Trial Outcomes & Findings for EDWARDS INTUITY Valve System CADENCE-MIS Study (NCT NCT02672553)

NCT ID: NCT02672553

Last Updated: 2019-01-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: At time of surgery; an average of 1 hour
• Results posted on: 2019-01-28

Participant Flow

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

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.

Participant milestones

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

Reasons for withdrawal

Measure	Edwards INTUITY Surgical Aortic Heart Valve Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Control Group - Commercial Surgical Aortic Heart Valve Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Overall Study Death	3	5
Overall Study Valve Explant	1	0
Overall Study Conversion to Commercial Valve	3	0
Overall Study Withdrawal by Subject	3	3
Overall Study Intraoperative screen failure	2	0

Baseline Characteristics

EDWARDS INTUITY Valve System CADENCE-MIS Study

Baseline characteristics by cohort

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR	Total n=94 Participants Total of all reporting groups
Age, Continuous	73.0 Years STANDARD_DEVIATION 5.3 • n=5 Participants	74.2 Years STANDARD_DEVIATION 5.0 • n=7 Participants	73.61 Years STANDARD_DEVIATION 5.17 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	27 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment Europe	46 Participants n=5 Participants	48 Participants n=7 Participants	94 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Median Subject Time Spent on Cardiopulmonary Cross Clamp	35.0 Minutes Interval 16.0 to 115.0	47.5 Minutes Interval 32.0 to 123.0

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Median Amount of Time Subject Spent on Cardiopulmonary Bypass	58.5 Minutes Interval 38.0 to 161.0	69.0 Minutes Interval 39.0 to 170.0

SECONDARY outcome

Timeframe: Baseline and 2 Years.

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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=40 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=39 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. Improved	22 Participants	27 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. Same	17 Participants	11 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. Worsened	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subject's Average Mean Gradients (mmHg) Measurements Over Time. Baseline	44.0 mmHg Standard Deviation 15.9	45.4 mmHg Standard Deviation 20.0
Subject's Average Mean Gradients (mmHg) Measurements Over Time. Discharge	10.3 mmHg Standard Deviation 5.4	10.8 mmHg Standard Deviation 3.4
Subject's Average Mean Gradients (mmHg) Measurements Over Time. 30 days	8.8 mmHg Standard Deviation 4.2	9.7 mmHg Standard Deviation 3.9
Subject's Average Mean Gradients (mmHg) Measurements Over Time. 3 months	9.1 mmHg Standard Deviation 4.2	10.3 mmHg Standard Deviation 4.8
Subject's Average Mean Gradients (mmHg) Measurements Over Time. 1 year	9.1 mmHg Standard Deviation 2.9	11.5 mmHg Standard Deviation 4.3

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subject's Average Peak Gradients (mmHg) Measurements Over Time. Baseline	69.6 mmHg Standard Deviation 23.7	75.4 mmHg Standard Deviation 27.9
Subject's Average Peak Gradients (mmHg) Measurements Over Time. Discharge	19.0 mmHg Standard Deviation 9.5	21.0 mmHg Standard Deviation 6.9
Subject's Average Peak Gradients (mmHg) Measurements Over Time. 30 days	16.5 mmHg Standard Deviation 7.8	17.8 mmHg Standard Deviation 6.5
Subject's Average Peak Gradients (mmHg) Measurements Over Time. 3 months	17.0 mmHg Standard Deviation 7.6	18.9 mmHg Standard Deviation 8.2
Subject's Average Peak Gradients (mmHg) Measurements Over Time. 1 year	16.9 mmHg Standard Deviation 5.3	21.9 mmHg Standard Deviation 8.6

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subject's Effective Orifice Area (EOA) Measurement Over Time. Discharge	1.9 centimeters squared Standard Deviation 0.6	1.9 centimeters squared Standard Deviation 0.7
Subject's Effective Orifice Area (EOA) Measurement Over Time. Baseline	0.7 centimeters squared Standard Deviation 0.2	0.7 centimeters squared Standard Deviation 0.2
Subject's Effective Orifice Area (EOA) Measurement Over Time. 30 days	1.9 centimeters squared Standard Deviation 0.5	2.0 centimeters squared Standard Deviation 0.7
Subject's Effective Orifice Area (EOA) Measurement Over Time. 3 months	1.9 centimeters squared Standard Deviation 0.5	1.8 centimeters squared Standard Deviation 0.6
Subject's Effective Orifice Area (EOA) Measurement Over Time. 1 year	1.9 centimeters squared Standard Deviation 0.5	1.7 centimeters squared Standard Deviation 0.4

