Trial Outcomes & Findings for EDWARDS INTUITY Elite Valve System (NCT NCT02907463)

Last Updated: 2019-11-22

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

Target enrollment

280 participants

Primary outcome timeframe

At time of surgery; an average of 1 hour

Results posted on

2019-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	EDWARDS INTUITY Elite Valve System The system includes the EDWARDS INTUITY Elite Aortic Valve, Model 8300AB and the EDWARDS INTUITY Elite Delivery System, Model 8300DB.
Overall Study STARTED	280
Overall Study Enrolled Cohort	280
Overall Study Per Protocol Cohort	276
Overall Study COMPLETED	243
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Reasons for withdrawal
Measure	EDWARDS INTUITY Elite Valve System The system includes the EDWARDS INTUITY Elite Aortic Valve, Model 8300AB and the EDWARDS INTUITY Elite Delivery System, Model 8300DB.
Overall Study Lost to Follow-up	17
Overall Study Death	10
Overall Study Withdrawal by Subject	4
Overall Study MIS Approach was not used	2
Overall Study Not Implanted with Study Device	2
Overall Study Device Explanted	1
Overall Study Missing Exit Form	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Per Protocol Cohort n=276 Participants The per protocol cohort will consist of all enrolled patients that leave the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Age, Continuous	73.7 years STANDARD_DEVIATION 6.8 • n=276 Participants
Sex: Female, Male Female	142 Participants n=276 Participants
Sex: Female, Male Male	134 Participants n=276 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 per protocol cohort.

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average Time Spent on Cardiopulmonary Cross Clamp Partial Sternotomy	49.9 minutes Standard Deviation 14.7	—	—	—	—	—
Subject's Average Time Spent on Cardiopulmonary Cross Clamp Right Thoracotomy	65.2 minutes Standard Deviation 18.2	—	—	—	—	—
Subject's Average Time Spent on Cardiopulmonary Cross Clamp All	51.9 minutes Standard Deviation 16.0	—	—	—	—	—

SECONDARY outcome

Timeframe: At time of surgery; an average of 1.5 hours

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

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

Outcome measures
Measure	Per Protocol Cohort n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average Time Spent on Cardiopulmonary Bypass.	79.0 minutes Standard Deviation 23.4	—	—	—	—	—

SECONDARY outcome

Timeframe: At time of surgery

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

The successful delivery and deployment of the EDWARDS INTUITY Elite valve and delivery system, and the subject leaving the operating room with valve in place.

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=280 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Device Technical Success Rate	276 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: At time of surgery

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

The successful delivery and deployment of the valve and delivery system during the first attempt, and subject leaving the operating room with EDWARDS INTUITY Elite valve in place.

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=280 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
First Attempt Success Rate	270 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day of procedure and events occurring within 10 days of procedure

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

Procedural success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker (with baseline sinus rhythm and no other conduction issues), or subject death, within discharge or 10 days post index procedure whichever comes first.

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=280 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Procedural Success	274 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day of surgical procedure through discharge from the hospital, an average of 3 days and 10 days respectively.

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

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

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=278 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average Health Care Utilization Hospital Length of Stay	9.5 days Standard Deviation 6.7	—	—	—	—	—
Subject's Average Health Care Utilization ICU Length of Stay	3.3 days Standard Deviation 7.2	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Discharge and 6 months

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

Outcome measures
Measure	Per Protocol Cohort n=29 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm n=89 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm n=75 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm n=63 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm n=20 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average Mean Gradient Measurements Over Time. Baseline	50 mmHg Standard Deviation 18.1	46.6 mmHg Standard Deviation 13.7	44.5 mmHg Standard Deviation 13.0	45.3 mmHg Standard Deviation 13.4	45.1 mmHg Standard Deviation 16.5	46.0 mmHg Standard Deviation 14.1
Subject's Average Mean Gradient Measurements Over Time. Discharge	15.0 mmHg Standard Deviation 5.6	12.8 mmHg Standard Deviation 5.0	9.7 mmHg Standard Deviation 3.4	9.8 mmHg Standard Deviation 3.6	7.6 mmHg Standard Deviation 3.0	11.1 mmHg Standard Deviation 4.7
Subject's Average Mean Gradient Measurements Over Time. 6 months	11.7 mmHg Standard Deviation 4.4	9.7 mmHg Standard Deviation 3.4	8.0 mmHg Standard Deviation 3.7	7.8 mmHg Standard Deviation 2.6	6.1 mmHg Standard Deviation 2.9	8.8 mmHg Standard Deviation 3.7

