame: Baseline, Discharge, 30 days, 3 Months, 1 Year

Population: The outcome is reported for subjects where data is available. Analysis is based on the AI cohort

Arm	Measure	Group	Value (MEAN)	Dispersion
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Mean Gradients (mmHg) Measurements Over Time.	3 months	9.1 mmHg	Standard Deviation 4.2
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Mean Gradients (mmHg) Measurements Over Time.	Baseline	44.0 mmHg	Standard Deviation 15.9
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Mean Gradients (mmHg) Measurements Over Time.	Discharge	10.3 mmHg	Standard Deviation 5.4
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Mean Gradients (mmHg) Measurements Over Time.	30 days	8.8 mmHg	Standard Deviation 4.2
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Mean Gradients (mmHg) Measurements Over Time.	1 year	9.1 mmHg	Standard Deviation 2.9
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Mean Gradients (mmHg) Measurements Over Time.	1 year	11.5 mmHg	Standard Deviation 4.3
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Mean Gradients (mmHg) Measurements Over Time.	30 days	9.7 mmHg	Standard Deviation 3.9
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Mean Gradients (mmHg) Measurements Over Time.	Baseline	45.4 mmHg	Standard Deviation 20
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Mean Gradients (mmHg) Measurements Over Time.	3 months	10.3 mmHg	Standard Deviation 4.8
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Mean Gradients (mmHg) Measurements Over Time.	Discharge	10.8 mmHg	Standard Deviation 3.4

Secondary

Subject's Average Peak Gradients (mmHg) Measurements Over Time.

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

Time frame: Baseline, Discharge, 30 days, 3 Months, 1 Year

Population: The outcome is reported for subjects where data is available. Analysis is based on the AI cohort

Arm	Measure	Group	Value (MEAN)	Dispersion
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Peak Gradients (mmHg) Measurements Over Time.	Discharge	19.0 mmHg	Standard Deviation 9.5
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Peak Gradients (mmHg) Measurements Over Time.	3 months	17.0 mmHg	Standard Deviation 7.6
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Peak Gradients (mmHg) Measurements Over Time.	30 days	16.5 mmHg	Standard Deviation 7.8
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Peak Gradients (mmHg) Measurements Over Time.	1 year	16.9 mmHg	Standard Deviation 5.3
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Peak Gradients (mmHg) Measurements Over Time.	Baseline	69.6 mmHg	Standard Deviation 23.7
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Peak Gradients (mmHg) Measurements Over Time.	1 year	21.9 mmHg	Standard Deviation 8.6
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Peak Gradients (mmHg) Measurements Over Time.	Baseline	75.4 mmHg	Standard Deviation 27.9
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Peak Gradients (mmHg) Measurements Over Time.	Discharge	21.0 mmHg	Standard Deviation 6.9
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Peak Gradients (mmHg) Measurements Over Time.	30 days	17.8 mmHg	Standard Deviation 6.5
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Peak Gradients (mmHg) Measurements Over Time.	3 months	18.9 mmHg	Standard Deviation 8.2

Secondary

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, 30 days, 3 Months, 1 Year

Population: The outcome is reported where data is available. Analysis is based on the ITT cohort

Arm	Measure	Group	Value (MEAN)	Dispersion
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time	Baseline	0.900 units on a scale	Standard Deviation 0.097
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time	30 day	0.862 units on a scale	Standard Deviation 0.08
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time	3 month	0.908 units on a scale	Standard Deviation 0.08
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time	1 year	0.922 units on a scale	Standard Deviation 0.086
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time	1 year	0.925 units on a scale	Standard Deviation 0.086
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time	Baseline	0.902 units on a scale	Standard Deviation 0.087
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time	3 month	0.918 units on a scale	Standard Deviation 0.077
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time	30 day	0.902 units on a scale	Standard Deviation 0.094

Secondary

Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at Baseline, 30 days, 3 Months,and 1 Year.

Time frame: Baseline, 30 days, 3 Months, 1 Year

Population: The outcome is reported where data is available. Analysis is based on the ITT cohort

Arm	Measure	Group	Value (MEAN)	Dispersion
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time	Baseline	58.37 units on a scale	Standard Deviation 24.79
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time	30 day	57.81 units on a scale	Standard Deviation 23.64
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time	3 month	69.32 units on a scale	Standard Deviation 23.58
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time	1 year	73.85 units on a scale	Standard Deviation 21.25
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time	1 year	78.11 units on a scale	Standard Deviation 21.05
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time	Baseline	61.33 units on a scale	Standard Deviation 24.2
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time	3 month	76.35 units on a scale	Standard Deviation 19.91
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time	30 day	64.33 units on a scale	Standard Deviation 24.9

Secondary

Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time

Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12. The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS). The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.

