EDWARDS INTUITY Valve System CADENCE-MIS Study

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02672553
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease; Aortic Stenosis	Device: EDWARDS INTUITY Valve System, Model 8300A; Device: Stented Aortic Bioprostheses	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: EDWARDS INTUITY EDWARDS INTUITY Valve System, Model 8300A	Device: EDWARDS 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.; Other Names: aortic stenosis stenosis-based insufficiency aortic valve replacement
Active Comparator: Stented Aortic Bioprostheses Stented Aortic Bioprostheses	Device: Stented Aortic Bioprostheses; In comparison to control valves available on the market undergoing FS-AVR; Other Names: aortic stenosis stenosis-based insufficiency aortic valve replacement

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. 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.

Eligibility Criteria

Criteria

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

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

1. LVEF <25%

2. active endocarditis ≤ 6 months before the intended treatment

3. acute MI ≤ 90 days before the intended treatment

4. had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery

5. oxygen or ventilator dependent

6. life expectancy < 12 months

7. substance abuser

8. Female subject is pregnant or lactating

9. 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

10. hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure

11. documented echocardiographic evidence of intracardiac mass, thrombus or vegetation

12. renal insufficiency as determined by Serum creatinine ≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis

13. documented hyperparathyroidism

14. currently participating in an investigational drug or device trial for which follow-up has not yet been completed

15. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leipzig Heart Center	Leipzig	Saxony	Germany	04289

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

• Principal Investigator: Prof. Borger, MD, Leipzig Heart Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• New York Heart Association Classification
• EuroQol Standardized Instrument (EQ-5D) developed to measure of health-related quality of life.
• Short Form Health Survey (SF-12) with 12 questions to measure functional health and well-being of patient's quality of life

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT02672553
• Other Study ID Numbers: 2011-12
• First Posted: Feb 3, 2016
• Last Update Posted: Jan 28, 2019
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Edwards Lifesciences: Aortic Valve Replacement; Minimal Invasive Sternotomy
• Additional relevant MeSH terms: Aortic Valve Stenosis; Aortic Valve Disease

Study Results

Participant Flow

Recruitment Details	All eligible subjects recruited were randomized to each arm/group as 1:1 ratio at start.
Pre-assignment Detail	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.

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Period Title: Overall Study
STARTED	51	49
Intent To Treated (ITT) Randomized Arm	49	48
As Treated (AT) Randomized Arm/Group	46	51
As Intended (AI) Randomized Arm/Group	46	48
COMPLETED	39	41
NOT COMPLETED	12	8

Baseline Characteristics

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve	Total
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR	Total of all reporting groups
Overall Participants	46	48	94
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	73.0 (5.3)	74.2 (5.0)	73.61 (5.17)
Sex: Female, Male (Count of Participants)
Female	19 41.3%	27 56.3%	46 48.9%
Male	27 58.7%	21 43.8%	48 51.1%
Region of Enrollment (Count of Participants)
Europe	46 100%	48 100%	94 100%

Outcome Measures

1. Primary Outcome

Title	Median Subject 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

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
Median (Full Range) [Minutes]	35.0	47.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Edwards INTUITY Surgical Aortic Heart Valve, Control Group - Commercial Surgical Aortic Heart Valve
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-12.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Median Amount of Time Subject 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 hour

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
Median (Full Range) [Minutes]	58.5	69.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Edwards INTUITY Surgical Aortic Heart Valve, Control Group - Commercial Surgical Aortic Heart Valve
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2077
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-10.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	40	39
Improved	22 47.8%	27 56.3%
Same	17 37%	11 22.9%
Worsened	1 2.2%	1 2.1%

4. Secondary Outcome

Title	Subject's Average Mean Gradients (mmHg) Measurements Over Time.
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, 30 days, 3 Months, 1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
Baseline	44.0 (15.9)	45.4 (20.0)
Discharge	10.3 (5.4)	10.8 (3.4)
30 days	8.8 (4.2)	9.7 (3.9)
3 months	9.1 (4.2)	10.3 (4.8)
1 year	9.1 (2.9)	11.5 (4.3)

5. Secondary 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, 30 days, 3 Months, 1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
Baseline	69.6 (23.7)	75.4 (27.9)
Discharge	19.0 (9.5)	21.0 (6.9)
30 days	16.5 (7.8)	17.8 (6.5)
3 months	17.0 (7.6)	18.9 (8.2)
1 year	16.9 (5.3)	21.9 (8.6)