SECONDARY outcome

Timeframe: Baseline, Discharge and 6 months

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

Outcome measures
Measure	Per Protocol Cohort n=29 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm n=89 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm n=75 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm n=63 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm n=20 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average Peak Gradients Measurements Over Time. Baseline	80.3 mmHg Standard Deviation 25.9	78.9 mmHg Standard Deviation 22.8	73.4 mmHg Standard Deviation 20.8	74.8 mmHg Standard Deviation 20.9	74.0 mmHg Standard Deviation 22.0	76.3 mmHg Standard Deviation 22.1
Subject's Average Peak Gradients Measurements Over Time. Discharge	28.0 mmHg Standard Deviation 10.4	25.0 mmHg Standard Deviation 10.7	18.4 mmHg Standard Deviation 6.6	18.6 mmHg Standard Deviation 7.3	15.3 mmHg Standard Deviation 6.2	21.4 mmHg Standard Deviation 9.5
Subject's Average Peak Gradients Measurements Over Time. 6 months	23.6 mmHg Standard Deviation 8.4	19.7 mmHg Standard Deviation 7.6	15.7 mmHg Standard Deviation 6.7	15.0 mmHg Standard Deviation 4.7	12.6 mmHg Standard Deviation 4.9	17.5 mmHg Standard Deviation 7.4

SECONDARY outcome

Timeframe: Baseline, Discharge and 6 months

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

Outcome measures
Measure	Per Protocol Cohort n=29 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm n=89 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm n=75 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm n=63 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm n=20 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average Effective Orifice Area (EOA) Measurements Over Time Baseline	0.7 centimeters squared Standard Deviation 0.2	0.8 centimeters squared Standard Deviation 0.3	0.8 centimeters squared Standard Deviation 0.2	0.9 centimeters squared Standard Deviation 0.2	1.0 centimeters squared Standard Deviation 0.2	0.8 centimeters squared Standard Deviation 0.3
Subject's Average Effective Orifice Area (EOA) Measurements Over Time Discharge	1.2 centimeters squared Standard Deviation 0.3	1.5 centimeters squared Standard Deviation 0.6	1.9 centimeters squared Standard Deviation 0.6	2.0 centimeters squared Standard Deviation 0.6	2.3 centimeters squared Standard Deviation 0.7	1.8 centimeters squared Standard Deviation 0.6
Subject's Average Effective Orifice Area (EOA) Measurements Over Time 6 months	1.2 centimeters squared Standard Deviation 0.3	1.5 centimeters squared Standard Deviation 0.4	1.9 centimeters squared Standard Deviation 0.5	2.1 centimeters squared Standard Deviation 0.5	2.5 centimeters squared Standard Deviation 0.6	1.8 centimeters squared Standard Deviation 0.6

SECONDARY outcome

Timeframe: Discharge and 6 months

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

Outcome measures
Measure	Per Protocol Cohort n=29 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm n=89 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm n=75 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm n=63 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm n=20 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. Discharge	0.7 centimeters squared/meters squared Standard Deviation 0.2	0.9 centimeters squared/meters squared Standard Deviation 0.4	1.0 centimeters squared/meters squared Standard Deviation 0.3	1.0 centimeters squared/meters squared Standard Deviation 0.3	1.1 centimeters squared/meters squared Standard Deviation 0.4	0.9 centimeters squared/meters squared Standard Deviation 0.3
Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. 6 months	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.8 centimeters squared/meters squared Standard Deviation 0.2	1.0 centimeters squared/meters squared Standard Deviation 0.3	1.1 centimeters squared/meters squared Standard Deviation 0.3	1.2 centimeters squared/meters squared Standard Deviation 0.3	0.9 centimeters squared/meters squared Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline, Discharge and 6 months

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

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

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=29 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm n=89 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm n=75 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm n=63 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm n=20 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average Performance Index Measurements Over Time. Baseline	0.5 cm2/cm2 Standard Deviation 0.1	0.5 cm2/cm2 Standard Deviation 0.2	0.4 cm2/cm2 Standard Deviation 0.1	0.4 cm2/cm2 Standard Deviation 0.1	0.4 cm2/cm2 Standard Deviation 0.1	0.5 cm2/cm2 Standard Deviation 0.2
Subject's Average Performance Index Measurements Over Time. Discharge	0.9 cm2/cm2 Standard Deviation 0.2	1.0 cm2/cm2 Standard Deviation 0.4	1.0 cm2/cm2 Standard Deviation 0.3	1.0 cm2/cm2 Standard Deviation 0.3	0.9 cm2/cm2 Standard Deviation 0.3	1.0 cm2/cm2 Standard Deviation 0.3
Subject's Average Performance Index Measurements Over Time. 6 months	1.0 cm2/cm2 Standard Deviation 0.2	1.0 cm2/cm2 Standard Deviation 0.2	1.0 cm2/cm2 Standard Deviation 0.3	1.0 cm2/cm2 Standard Deviation 0.2	1.0 cm2/cm2 Standard Deviation 0.2	1.0 cm2/cm2 Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline, Discharge and 6 months

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

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

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=29 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm n=89 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm n=75 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm n=63 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm n=20 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average Cardiac Output Over Time Baseline	4.8 liters per minute Standard Deviation 1.2	5.3 liters per minute Standard Deviation 1.5	5.4 liters per minute Standard Deviation 1.3	6.1 liters per minute Standard Deviation 1.8	6.2 liters per minute Standard Deviation 1.5	5.5 liters per minute Standard Deviation 1.5
Subject's Average Cardiac Output Over Time Discharge	4.0 liters per minute Standard Deviation 1.1	4.9 liters per minute Standard Deviation 1.7	5.4 liters per minute Standard Deviation 1.5	5.7 liters per minute Standard Deviation 1.6	5.0 liters per minute Standard Deviation 1.4	5.1 liters per minute Standard Deviation 1.6
Subject's Average Cardiac Output Over Time 6 months	4.1 liters per minute Standard Deviation 0.9	4.5 liters per minute Standard Deviation 1.0	4.8 liters per minute Standard Deviation 1.4	5.2 liters per minute Standard Deviation 1.0	5.4 liters per minute Standard Deviation 1.6	4.8 liters per minute Standard Deviation 1.2

SECONDARY outcome

Timeframe: Discharge and 6 months

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

A measure of cardiac output per square meter of body surface area

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=29 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm n=89 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm n=75 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm n=63 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm n=20 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average Cardiac Index Discharge	2.3 L/min/meters squared Standard Deviation 0.6	2.7 L/min/meters squared Standard Deviation 0.8	2.8 L/min/meters squared Standard Deviation 0.8	2.8 L/min/meters squared Standard Deviation 0.8	2.4 L/min/meters squared Standard Deviation 0.7	2.7 L/min/meters squared Standard Deviation 0.8
Subject's Average Cardiac Index 6 months	2.4 L/min/meters squared Standard Deviation 0.3	2.5 L/min/meters squared Standard Deviation 0.6	2.6 L/min/meters squared Standard Deviation 0.9	2.6 L/min/meters squared Standard Deviation 0.5	2.6 L/min/meters squared Standard Deviation 0.6	2.6 L/min/meters squared Standard Deviation 0.7

SECONDARY outcome

Timeframe: Discharge and 6 months

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

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

Outcome measures
Measure	Per Protocol Cohort n=29 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm n=89 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm n=75 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm n=63 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm n=20 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Amount of Paravalvular Leak Over Time. Discharge · 0 None	19 Participants	59 Participants	45 Participants	45 Participants	14 Participants	182 Participants
Subject's Amount of Paravalvular Leak Over Time. Discharge · +1 Trivial/Trace	1 Participants	6 Participants	5 Participants	5 Participants	0 Participants	17 Participants
Subject's Amount of Paravalvular Leak Over Time. Discharge · +2 Mild	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants	4 Participants
Subject's Amount of Paravalvular Leak Over Time. Discharge · +3 Moderate	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Subject's Amount of Paravalvular Leak Over Time. Discharge · +4 Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time. 6 months · 0 None	18 Participants	55 Participants	49 Participants	40 Participants	15 Participants	177 Participants
Subject's Amount of Paravalvular Leak Over Time. 6 months · +1 Trivial/Trace	1 Participants	6 Participants	4 Participants	4 Participants	0 Participants	15 Participants
Subject's Amount of Paravalvular Leak Over Time. 6 months · +2 Mild	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Subject's Amount of Paravalvular Leak Over Time. 6 months · +3 Moderate	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Subject's Amount of Paravalvular Leak Over Time. 6 months · +4 Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Discharge and 6 Months

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

Outcome measures
Measure	Per Protocol Cohort n=29 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm n=89 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm n=75 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm n=63 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm n=20 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Amount of Aortic Valvular Regurgitation Over Time. Discharge · 0 None	15 Participants	61 Participants	48 Participants	40 Participants	14 Participants	178 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. Discharge · +1 Trivial/Trace	5 Participants	7 Participants	3 Participants	11 Participants	1 Participants	27 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. Discharge · +2 Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. Discharge · +3 Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. Discharge · +4 Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 6 months · 0 None	14 Participants	54 Participants	46 Participants	40 Participants	13 Participants	167 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 6 months · +1 Trivial/Trace	6 Participants	8 Participants	8 Participants	5 Participants	3 Participants	30 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 6 months · +2 Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 6 months · +3 Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 6 months · +4 Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

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

The Medical Outcomes Study Short-Form 36 - Physical Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average SF-36 Physical Health Summary Baseline	42.6 units on a scale Standard Deviation 8.1	—	—	—	—	—
Subject's Average SF-36 Physical Health Summary 6 months	47.6 units on a scale Standard Deviation 8.1	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

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

The Medical Outcomes Study Short-Form 36 - Mental Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average SF-36 Mental Health Summary Baseline	45.5 units on a scale Standard Deviation 10.4	—	—	—	—	—
Subject's Average SF-36 Mental Health Summary 6 months	50.1 units on a scale Standard Deviation 10.1	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months compared to baseline

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

Outcome measures
Measure	Per Protocol Cohort n=239 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline All Subjects · Class I	169 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline All Subjects · Class II	63 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline All Subjects · Class III	7 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline All Subjects · Class IV	0 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class I · Class I	9 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class I · Class II	0 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class I · Class III	0 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class I · Class IV	0 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class II · Class I	85 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class II · Class II	25 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class II · Class III	1 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class II · Class IV	0 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class III · Class I	71 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class III · Class II	38 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class III · Class III	6 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class III · Class IV	0 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class IV · Class I	4 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class IV · Class II	0 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class IV · Class III	0 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline Preoperative Classification, Class IV · Class IV	0 Participants	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

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

Outcome measures
Measure	Per Protocol Cohort n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time Baseline	0.73 units on a scale Standard Deviation 0.21	—	—	—	—	—
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time 6 months	0.82 units on a scale Standard Deviation 0.22	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day of surgical procedure through discharge from the hospital; an average of 7 days

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

Considered as the day at which the patient was fit for hospital discharge.

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=275 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Subject's Average Fitness for Hospital Discharge	6.8 days Standard Deviation 6.1	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Events occurring within 30 days of procedure

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

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

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) All Cause Mortality	1.1 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Trial Valve Related Mortality	0.0 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Thromboembolism	3.6 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Stroke	2.9 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) TIA	0.0 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Non-cerebral Embolism	0.7 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Valve Thrombosis	0.0 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Major Bleeding	0.4 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Minor Paravalvular Leak (OPC)	0.4 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Major Paravalvular Leak (OPC)	0.4 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Hemolysis	0.0 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) NSVD Other than PVL	0.0 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Endocarditis	0.0 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Structural Valve Deterioration	0.0 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Reoperation	0.0 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Explant	0.0 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Renal Failure	2.2 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Respiratory Failure/Dysfunction	1.1 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Deep Sternal Wound Infection	0.7 Percentage of events/subjects	—	—	—	—	—
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) Permanent Pacemaker Implant	6.7 Percentage of events/subjects	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Events occuring >= 31 days and up through 6 months

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

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

Outcome measures

Outcome measures
Measure	Per Protocol Cohort n=276 Participants The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 21mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 23mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 25mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - 27mm The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	Per Protocol Cohort - Total The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) All Cause Mortality	6.1 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Trial Valve Related Mortality	3.5 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Thromboembolism	1.7 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Stroke	1.7 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) TIA	0.0 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Non-cerebral Embolism	0.0 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Valve Thrombosis	0.0 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Major Bleeding	2.6 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Minor Paravalvular Leak (OPC)	0.0 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Major Paravalvular Leak (OPC)	0.9 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Hemolysis	0.0 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) NSVD Other than PVL	0.9 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Endocarditis	0.0 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Structural Valve Deterioration	0.9 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Reoperation	1.7 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Explant	1.7 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Renal Failure	0.0 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Respiratory Failure/Dysfunction	0.9 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Deep Sternal Wound Infection	1.7 percentage of events/late patient years	—	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) Permanent Pacemaker Implant	1.8 percentage of events/late patient years	—	—	—	—	—

Adverse Events

Per Protocol Cohort

Serious events: 108 serious events

Other events: 155 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Per Protocol Cohort n=280 participants at risk The per protocol cohort will consist of all enrolled patients that leave the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Blood and lymphatic system disorders Anemia - Bleeding related - Minor	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - AV Block - 1st degree	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - AV Block - 2nd degree	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - AV Block - 3rd degree	3.9% 11/280 • Number of events 11 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Atrial Flutter	1.4% 4/280 • Number of events 4 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Bradycardia	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Bundle Branch Block - Left	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Other	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)	5.7% 16/280 • Number of events 17 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Permanent Atrial Fibrillation	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Persistent Atrial Fibrillation	2.5% 7/280 • Number of events 8 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Supraventricular Tachycardia (SVT)	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Tachy-Bradycardia	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Ventricular Fibrillation	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Gastrointestinal disorders Biliary (Gallbladder)	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Bleeding - Cardiovascular - Major	2.5% 7/280 • Number of events 7 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Bleeding - Gastrointestinal Lower - Minor	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Bleeding - Gastrointestinal Upper - Major	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Bleeding - Gastrointestinal Upper - Minor	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Bleeding - Neurological - Major	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Musculoskeletal and connective tissue disorders Bone Fracture / Break	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
General disorders Cancer - Newly diagnosed	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
General disorders Cancer - Progression of underlying disease	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Cardiac Arrest	1.1% 3/280 • Number of events 3 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Chordae tendineae damage	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Infections and infestations Deep Sternal Wound / Thoracic Infection	1.4% 4/280 • Number of events 4 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
General disorders Fever - Unknown Origin	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Gastrointestinal disorders Gastrointestinal - Infection	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Gastrointestinal disorders Gastrointestinal - Other	1.1% 3/280 • Number of events 3 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Ear and labyrinth disorders Hearing disorder	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Heart Failure - Acute	2.5% 7/280 • Number of events 8 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Heart Failure - Chronic (CHF)	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Infections and infestations Infection / Inflammation - Other	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
General disorders Multi-System organ failure	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Musculoskeletal and connective tissue disorders Muscular Skeletal / Dermatologic - Other	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Myocardial Infarction	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders NSVD - LVOT damage	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders NSVD - Paravalvular Leak - +2	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
General disorders Nonspecific, Unknown, or Other Body System - Other complication	1.1% 3/280 • Number of events 3 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Gastrointestinal disorders Pancreatic complication	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Perforation - Atrial	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Pericardial Effusion - Major	2.1% 6/280 • Number of events 6 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Pericardial Effusion - Minor	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Pericardial Tamponade	3.6% 10/280 • Number of events 10 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Pleural Effusion - Bilateral	1.4% 4/280 • Number of events 4 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Pleural Effusion - Left	1.1% 3/280 • Number of events 4 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Pleural Effusion - Right	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Infection - Lower (Bronchitis)	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Psychiatric disorders Psychiatric - Other	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Psychiatric disorders Psychiatric Disorder	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism - Right	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Renal and urinary disorders Renal Dysfunction	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Renal and urinary disorders Renal Failure - Acute	1.4% 4/280 • Number of events 4 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Renal and urinary disorders Renal - Other	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Failure - COPD	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Failure - Other	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Failure - Pneumonia	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Infection - Pneumonia	1.4% 4/280 • Number of events 4 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Insufficiency	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Splenic complication	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
General disorders Sudden, Unexplained Death	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Infections and infestations Superficial Wound Infection - Sternal	1.1% 3/280 • Number of events 3 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Thromboembolic Event - Other - Central - Hemiparesis	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Thromboembolic Event - Stroke	2.9% 8/280 • Number of events 8 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Psychiatric disorders Transient Psychotic Syndrome	1.1% 3/280 • Number of events 3 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Renal and urinary disorders Urinary Tract Infection (UTI)	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Vascular disorders Vascular - Access Site Complication	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Vascular disorders Vascular - Other	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.

Other adverse events

Other adverse events
Measure	Per Protocol Cohort n=280 participants at risk The per protocol cohort will consist of all enrolled patients that leave the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Blood and lymphatic system disorders Anemia - Bleeding related - Minor	2.5% 7/280 • Number of events 8 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Anemia - Non-bleeding related	4.6% 13/280 • Number of events 13 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Angina, Stable	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - AV Block - 1st degree	2.9% 8/280 • Number of events 8 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - AV Block - 2nd degree	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - AV Block - 3rd degree	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Atrial Flutter	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Bradycardia	1.4% 4/280 • Number of events 4 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Bundle Branch Block - Left	18.9% 53/280 • Number of events 53 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Bundle Branch Block - Right	1.1% 3/280 • Number of events 3 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)	20.4% 57/280 • Number of events 59 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Paroxysmal Atrial Tachycardia (PAT)	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Persistent Atrial Fibrillation	4.6% 13/280 • Number of events 13 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Tachy-Bradycardia	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Tachycardia - Non-Ventricular	1.4% 4/280 • Number of events 5 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Tachycardia - Ventricular	1.1% 3/280 • Number of events 3 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Arrhythmia - Ventricular Fibrillation	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Bleeding - Cardiovascular - Major	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Bleeding - Genitourinary - Major	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Bleeding - Genitourinary - Minor	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Bleeding - Musculoskeletal/Dermatological - Minor	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Bleeding - Pulmonary/Respiratory Minor	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Blood/ Lymphatic - Other	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Musculoskeletal and connective tissue disorders Bone Fracture / Break	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Cardiogenic Shock	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Cardiovascular - Other	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Endocrine disorders Endocrine complications	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
General disorders Fever - Unknown Origin	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Infections and infestations Gastrointestinal - Infection	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Gastrointestinal disorders Gastrointestinal - Other	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Hepatobiliary disorders Hepatic complication - Other	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Hypertension - Pulmonary	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Hypertension - Systemic	1.8% 5/280 • Number of events 5 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Hypotension	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Infections and infestations Infection / Inflammation - Other	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Metabolism and nutrition disorders Metabolic complications	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Musculoskeletal and connective tissue disorders Muscular Skeletal / Dermatologic - Other	1.1% 3/280 • Number of events 3 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders NSVD - Paravalvular Leak - +1	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders NSVD - Paravalvular Leak - +2	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
General disorders Nonspecific, Unknown, or Other Body System - Other complication	1.8% 5/280 • Number of events 5 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Pericardial Effusion - Minor	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Pleural Effusion - Bilateral	1.1% 3/280 • Number of events 3 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Pleural Effusion - Left	1.4% 4/280 • Number of events 4 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Pleural Effusion - Right	3.2% 9/280 • Number of events 9 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.1% 3/280 • Number of events 3 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Psychiatric disorders Psychiatric - Other	1.4% 4/280 • Number of events 4 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Psychiatric disorders Psychiatric Disorder	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Respiratory, thoracic and mediastinal disorders Pulmonary/Respiratory - Other	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Cardiac disorders Regurgitation - Aortic-Central/Transvalvular-+1	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Renal and urinary disorders Renal Dysfunction	2.5% 7/280 • Number of events 7 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Renal and urinary disorders Renal Failure - Acute	2.1% 6/280 • Number of events 6 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Infections and infestations Respiratory Infection - Lower (Bronchitis)	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Infections and infestations Respiratory Infection - Pneumonia	1.1% 3/280 • Number of events 3 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Insufficiency	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Infections and infestations Superficial Wound Infection - Sternal	1.1% 3/280 • Number of events 3 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Blood and lymphatic system disorders Thrombocytopenia - Heparin Induced (HIT)	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Psychiatric disorders Transient Psychotic Syndrome	3.9% 11/280 • Number of events 11 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Renal and urinary disorders Urinary Tract Infection (UTI)	2.1% 6/280 • Number of events 6 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Vascular disorders Vascular - Access Site Complication	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Vascular disorders Vascular - Other	0.36% 1/280 • Number of events 1 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Infections and infestations Wound Infection - Other	0.71% 2/280 • Number of events 2 • Events occurring from baseline through 6 months post implant This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.

Additional Information

Mary Edwards, VP Clinical and Regulatory Affairs, Surgical Structural Heart

Edwards Lifesciences, LLC

Phone: 949-250-2500

Email: [email protected]

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