Time frame: Baseline, 30 days, 3 Months, 1 Year

Population: The outcome is reported where data is available. Analysis is based on the ITT cohort

Arm	Measure	Group	Value (MEAN)	Dispersion
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	PCS - Baseline	42.39 units on a scale	Standard Deviation 9.18
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	PCS - 30 day	36.16 units on a scale	Standard Deviation 10.08
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	PCS - 3 month	41.42 units on a scale	Standard Deviation 8.19
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	PCS - 1 year	43.84 units on a scale	Standard Deviation 9.46
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	MCS - Baseline	48.02 units on a scale	Standard Deviation 12.85
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	MCS - 30 day	48.06 units on a scale	Standard Deviation 12.88
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	MCS - 3 month	49.87 units on a scale	Standard Deviation 11.28
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	MCS - 1 year	51.08 units on a scale	Standard Deviation 8.8
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	MCS - 1 year	52.46 units on a scale	Standard Deviation 8.58
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	PCS - Baseline	40.79 units on a scale	Standard Deviation 9.96
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	MCS - Baseline	50.07 units on a scale	Standard Deviation 11.8
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	PCS - 30 day	38.45 units on a scale	Standard Deviation 7.86
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	MCS - 3 month	51.37 units on a scale	Standard Deviation 9.76
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	PCS - 3 month	43.95 units on a scale	Standard Deviation 7.88
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	MCS - 30 day	50.26 units on a scale	Standard Deviation 11.78
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	PCS - 1 year	44.70 units on a scale	Standard Deviation 8.39

Secondary

Subject's Effective Orifice Area (EOA) Measurement Over Time.

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

Time frame: Baseline, Discharge, 30 days, 3 Months, 1 Year

Population: The outcome is reported for subjects where data is available. Analysis is based on the AI cohort

Arm	Measure	Group	Value (MEAN)	Dispersion
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Effective Orifice Area (EOA) Measurement Over Time.	Discharge	1.9 centimeters squared	Standard Deviation 0.6
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Effective Orifice Area (EOA) Measurement Over Time.	3 months	1.9 centimeters squared	Standard Deviation 0.5
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Effective Orifice Area (EOA) Measurement Over Time.	30 days	1.9 centimeters squared	Standard Deviation 0.5
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Effective Orifice Area (EOA) Measurement Over Time.	1 year	1.9 centimeters squared	Standard Deviation 0.5
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Effective Orifice Area (EOA) Measurement Over Time.	Baseline	0.7 centimeters squared	Standard Deviation 0.2
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Effective Orifice Area (EOA) Measurement Over Time.	1 year	1.7 centimeters squared	Standard Deviation 0.4
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Effective Orifice Area (EOA) Measurement Over Time.	Baseline	0.7 centimeters squared	Standard Deviation 0.2
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Effective Orifice Area (EOA) Measurement Over Time.	Discharge	1.9 centimeters squared	Standard Deviation 0.7
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Effective Orifice Area (EOA) Measurement Over Time.	30 days	2.0 centimeters squared	Standard Deviation 0.7
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Effective Orifice Area (EOA) Measurement Over Time.	3 months	1.8 centimeters squared	Standard Deviation 0.6

Secondary

Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.

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

Time frame: Baseline, Discharge, 30 days, 3 Months, 1 Year

Population: The outcome is reported for subjects where data is available. Analysis is based on the AI cohort

Arm	Measure	Group	Value (MEAN)	Dispersion
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.	Discharge	0.9 centimeters squared/meters squared	Standard Deviation 0.3
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.	3 months	1.0 centimeters squared/meters squared	Standard Deviation 0.2
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.	30 days	1.0 centimeters squared/meters squared	Standard Deviation 0.3
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.	1 year	1.0 centimeters squared/meters squared	Standard Deviation 0.3
Edwards INTUITY Surgical Aortic Heart Valve	Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.	Baseline	0.4 centimeters squared/meters squared	Standard Deviation 0.1
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.	1 year	0.9 centimeters squared/meters squared	Standard Deviation 0.2
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.	Baseline	0.4 centimeters squared/meters squared	Standard Deviation 0.1
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.	Discharge	1.0 centimeters squared/meters squared	Standard Deviation 0.4
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.	30 days	1.1 centimeters squared/meters squared	Standard Deviation 0.3
Control Group - Commercial Surgical Aortic Heart Valve	Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.	3 months	1.0 centimeters squared/meters squared	Standard Deviation 0.3

Secondary