6. Secondary Outcome

Title	Subject's Effective Orifice Area (EOA) Measurement Over Time.
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, 30 days, 3 Months, 1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
Baseline	0.7 (0.2)	0.7 (0.2)
Discharge	1.9 (0.6)	1.9 (0.7)
30 days	1.9 (0.5)	2.0 (0.7)
3 months	1.9 (0.5)	1.8 (0.6)
1 year	1.9 (0.5)	1.7 (0.4)

7. Secondary Outcome

Title	Amount of Paravalvular Leak Over Time.
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
0 None	30 65.2%	33 68.8%
+1 Trivial/Trace	10 21.7%	7 14.6%
+2 Mild	1 2.2%	3 6.3%
+3 Moderate	0 0%	0 0%
+4 Severe	0 0%	0 0%
0 None	27 58.7%	24 50%
+1 Trivial/Trace	6 13%	11 22.9%
+2 Mild	1 2.2%	1 2.1%
+3 Moderate	0 0%	0 0%
+4 Severe	0 0%	0 0%
0 None	26 56.5%	27 56.3%
+1 Trivial/Trace	13 28.3%	9 18.8%
+2 Mild	2 4.3%	3 6.3%
+3 Moderate	1 2.2%	0 0%
+4 Severe	0 0%	0 0%
0 None	23 50%	34 70.8%
+1 Trivial/Trace	9 19.6%	6 12.5%
+2 Mild	3 6.5%	0 0%
+3 Moderate	1 2.2%	0 0%
+4 Severe	0 0%	0 0%

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Analysis is based on the ITT cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	49	48
Count of Participants [Participants]	3 6.5%	0 0%

9. Secondary Outcome

Title	Subjects Who Required a Thoracic Resternotomy Over Time
Description	Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	6 13%	5 10.4%
3 months	6 13%	5 10.4%
1 year	7 15.2%	5 10.4%
2 year	7 15.2%	5 10.4%

10. Secondary Outcome

Title	Subjects Who Received a Permanent Pacemaker Over Time.
Description	Number of Subjects who received a Permanent Pacemaker shown over various time points.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	2 4.3%	1 2.1%
3 months	2 4.3%	1 2.1%
1 year	2 4.3%	1 2.1%
2 year	3 6.5%	2 4.2%

11. Secondary Outcome

Title	Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time
Description	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.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	0 0%	1 2.1%
3 months	0 0%	1 2.1%
1 year	2 4.3%	1 2.1%
2 year	2 4.3%	1 2.1%

12. Secondary Outcome

Title	Subjects Who Experienced Major Bleeding Over Time.
Description	Number of subjects who experienced Major Bleeding shown over various time points.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	8 17.4%	4 8.3%
3 months	8 17.4%	5 10.4%
1 year	8 17.4%	5 10.4%
2 year	8 17.4%	5 10.4%

13. Secondary Outcome

Title	Subjects Who Experienced Respiratory Failure Over Time
Description	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.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	2 4.3%	0 0%
3 months	2 4.3%	0 0%
1 year	2 4.3%	2 4.2%
2 year	2 4.3%	2 4.2%

14. Secondary Outcome

Title	Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
Description	Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	2 4.3%	2 4.2%
3 months	2 4.3%	2 4.2%
1 year	2 4.3%	2 4.2%
2 year	3 6.5%	2 4.2%

15. Secondary Outcome

Title	Subjects With Renal Failure Over Time
Description	Number of subjects who experienced Renal (kidney) Failure shown over various time points.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	3 6.5%	0 0%
3 months	3 6.5%	0 0%
1 year	3 6.5%	1 2.1%
2 year	3 6.5%	1 2.1%

16. Secondary Outcome

Title	Subjects With Endocarditis Over Time
Description	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.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	0 0%	0 0%
3 months	0 0%	0 0%
1 year	0 0%	0 0%
2 year	0 0%	0 0%

17. Secondary Outcome

Title	Subjects With a Deep Sternal Would Infection Over Time
Description	Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	1 2.2%	1 2.1%
3 months	1 2.2%	1 2.1%
1 year	1 2.2%	1 2.1%
2 year	1 2.2%	1 2.1%

18. Secondary Outcome

Title	Subjects With a Myocardial Infarction Over Time
Description	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.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	0 0%	1 2.1%
3 months	0 0%	1 2.1%
1 year	0 0%	2 4.2%
2 year	0 0%	2 4.2%

19. Secondary Outcome

Title	Subjects With a Thromboembolism Over Time
Description	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.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	3 6.5%	3 6.3%
3 months	3 6.5%	3 6.3%
1 year	4 8.7%	4 8.3%
2 year	5 10.9%	4 8.3%

20. Secondary Outcome

Title	Subjects With a Cardiac Tamponade Over Time
Description	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.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	2 4.3%	3 6.3%
3 months	2 4.3%	3 6.3%
1 year	2 4.3%	3 6.3%
2 year	2 4.3%	3 6.3%

21. Secondary Outcome

Title	Subjects With a Cardiac Reoperation for Any Reason Over Time
Description	Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.
Time Frame	30 days, 3 Months, 1 Year, 2 Years.