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Amount of Paravalvular Leak Over Time. Discharge · 0 None	30 Participants	33 Participants
Amount of Paravalvular Leak Over Time. Discharge · +1 Trivial/Trace	10 Participants	7 Participants
Amount of Paravalvular Leak Over Time. Discharge · +2 Mild	1 Participants	3 Participants
Amount of Paravalvular Leak Over Time. Discharge · +3 Moderate	0 Participants	0 Participants
Amount of Paravalvular Leak Over Time. Discharge · +4 Severe	0 Participants	0 Participants
Amount of Paravalvular Leak Over Time. 30 days · 0 None	27 Participants	24 Participants
Amount of Paravalvular Leak Over Time. 30 days · +1 Trivial/Trace	6 Participants	11 Participants
Amount of Paravalvular Leak Over Time. 30 days · +2 Mild	1 Participants	1 Participants
Amount of Paravalvular Leak Over Time. 30 days · +3 Moderate	0 Participants	0 Participants
Amount of Paravalvular Leak Over Time. 30 days · +4 Severe	0 Participants	0 Participants
Amount of Paravalvular Leak Over Time. 3 months · 0 None	26 Participants	27 Participants
Amount of Paravalvular Leak Over Time. 3 months · +1 Trivial/Trace	13 Participants	9 Participants
Amount of Paravalvular Leak Over Time. 3 months · +2 Mild	2 Participants	3 Participants
Amount of Paravalvular Leak Over Time. 3 months · +3 Moderate	1 Participants	0 Participants
Amount of Paravalvular Leak Over Time. 3 months · +4 Severe	0 Participants	0 Participants
Amount of Paravalvular Leak Over Time. 1 year · 0 None	23 Participants	34 Participants
Amount of Paravalvular Leak Over Time. 1 year · +1 Trivial/Trace	9 Participants	6 Participants
Amount of Paravalvular Leak Over Time. 1 year · +2 Mild	3 Participants	0 Participants
Amount of Paravalvular Leak Over Time. 1 year · +3 Moderate	1 Participants	0 Participants
Amount of Paravalvular Leak Over Time. 1 year · +4 Severe	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Prior to Surgery

Population: Analysis is based on the ITT cohort

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

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery.	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects Who Required a Thoracic Resternotomy Over Time 30 days	6 Participants	5 Participants
Subjects Who Required a Thoracic Resternotomy Over Time 3 months	6 Participants	5 Participants
Subjects Who Required a Thoracic Resternotomy Over Time 1 year	7 Participants	5 Participants
Subjects Who Required a Thoracic Resternotomy Over Time 2 year	7 Participants	5 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

Number of Subjects who received a Permanent Pacemaker shown over various time points.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects Who Received a Permanent Pacemaker Over Time. 30 days	2 Participants	1 Participants
Subjects Who Received a Permanent Pacemaker Over Time. 3 months	2 Participants	1 Participants
Subjects Who Received a Permanent Pacemaker Over Time. 1 year	2 Participants	1 Participants
Subjects Who Received a Permanent Pacemaker Over Time. 2 year	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time 30 days	0 Participants	1 Participants
Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time 3 months	0 Participants	1 Participants
Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time 1 year	2 Participants	1 Participants
Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time 2 year	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

Number of subjects who experienced Major Bleeding shown over various time points.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects Who Experienced Major Bleeding Over Time. 30 days	8 Participants	4 Participants
Subjects Who Experienced Major Bleeding Over Time. 3 months	8 Participants	5 Participants
Subjects Who Experienced Major Bleeding Over Time. 1 year	8 Participants	5 Participants
Subjects Who Experienced Major Bleeding Over Time. 2 year	8 Participants	5 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects Who Experienced Respiratory Failure Over Time 30 days	2 Participants	0 Participants
Subjects Who Experienced Respiratory Failure Over Time 3 months	2 Participants	0 Participants
Subjects Who Experienced Respiratory Failure Over Time 1 year	2 Participants	2 Participants
Subjects Who Experienced Respiratory Failure Over Time 2 year	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time 30 days	2 Participants	2 Participants
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time 3 months	2 Participants	2 Participants
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time 1 year	2 Participants	2 Participants
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time 2 year	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