Outcome Measure Data

Analysis Population Description

Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
30 days	6 13%	5 10.4%
3 months	6 13%	5 10.4%
1 year	7 15.2%	6 12.5%
2 year	7 15.2%	6 12.5%

22. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Analysis is based on the ITT cohort

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	49	48
Count of Participants [Participants]	0 0%	0 0%

23. Secondary Outcome

Title	Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	49	48
Baseline	0.900 (0.097)	0.902 (0.087)
30 day	0.862 (0.080)	0.902 (0.094)
3 month	0.908 (0.080)	0.918 (0.077)
1 year	0.922 (0.086)	0.925 (0.086)

24. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	49	48
PCS - Baseline	42.39 (9.18)	40.79 (9.96)
PCS - 30 day	36.16 (10.08)	38.45 (7.86)
PCS - 3 month	41.42 (8.19)	43.95 (7.88)
PCS - 1 year	43.84 (9.46)	44.70 (8.39)
MCS - Baseline	48.02 (12.85)	50.07 (11.80)
MCS - 30 day	48.06 (12.88)	50.26 (11.78)
MCS - 3 month	49.87 (11.28)	51.37 (9.76)
MCS - 1 year	51.08 (8.80)	52.46 (8.58)

25. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	49	48
Baseline	58.37 (24.79)	61.33 (24.20)
30 day	57.81 (23.64)	64.33 (24.90)
3 month	69.32 (23.58)	76.35 (19.91)
1 year	73.85 (21.25)	78.11 (21.05)

26. Secondary Outcome

Title	Health Care Utilization
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	49	48
Length of stay	10.9 (7.0)	11.5 (9.2)
ICU Length of stay	2.6 (5.4)	1.6 (1.5)
Intermediate Care Length of stay	1.3 (1.7)	0.9 (1.3)

27. Secondary Outcome

Title	Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.
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, 30 days, 3 Months, 1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
Baseline	0.4 (0.1)	0.4 (0.1)
Discharge	0.9 (0.3)	1.0 (0.4)
30 days	1.0 (0.3)	1.1 (0.3)
3 months	1.0 (0.2)	1.0 (0.3)
1 year	1.0 (0.3)	0.9 (0.2)

28. Secondary Outcome

Title	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. Higher numbers on the scale show a worsening outcome.
Time Frame	Discharge, 30 days, 3 month, 1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve	Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Measure Participants	46	48
0 None	29 63%	29 60.4%
+1 Trivial/Trace	10 21.7%	13 27.1%
+2 Mild	1 2.2%	2 4.2%
+3 Moderate	0 0%	0 0%
+4 Severe	0 0%	0 0%
0 None	25 54.3%	29 60.4%
+1 Trivial/Trace	10 21.7%	6 12.5%
+2 Mild	0 0%	3 6.3%
+3 Moderate	0 0%	0 0%
+4 Severe	0 0%	0 0%
0 None	27 58.7%	25 52.1%
+1 Trivial/Trace	13 28.3%	13 27.1%
+2 Mild	2 4.3%	2 4.2%
+3 Moderate	1 2.2%	0 0%
+4 Severe	0 0%	0 0%
0 None	25 54.3%	28 58.3%
+1 Trivial/Trace	10 21.7%	11 22.9%
+2 Mild	5 10.9%	1 2.1%
+3 Moderate	0 0%	0 0%
+4 Severe	0 0%	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 ITT cohort
Arm/Group Title	Edwards INTUITY Surgical Aortic Heart Valve		Control Group - Commercial Surgical Aortic Heart Valve
Arm/Group Description	Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR		Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
All Cause Mortality
	Edwards INTUITY Surgical Aortic Heart Valve		Control Group - Commercial Surgical Aortic Heart Valve
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/49 (8.2%)		4/48 (8.3%)
Serious Adverse Events
	Edwards INTUITY Surgical Aortic Heart Valve		Control Group - Commercial Surgical Aortic Heart Valve
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/49 (63.3%)		27/48 (56.3%)
Blood and lymphatic system disorders
BLEEDING - CARDIOVASCULAR - MAJOR	4/49 (8.2%)		1/48 (2.1%)
BLEEDING - GASTROINTESTINAL UPPER -MAJOR	1/49 (2%)		0/48 (0%)
BLEEDING - NEUROLOGICAL - MAJOR (E.G. CVA)	1/49 (2%)		1/48 (2.1%)
BLEEDING - PERIPHERAL VASCULAR - MINOR (E.G. NOSEBLEEDS; HEMATOMAS)	1/49 (2%)		0/48 (0%)
Cardiac disorders
THROMBOEMBOLIC EVENT - OTHER - CENTRAL - NO PARESIS	0/49 (0%)		1/48 (2.1%)
THROMBOEMBOLIC EVENT - STROKE	2/49 (4.1%)		1/48 (2.1%)
THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)	2/49 (4.1%)		1/48 (2.1%)
ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)	4/49 (8.2%)		4/48 (8.3%)
ARRHYTHMIA - AV BLOCK - 3RD DEGREE	2/49 (4.1%)		2/48 (4.2%)
ARRHYTHMIA - BRADYCARDIA	0/49 (0%)		1/48 (2.1%)
ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLATION	1/49 (2%)		1/48 (2.1%)
ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT)	0/49 (0%)		1/48 (2.1%)
ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR	0/49 (0%)		1/48 (2.1%)
ARRHYTHMIA - TACHYCARDIA - VENTRICULAR	1/49 (2%)		0/48 (0%)
MYOCARDIAL INFARCTION	1/49 (2%)		2/48 (4.2%)
PERICARDIAL EFFUSION - MAJOR	3/49 (6.1%)		0/48 (0%)
PERICARDIAL TAMPONADE - MAJOR	2/49 (4.1%)		3/48 (6.3%)
CARDIAC DECOMPENSATION	1/49 (2%)		2/48 (4.2%)
CARDIAC ARREST	1/49 (2%)		0/48 (0%)
CARDIOVASCULAR - OTHER	2/49 (4.1%)		1/48 (2.1%)
CARDIOGENIC SHOCK	1/49 (2%)		0/48 (0%)
ENDOCARDITIS	0/49 (0%)		1/48 (2.1%)
PERICARDITIS	0/49 (0%)		1/48 (2.1%)
REGURGITATION - MITRAL-INDETERMINATE-+4	0/49 (0%)		1/48 (2.1%)
Gastrointestinal disorders
BILIARY (GALLBLADDER)	1/49 (2%)		2/48 (4.2%)
GASTROINTESTINAL - OTHER	3/49 (6.1%)		2/48 (4.2%)
GASTROINTESTINAL - INFECTION	1/49 (2%)		0/48 (0%)
General disorders
NSD - PARAVALVULAR LEAK - +4	1/49 (2%)		0/48 (0%)
NSD - PARAVALVULAR LEAK WITH HEMOLYSIS	1/49 (2%)		0/48 (0%)
CANCER - NEWLY DIAGNOSED	2/49 (4.1%)		1/48 (2.1%)
NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION	2/49 (4.1%)		3/48 (6.3%)
ALLERGIC REACTION - MEDICATION RELATED	0/49 (0%)		1/48 (2.1%)
MULTI-SYSTEM ORGAN FAILURE	1/49 (2%)		0/48 (0%)
Musculoskeletal and connective tissue disorders
MUSCULAR SKELETAL / DERMATOLOGIC - OTHER	2/49 (4.1%)		6/48 (12.5%)
STERNAL WOUND/THORACIC INFECTION	2/49 (4.1%)		2/48 (4.2%)
INFECTION /INFLAMMATION - OTHER	1/49 (2%)		0/48 (0%)
Psychiatric disorders
TRANSIENT PSYCHOTIC SYNDROME	1/49 (2%)		1/48 (2.1%)
Renal and urinary disorders
GENITOURINARY - OTHER	3/49 (6.1%)		0/48 (0%)
RENAL DYSFUNCTION	0/49 (0%)		1/48 (2.1%)
RENAL FAILURE - ACUTE	2/49 (4.1%)		1/48 (2.1%)
RENAL - OTHER	1/49 (2%)		0/48 (0%)
URINARY TRACT INFECTION (UTI)	1/49 (2%)		0/48 (0%)
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION - BILATERAL	5/49 (10.2%)		3/48 (6.3%)
RESPIRATORY INFECTION - PNEUMONIA	3/49 (6.1%)		2/48 (4.2%)
RESPIRATORY FAILURE -PNEUMONIA	1/49 (2%)		2/48 (4.2%)
PLEURAL EFFUSION - LEFT	2/49 (4.1%)		0/48 (0%)
RESPIRATORY FAILURE -COPD	1/49 (2%)		2/48 (4.2%)
Vascular disorders
VASCULAR - OTHER	2/49 (4.1%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Edwards INTUITY Surgical Aortic Heart Valve		Control Group - Commercial Surgical Aortic Heart Valve
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/49 (55.1%)		30/48 (62.5%)
Blood and lymphatic system disorders
ANEMIA - NON-BLEEDING RELATED	1/49 (2%)		2/48 (4.2%)
ANEMIA - BLEEDING RELATED - MINOR	0/49 (0%)		1/48 (2.1%)
BLEEDING - GASTROINTESTINAL LOWER -MINOR	1/49 (2%)		0/48 (0%)
BLEEDING - PULMONARY/RESPIRATORY MINOR (E.G. HEMOTHORAX)	1/49 (2%)		0/48 (0%)
BLOOD/ LYMPHATIC - OTHER	1/49 (2%)		0/48 (0%)
Cardiac disorders
ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)	4/49 (8.2%)		6/48 (12.5%)
ARRHYTHMIA - PERMANENT ATRIAL FIBRILLATION	0/49 (0%)		3/48 (6.3%)
PERICARDIAL EFFUSION - MINOR	3/49 (6.1%)		5/48 (10.4%)
THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)	0/49 (0%)		1/48 (2.1%)
ARRHYTHMIA - ATRIAL FLUTTER	1/49 (2%)		0/48 (0%)
ARRHYTHMIA - AV BLOCK - 1ST DEGREE	1/49 (2%)		1/48 (2.1%)
ARRHYTHMIA - AV BLOCK - 2ND DEGREE	0/49 (0%)		1/48 (2.1%)
ARRHYTHMIA - AV BLOCK - 3RD DEGREE	0/49 (0%)		1/48 (2.1%)
ARRHYTHMIA - BRADYCARDIA	1/49 (2%)		0/48 (0%)
ARRHYTHMIA - PAROXYSMAL ATRIAL TACHYCARDIA (PAT)	1/49 (2%)		0/48 (0%)
ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT)	1/49 (2%)		1/48 (2.1%)
ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLATION	0/49 (0%)		1/48 (2.1%)
ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR	1/49 (2%)		0/48 (0%)
CARDIOVASCULAR - OTHER	1/49 (2%)		1/48 (2.1%)
Gastrointestinal disorders
GASTROINTESTINAL - OTHER	1/49 (2%)		3/48 (6.3%)
GASTROINTESTINAL - INFECTION	1/49 (2%)		1/48 (2.1%)
General disorders
NSD - PARAVALVULAR LEAK - +1	1/49 (2%)		0/48 (0%)
NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION	1/49 (2%)		2/48 (4.2%)
Musculoskeletal and connective tissue disorders
MUSCULAR SKELETAL / DERMATOLOGIC - OTHER	5/49 (10.2%)		5/48 (10.4%)
WOUND INFECTION - OTHER	0/49 (0%)		1/48 (2.1%)
INFECTION /INFLAMMATION - OTHER	1/49 (2%)		0/48 (0%)
Psychiatric disorders
TRANSIENT PSYCHOTIC SYNDROME	2/49 (4.1%)		2/48 (4.2%)
Renal and urinary disorders
RENAL FAILURE - ACUTE	1/49 (2%)		2/48 (4.2%)
GENITOURINARY - OTHER	0/49 (0%)		1/48 (2.1%)
URINARY TRACT INFECTION (UTI)	2/49 (4.1%)		1/48 (2.1%)
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION - BILATERAL	2/49 (4.1%)		3/48 (6.3%)
PLEURAL EFFUSION - LEFT	2/49 (4.1%)		1/48 (2.1%)
PLEURAL EFFUSION - RIGHT	2/49 (4.1%)		1/48 (2.1%)
ATELECTASIS	1/49 (2%)		1/48 (2.1%)
PNEUMOTHORAX	2/49 (4.1%)		0/48 (0%)
PULMONARY/RESPIRATORY - OTHER	1/49 (2%)		0/48 (0%)
RESPIRATORY FAILURE -COPD	1/49 (2%)		0/48 (0%)
RESPIRATORY INFECTION - PNEUMONIA	1/49 (2%)		1/48 (2.1%)
RESPIRATORY FAILURE -OTHER	0/49 (0%)		1/48 (2.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

PI can't publish/present on overall study results not yet published but may publish his own data subject to EW review prior to submission/presentation, but data analyses of site-specific results can occur only in intervals as specified in the CTA. Publication/presentation of the PI's site-specific results of devices which haven't been market released and which still may be undergoing development, shall not include claims of device safety/effectiveness and will require the review/approval of EW.