Number of subjects who experienced Renal (kidney) Failure shown over various time points.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects With Renal Failure Over Time 2 year	3 Participants	1 Participants
Subjects With Renal Failure Over Time 30 days	3 Participants	0 Participants
Subjects With Renal Failure Over Time 3 months	3 Participants	0 Participants
Subjects With Renal Failure Over Time 1 year	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects With Endocarditis Over Time 30 days	0 Participants	0 Participants
Subjects With Endocarditis Over Time 3 months	0 Participants	0 Participants
Subjects With Endocarditis Over Time 1 year	0 Participants	0 Participants
Subjects With Endocarditis Over Time 2 year	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects With a Deep Sternal Would Infection Over Time 30 days	1 Participants	1 Participants
Subjects With a Deep Sternal Would Infection Over Time 3 months	1 Participants	1 Participants
Subjects With a Deep Sternal Would Infection Over Time 1 year	1 Participants	1 Participants
Subjects With a Deep Sternal Would Infection Over Time 2 year	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects With a Myocardial Infarction Over Time 30 days	0 Participants	1 Participants
Subjects With a Myocardial Infarction Over Time 3 months	0 Participants	1 Participants
Subjects With a Myocardial Infarction Over Time 1 year	0 Participants	2 Participants
Subjects With a Myocardial Infarction Over Time 2 year	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects With a Thromboembolism Over Time 30 days	3 Participants	3 Participants
Subjects With a Thromboembolism Over Time 3 months	3 Participants	3 Participants
Subjects With a Thromboembolism Over Time 1 year	4 Participants	4 Participants
Subjects With a Thromboembolism Over Time 2 year	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects With a Cardiac Tamponade Over Time 30 days	2 Participants	3 Participants
Subjects With a Cardiac Tamponade Over Time 3 months	2 Participants	3 Participants
Subjects With a Cardiac Tamponade Over Time 1 year	2 Participants	3 Participants
Subjects With a Cardiac Tamponade Over Time 2 year	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days, 3 Months, 1 Year, 2 Years.

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

Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subjects With a Cardiac Reoperation for Any Reason Over Time 30 days	6 Participants	5 Participants
Subjects With a Cardiac Reoperation for Any Reason Over Time 3 months	6 Participants	5 Participants
Subjects With a Cardiac Reoperation for Any Reason Over Time 1 year	7 Participants	6 Participants
Subjects With a Cardiac Reoperation for Any Reason Over Time 2 year	7 Participants	6 Participants

SECONDARY outcome

Timeframe: Prior to Surgery

Population: Analysis is based on the ITT cohort

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 30 days, 3 Months, 1 Year

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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
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	0.902 units on a scale Standard Deviation 0.087
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time 30 day	0.862 units on a scale Standard Deviation 0.080	0.902 units on a scale Standard Deviation 0.094
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time 3 month	0.908 units on a scale Standard Deviation 0.080	0.918 units on a scale Standard Deviation 0.077
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	0.925 units on a scale Standard Deviation 0.086

SECONDARY outcome

Timeframe: Baseline, 30 days, 3 Months, 1 Year

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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
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	50.26 units on a scale Standard Deviation 11.78
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time PCS - Baseline	42.39 units on a scale Standard Deviation 9.18	40.79 units on a scale Standard Deviation 9.96
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	38.45 units on a scale Standard Deviation 7.86
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	43.95 units on a scale Standard Deviation 7.88
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	44.70 units on a scale Standard Deviation 8.39
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time MCS - Baseline	48.02 units on a scale Standard Deviation 12.85	50.07 units on a scale Standard Deviation 11.80
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	51.37 units on a scale Standard Deviation 9.76
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time MCS - 1 year	51.08 units on a scale Standard Deviation 8.80	52.46 units on a scale Standard Deviation 8.58

SECONDARY outcome

Timeframe: Baseline, 30 days, 3 Months, 1 Year

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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time Baseline	58.37 units on a scale Standard Deviation 24.79	61.33 units on a scale Standard Deviation 24.20
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	64.33 units on a scale Standard Deviation 24.90
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	76.35 units on a scale Standard Deviation 19.91
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	78.11 units on a scale Standard Deviation 21.05

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Health Care Utilization Length of stay	10.9 Days Standard Deviation 7.0	11.5 Days Standard Deviation 9.2
Health Care Utilization ICU Length of stay	2.6 Days Standard Deviation 5.4	1.6 Days Standard Deviation 1.5
Health Care Utilization Intermediate Care Length of stay	1.3 Days Standard Deviation 1.7	0.9 Days Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. Baseline	0.4 centimeters squared/meters squared Standard Deviation 0.1	0.4 centimeters squared/meters squared Standard Deviation 0.1
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. Discharge	0.9 centimeters squared/meters squared Standard Deviation 0.3	1.0 centimeters squared/meters squared Standard Deviation 0.4
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. 30 days	1.0 centimeters squared/meters squared Standard Deviation 0.3	1.1 centimeters squared/meters squared Standard Deviation 0.3
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. 3 months	1.0 centimeters squared/meters squared Standard Deviation 0.2	1.0 centimeters squared/meters squared Standard Deviation 0.3
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. 1 year	1.0 centimeters squared/meters squared Standard Deviation 0.3	0.9 centimeters squared/meters squared Standard Deviation 0.2

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=46 Participants Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.	Control Group - Commercial Surgical Aortic Heart Valve n=48 Participants Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Amount of Aortic Valvular Regurgitation Over Time. 1 year · +2 Mild	5 Participants	1 Participants
Amount of Aortic Valvular Regurgitation Over Time. Discharge · 0 None	29 Participants	29 Participants
Amount of Aortic Valvular Regurgitation Over Time. Discharge · +1 Trivial/Trace	10 Participants	13 Participants
Amount of Aortic Valvular Regurgitation Over Time. Discharge · +2 Mild	1 Participants	2 Participants
Amount of Aortic Valvular Regurgitation Over Time. Discharge · +3 Moderate	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation Over Time. Discharge · +4 Severe	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation Over Time. 30 days · 0 None	25 Participants	29 Participants
Amount of Aortic Valvular Regurgitation Over Time. 30 days · +1 Trivial/Trace	10 Participants	6 Participants
Amount of Aortic Valvular Regurgitation Over Time. 30 days · +2 Mild	0 Participants	3 Participants
Amount of Aortic Valvular Regurgitation Over Time. 30 days · +3 Moderate	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation Over Time. 30 days · +4 Severe	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation Over Time. 3 months · 0 None	27 Participants	25 Participants
Amount of Aortic Valvular Regurgitation Over Time. 3 months · +1 Trivial/Trace	13 Participants	13 Participants
Amount of Aortic Valvular Regurgitation Over Time. 3 months · +2 Mild	2 Participants	2 Participants
Amount of Aortic Valvular Regurgitation Over Time. 3 months · +3 Moderate	1 Participants	0 Participants
Amount of Aortic Valvular Regurgitation Over Time. 3 months · +4 Severe	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation Over Time. 1 year · 0 None	25 Participants	28 Participants
Amount of Aortic Valvular Regurgitation Over Time. 1 year · +1 Trivial/Trace	10 Participants	11 Participants
Amount of Aortic Valvular Regurgitation Over Time. 1 year · +3 Moderate	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation Over Time. 1 year · +4 Severe	0 Participants	0 Participants

Adverse Events

Edwards INTUITY Surgical Aortic Heart Valve

Serious events: 31 serious events

Other events: 27 other events

Deaths: 4 deaths

Control Group - Commercial Surgical Aortic Heart Valve

Serious events: 27 serious events

Other events: 30 other events

Deaths: 4 deaths

Serious adverse events

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 participants at risk Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Control Group - Commercial Surgical Aortic Heart Valve n=48 participants at risk Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Blood and lymphatic system disorders BLEEDING - CARDIOVASCULAR - MAJOR	8.2% 4/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Blood and lymphatic system disorders BLEEDING - GASTROINTESTINAL UPPER -MAJOR	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Blood and lymphatic system disorders BLEEDING - NEUROLOGICAL - MAJOR (E.G. CVA)	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Blood and lymphatic system disorders BLEEDING - PERIPHERAL VASCULAR - MINOR (E.G. NOSEBLEEDS; HEMATOMAS)	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders THROMBOEMBOLIC EVENT - OTHER - CENTRAL - NO PARESIS	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders THROMBOEMBOLIC EVENT - STROKE	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)	8.2% 4/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	8.3% 4/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - AV BLOCK - 3RD DEGREE	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - BRADYCARDIA	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLATION	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT)	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - TACHYCARDIA - VENTRICULAR	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders MYOCARDIAL INFARCTION	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders PERICARDIAL EFFUSION - MAJOR	6.1% 3/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders PERICARDIAL TAMPONADE - MAJOR	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	6.2% 3/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders CARDIAC DECOMPENSATION	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders CARDIAC ARREST	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders CARDIOVASCULAR - OTHER	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders CARDIOGENIC SHOCK	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ENDOCARDITIS	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders PERICARDITIS	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders REGURGITATION - MITRAL-INDETERMINATE-+4	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
General disorders NSD - PARAVALVULAR LEAK - +4	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
General disorders NSD - PARAVALVULAR LEAK WITH HEMOLYSIS	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Gastrointestinal disorders BILIARY (GALLBLADDER)	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Gastrointestinal disorders GASTROINTESTINAL - OTHER	6.1% 3/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Gastrointestinal disorders GASTROINTESTINAL - INFECTION	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Renal and urinary disorders GENITOURINARY - OTHER	6.1% 3/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Renal and urinary disorders RENAL DYSFUNCTION	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Renal and urinary disorders RENAL FAILURE - ACUTE	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Renal and urinary disorders RENAL - OTHER	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Renal and urinary disorders URINARY TRACT INFECTION (UTI)	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Musculoskeletal and connective tissue disorders MUSCULAR SKELETAL / DERMATOLOGIC - OTHER	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	12.5% 6/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Musculoskeletal and connective tissue disorders STERNAL WOUND/THORACIC INFECTION	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Musculoskeletal and connective tissue disorders INFECTION /INFLAMMATION - OTHER	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
General disorders CANCER - NEWLY DIAGNOSED	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
General disorders NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	6.2% 3/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
General disorders ALLERGIC REACTION - MEDICATION RELATED	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
General disorders MULTI-SYSTEM ORGAN FAILURE	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Vascular disorders VASCULAR - OTHER	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Psychiatric disorders TRANSIENT PSYCHOTIC SYNDROME	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION - BILATERAL	10.2% 5/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	6.2% 3/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders RESPIRATORY INFECTION - PNEUMONIA	6.1% 3/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE -PNEUMONIA	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION - LEFT	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE -COPD	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort

Other adverse events

Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 participants at risk Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR	Control Group - Commercial Surgical Aortic Heart Valve n=48 participants at risk Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
Cardiac disorders ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)	8.2% 4/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	12.5% 6/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - PERMANENT ATRIAL FIBRILLATION	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	6.2% 3/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders PERICARDIAL EFFUSION - MINOR	6.1% 3/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	10.4% 5/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Gastrointestinal disorders GASTROINTESTINAL - OTHER	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	6.2% 3/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Musculoskeletal and connective tissue disorders MUSCULAR SKELETAL / DERMATOLOGIC - OTHER	10.2% 5/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	10.4% 5/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION - BILATERAL	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	6.2% 3/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Blood and lymphatic system disorders ANEMIA - NON-BLEEDING RELATED	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Blood and lymphatic system disorders ANEMIA - BLEEDING RELATED - MINOR	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Blood and lymphatic system disorders BLEEDING - GASTROINTESTINAL LOWER -MINOR	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Blood and lymphatic system disorders BLEEDING - PULMONARY/RESPIRATORY MINOR (E.G. HEMOTHORAX)	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Blood and lymphatic system disorders BLOOD/ LYMPHATIC - OTHER	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - ATRIAL FLUTTER	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - AV BLOCK - 1ST DEGREE	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - AV BLOCK - 2ND DEGREE	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - AV BLOCK - 3RD DEGREE	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - BRADYCARDIA	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - PAROXYSMAL ATRIAL TACHYCARDIA (PAT)	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT)	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLATION	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Cardiac disorders CARDIOVASCULAR - OTHER	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
General disorders NSD - PARAVALVULAR LEAK - +1	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Gastrointestinal disorders GASTROINTESTINAL - INFECTION	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Renal and urinary disorders RENAL FAILURE - ACUTE	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Renal and urinary disorders GENITOURINARY - OTHER	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Renal and urinary disorders URINARY TRACT INFECTION (UTI)	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Musculoskeletal and connective tissue disorders WOUND INFECTION - OTHER	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Musculoskeletal and connective tissue disorders INFECTION /INFLAMMATION - OTHER	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
General disorders NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Psychiatric disorders TRANSIENT PSYCHOTIC SYNDROME	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	4.2% 2/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION - LEFT	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION - RIGHT	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders ATELECTASIS	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	4.1% 2/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders PULMONARY/RESPIRATORY - OTHER	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE -COPD	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	0.00% 0/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders RESPIRATORY INFECTION - PNEUMONIA	2.0% 1/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE -OTHER	0.00% 0/49 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort	2.1% 1/48 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using ITT cohort

Additional Information

Mary Edwards, VP Clinical and Regulatory Affairs, HVT

Edwards Lifesciences, LLC

Phone: 949-250-2500

Email: mary_edwards@edwards.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER