ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluat... | NCT01757665

Label	Type	Description	Intervention Names
Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M	Experimental	Aortic/Mitral valve replacement therapy	Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

Name	Type	Description	Arm Group Labels	Other Names
Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M	Device	Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M	Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M

Measure	Description	Time Frame
Subjects With Structural Valve Deterioration	The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow-up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear.	1 Year Post Implant

Measure	Description	Time Frame
Percentage of Subjects With Early Adverse Events	Number of subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100	Events occuring within 30 days of procedure
Percentage of Late Adverse Events Divided by Late Patient Years

Measure	Description	Time Frame
Subject's Average Mean Gradient Measurements - 11000A	Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.	3 Months, 1 Year, and 2 Year Post Implant

Name	Affiliation	Role
John Puskas, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology, P.C.		Birmingham	Alabama	35211	United States
University of Southern California

PubMed Identifier	Type	Citation	Retractions
28605428	Result	Puskas JD, Bavaria JE, Svensson LG, Blackstone EH, Griffith B, Gammie JS, Heimansohn DA, Sadowski J, Bartus K, Johnston DR, Rozanski J, Rosengart T, Girardi LN, Klodell CT, Mumtaz MA, Takayama H, Halkos M, Starnes V, Boateng P, Timek TA, Ryan W, Omer S, Smith CR; COMMENCE Trial Investigators. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):432-439. doi: 10.1093/ejcts/ezx158.
32340804

Label	URL
New York Heart Association Classification	View source

ID	Title	Description
FG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
FG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 3, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Subjects With Structural Valve Deterioration

The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow-up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear.

The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available. The SVD result combines the aortic and mitral implanted subjects. The study was powered for the combined cohort for this endpoint as there would be too few mitral subjects to report the arms separately.

Posted

Count of Participants

Participants

1 Year Post Implant

ID	Title	Description
OG000	Edwards Pericardial Bioprosthesis, Models 11000A & 11000M	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Units	Counts
Participants	OG000716

Title

Denominators

Categories

Title	Measurements
	OG0001

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	The null hypothesis is that the rate of structural valve deterioration at one year is greater than 1%. The alternative hypothesis is that this rate is less than 1%.					percent of patients	0.1			1-Sided	95		0.7			Upper 95% CI was calculated by the method of Clopper and Pearson, using the Beta distribution with parameters x + 1 and n - x where x is the number of SVD events by POD 390 and n is the number of subjects followed at the 1 year assessment.		Superiority

Secondary

Percentage of Subjects With Early Adverse Events

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

The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.

Posted

Number

percentage of subjects

Events occuring within 30 days of procedure

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Units	Counts
Participants	OG000

Secondary

Percentage of Late Adverse Events Divided by Late Patient Years

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

The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.

Posted

Number

percentage of events/late patient years

Events occurring >= 31 days and up through 3 years post-implant

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Units	Counts
Participants

Other Pre-specified

Subject's Average Mean Gradient Measurements - 11000A

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.

The outcome is reported for subjects who received the Model 11000A device where data is available.

Posted

Mean

Standard Deviation

mmHg

3 Months, 1 Year, and 2 Year Post Implant

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG002	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.

Other Pre-specified

Subject's Average Mean Gradient Measurements - 11000M

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

The outcome is reported for subjects who received the Model 11000M device where data is available.

Posted

Mean

Standard Deviation

mmHg

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG002	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Other Pre-specified

Subject's Average Peak Gradients Measurements Over Time - 11000A

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.

The outcome is reported for subjects who received the Model 11000A device where data is available.

Posted

Mean

Standard Deviation

mmHg

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG002	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.

Other Pre-specified

Subject's Average Peak Gradients Measurements Over Time - 11000M

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

The outcome is reported for subjects who received the Model 11000M device where data is available.

Posted

Mean

Standard Deviation

mmHg

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG002	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Other Pre-specified

Subject's Average Effective Orifice Area Measurements - 11000A

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.

The outcome is reported for subjects who received the Model 11000A device where data is available.

Posted

Mean

Standard Deviation

Centimeters Squared

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG002	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.

Other Pre-specified

Subject's Average Effective Orifice Area Measurements - 11000M

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

The outcome is reported for subjects who received the Model 11000M device where data is available.

Posted

Mean

Standard Deviation

Centimeters Squared

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG002	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Other Pre-specified

Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A

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.

The outcome is reported for subjects who received the Model 11000A device where data is available.

Posted

Mean

Standard Deviation

cm^2/m^2

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG002	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.

Other Pre-specified

Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M

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

The outcome is reported for subjects who received the Model 11000M device where data is available.

Posted

Mean

Standard Deviation

cm^2/m^2

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG002	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Other Pre-specified

Subject's Average Performance Index Measurements - 11000A

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

The outcome is reported for subjects who received the Model 11000A device where data is available.

Posted

Mean

Standard Deviation

cm^2/m^2

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG002	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.

Other Pre-specified

Subject's Average Performance Index Measurements - 11000M

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

The outcome is reported for subjects who received the Model 11000M device where data is available.

Posted

Mean

Standard Deviation

cm^2/m^2

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG002	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Other Pre-specified

Subject's Average Cardiac Output Over Time - 11000A

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

The outcome is reported for subjects who received the Model 11000A device where data is available.

Posted

Mean

Standard Deviation

Liters/minute

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG002	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG003	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm

Other Pre-specified

Subject's Average Cardiac Output Over Time - 11000M

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

The outcome is reported for subjects who received the Model 11000M device where data is available.

Posted

Mean

Standard Deviation

Liters/Minute

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG002	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG003	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm

Other Pre-specified

Subject's Average Cardiac Index Over Time- 11000A

Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual.

The outcome is reported for subjects who received the Model 11000A device where data is available.

Posted

Mean

Standard Deviation

L/min/m^2

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG002	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.

Other Pre-specified

Subject's Average Cardiac Index Over Time - 11000M

Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area(BSA), thus relating heart performance to the size of the individual.

The outcome is reported for subjects who received the Model 11000M device where data is available.

Posted

Mean

Standard Deviation

L/min/m^2

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG002	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Other Pre-specified

Subject's Amount of Total Valvular Regurgitation Over Time - 11000A

Valvular regurgitation occurs when the 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. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

The outcome is reported for subjects who received the Model 11000A device where data is available.

Posted

Count of Participants

Participants

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG002	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.

Other Pre-specified

Subject's Amount of Total Valvular Regurgitation Over Time - 11000M

Mitral valvular regurgitation occurs when the mitral 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. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

The outcome is reported for subjects who received the Model 11000M device where data is available.

Posted

Count of Participants

Participants

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG002	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Other Pre-specified

Subject's Amount of Paravalvular Leak Over Time - 11000A

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.

The outcome is reported for subjects who received the Model 11000A device where data is available.

Posted

Count of Participants

Participants

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG002	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm

Other Pre-specified

Subject's Amount of Paravalvular Leak Over Time - 11000M

Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.

The outcome is reported for subjects who received the Model 11000M device where data is available.

Posted

Count of Participants

Participants

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
OG002	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm

Other Pre-specified

Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline

The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.

Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.

Posted

Count of Participants

Participants

3 Months, 1 Year, and 2 Years Post Implant

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Other Pre-specified

Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey

The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS).

The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.

The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.

The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.

Posted

Mean

Standard Deviation

units on a scale

Baseline and one year post-implant

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Other Pre-specified

Subject's Average White Blood Cell Count

Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection.

The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.

Posted

Mean

Standard Deviation

10^3 cells /microliter

Baseline, Discharge, 3 Months, 1 Year and 2 Year

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Units	Counts
Participants	OG000

Other Pre-specified

Subject's Average Red Blood Cells Count

Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.

The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.

Posted

Mean

Standard Deviation

10^6 cells/microliters

Baseline, Discharge, 3 Months, 1 Year and 2 Year

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Units	Counts
Participants	OG000

Other Pre-specified

Subject's Average Hematocrit Percentage

Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood).

The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Posted

Mean

Standard Deviation

percentage of red blood cells

Baseline, Discharge, 3 Months, 1 Year and 2 Year

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Units	Counts
Participants	OG000

Other Pre-specified

Subject's Average Hemoglobin Count

Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.

The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Posted

Mean

Standard Deviation

g/dl

Baseline, Discharge, 3 Months, 1 Year and 2 Year

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Units	Counts
Participants	OG000

Other Pre-specified

Subject's Average Platelet Count

Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.

The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Posted

Mean

Standard Deviation

10^3 platelets per microliter

Baseline, Discharge, 3 Months, 1 Year, and 2 Years

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Units	Counts
Participants	OG000

Other Pre-specified

Subject's Average Plasma Free Hemoglobin

Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood).

The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Posted

Mean

Standard Deviation

mg/dl

Baseline, Discharge, 3 Months, 1 Year and 2 Year

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Units	Counts
Participants	OG000

Other Pre-specified

Subject's Average International Normalized Ratio

Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects. The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot. INR results will vary according to a person's age, the medicines they take, and any health problems they may have. In general, the higher the INR number, the longer it takes for the blood to clot. In healthy people an INR of 1.1 or below is considered normal. An INR range of 2.0 to 3.0 is generally an effective therapeutic range for people taking blood thinner medication.

The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Posted

Mean

Standard Deviation

Ratio

Baseline, Discharge, 3 Months, 1 Year and 2 Year

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Other Pre-specified

Subject's Average Partial Thromboplastin Time

Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects. PTT is a blood test that looks at how long it takes for the blood to clot.

The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Posted

Mean

Standard Deviation

Seconds

Baseline, Discharge, 3 Months, 1 Year and 2 Year

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Units	Counts
Participants	OG000

Other Pre-specified

Subject's Average Prothrombin Time

Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects. The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot.

The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Posted

Mean

Standard Deviation

Seconds

Baseline, Discharge, 3 Months, 1 Year, and 2 Years

ID	Title	Description
OG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
OG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.

Units	Counts
Participants	OG000

Other Pre-specified

Subjects Average Serum Glycerol Levels

Laboratory analysis of serum glycerol in blood drawn from subjects. This blood test measures the amount of glycerol (a naturally occurring carbohydrate, that can be used as a fuel source by the body) in the serum (liquid portion of the blood).

The outcome is reported for subjects who received the Model 11000A device where data is available.

Posted

Mean

Standard Deviation

micromol/L

Pre-Implant (post-heparinization) and Post-Implant (between 60 and 120 minutes after heart was restarted)

ID	Title	Description
OG000	Edwards Pericardial Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia - Bleeding related - Major	Blood and lymphatic system disorders	Systematic Assessment	EG00012 events12 affected689 at risk EG0012 events2 affected82 at risk
Anemia - Bleeding related - Minor	Blood and lymphatic system disorders	Systematic Assessment	EG00011 events11 affected689 at risk EG0011 events1 affected82 at risk
Anemia - Non-bleeding related	Blood and lymphatic system disorders	Systematic Assessment	EG0006 events6 affected689 at risk EG0013 events3 affected82 at risk
Angina, stable	Cardiac disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0012 events2 affected82 at risk
Angina, unstable	Cardiac disorders	Systematic Assessment	EG0003 events3 affected689 at risk EG0010 events0 affected82 at risk
Arrhythmia - Atrial flutter	Cardiac disorders	Systematic Assessment	EG0007 events7 affected689 at risk EG0013 events3 affected82 at risk
Arrhythmia - AV block - 1st degree	Cardiac disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Arrhythmia - AV block - 2nd degree	Cardiac disorders	Systematic Assessment	EG0004 events4 affected689 at risk EG0010 events0 affected82 at risk
Arrhythmia - AV block - 3rd degree	Cardiac disorders	Systematic Assessment	EG00024 events24 affected689 at risk EG0016 events6 affected82 at risk
Arrhythmia - Bradycardia	Cardiac disorders	Systematic Assessment	EG0004 events4 affected689 at risk EG0011 events1 affected82 at risk
Arrhythmia - Bundle branch block - Left	Cardiac disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Arrhythmia - Bundle branch block - Right	Cardiac disorders	Systematic Assessment	EG0002 events2 affected689 at risk EG0010 events0 affected82 at risk
Arrhythmia - Other	Cardiac disorders	Systematic Assessment	EG00010 events10 affected689 at risk EG0015 events5 affected82 at risk
Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)	Cardiac disorders	Systematic Assessment	EG00041 events39 affected689 at risk EG0019 events8 affected82 at risk
Arrhythmia - Permanent atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0002 events2 affected689 at risk EG0011 events1 affected82 at risk
Arrhythmia - Persistent atrial fibrillation	Cardiac disorders	Systematic Assessment	EG00014 events14 affected689 at risk EG0016 events6 affected82 at risk
Arrhythmia - Supraventricular Tachycardia (SVT)	Cardiac disorders	Systematic Assessment	EG0003 events3 affected689 at risk EG0011 events1 affected82 at risk
Arrhythmia - Tachy-bradycardia	Cardiac disorders	Systematic Assessment	EG0004 events4 affected689 at risk EG0011 events1 affected82 at risk
Arrhythmia - Tachycardia - Ventricular	Cardiac disorders	Systematic Assessment	EG0002 events2 affected689 at risk EG0010 events0 affected82 at risk
Arrhythmia - Ventricular fibrillation	Cardiac disorders	Systematic Assessment	EG0004 events4 affected689 at risk EG0010 events0 affected82 at risk
Biliary (gallbladder)	Gastrointestinal disorders	Systematic Assessment	EG0006 events5 affected689 at risk EG0012 events1 affected82 at risk
Bleeding - Cardiovascular - Major	Blood and lymphatic system disorders	Systematic Assessment	EG00021 events21 affected689 at risk EG0013 events3 affected82 at risk
Bleeding - Cardiovascular - Minor	Blood and lymphatic system disorders	Systematic Assessment	EG0005 events5 affected689 at risk EG0011 events1 affected82 at risk
Bleeding - Gastrointestinal lower - Major	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events3 affected689 at risk EG0010 events0 affected82 at risk
Bleeding - Gastrointestinal lower - Minor	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Bleeding - Gastrointestinal upper - Major	Blood and lymphatic system disorders	Systematic Assessment	EG0005 events4 affected689 at risk EG0012 events2 affected82 at risk
Bleeding - Genitourinary - Minor	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Bleeding - Musculoskeletal/Dermatological - Major (e.g. ecchymosis)	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Bleeding - Neurological - Minor (e.g. CVA)	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected689 at risk EG0014 events4 affected82 at risk
Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas)	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected689 at risk EG0011 events1 affected82 at risk
Bleeding - Pulmonary/Respiratory - Major (e.g. hemothorax)	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected689 at risk EG0010 events0 affected82 at risk
Blood sepsis	Blood and lymphatic system disorders	Systematic Assessment	EG00010 events9 affected689 at risk EG0014 events3 affected82 at risk
Blood/Lymphatic - Other	Blood and lymphatic system disorders	Systematic Assessment	EG0006 events6 affected689 at risk EG0010 events0 affected82 at risk
Bone fracture/Break	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0009 events8 affected689 at risk EG0011 events1 affected82 at risk
Cancer - Newly diagnosed	General disorders	Systematic Assessment	EG0009 events9 affected689 at risk EG0011 events1 affected82 at risk
Cancer - Progression of underlying disease	General disorders	Systematic Assessment	EG0004 events4 affected689 at risk EG0010 events0 affected82 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0006 events6 affected689 at risk EG0013 events3 affected82 at risk
Cardiac decompensation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0011 events1 affected82 at risk
Cardiogenic shock	Cardiac disorders	Systematic Assessment	EG0006 events6 affected689 at risk EG0011 events1 affected82 at risk
Cardiovascular - Other	Cardiac disorders	Systematic Assessment	EG00024 events23 affected689 at risk EG0017 events6 affected82 at risk
Coronary artery ostial obstruction	Cardiac disorders	Systematic Assessment	EG0002 events2 affected689 at risk EG0010 events0 affected82 at risk
Endocarditis	Cardiac disorders	Systematic Assessment	EG0007 events7 affected689 at risk EG0012 events2 affected82 at risk
Endocrine complications	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Fever - Unknown origin	General disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Gastrointestinal - Esophageal rupture/tear	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected689 at risk EG0011 events1 affected82 at risk
Gastrointestinal - Infection	Gastrointestinal disorders	Systematic Assessment	EG0008 events7 affected689 at risk EG0011 events1 affected82 at risk
Gastrointestinal - Other	Gastrointestinal disorders	Systematic Assessment	EG00025 events20 affected689 at risk EG0012 events2 affected82 at risk
Genitourinary - Other	Renal and urinary disorders	Systematic Assessment	EG00010 events9 affected689 at risk EG0011 events1 affected82 at risk
Heart failure - Acute	Cardiac disorders	Systematic Assessment	EG0007 events7 affected689 at risk EG0015 events5 affected82 at risk
Heart Failure - Chronic (CHF)	Cardiac disorders	Systematic Assessment	EG00013 events11 affected689 at risk EG0017 events3 affected82 at risk
Hepatic complication - Other	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected689 at risk EG0010 events0 affected82 at risk
Hypertension - Systemic	Cardiac disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Hypotension	Cardiac disorders	Systematic Assessment	EG0008 events8 affected689 at risk EG0014 events4 affected82 at risk
Hypoxemia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 events5 affected689 at risk EG0010 events0 affected82 at risk
Infection/Inflammation - Other	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0004 events4 affected689 at risk EG0010 events0 affected82 at risk
Metabolic complications	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected689 at risk EG0010 events0 affected82 at risk
Muscular skeletal/Dermatologic - Other	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00031 events27 affected689 at risk EG0015 events5 affected82 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0002 events2 affected689 at risk EG0010 events0 affected82 at risk
Nonspecific, unknown, or other body system - Other complication	General disorders	Systematic Assessment	EG00051 events43 affected689 at risk EG0014 events4 affected82 at risk
NSD - Paravalvular leak +2 Minor	General disorders	Systematic Assessment	EG0000 events0 affected689 at risk EG0011 events1 affected82 at risk
NSD - Paravalvular leak +3 Major	General disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0011 events1 affected82 at risk
NSD - Paravalvular leak +4 Major	General disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Pancreatic complication	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected689 at risk EG0010 events0 affected82 at risk
Pericardial effusion - Major	Cardiac disorders	Systematic Assessment	EG0009 events8 affected689 at risk EG0012 events2 affected82 at risk
Pericardial effusion - Minor	Cardiac disorders	Systematic Assessment	EG0006 events6 affected689 at risk EG0010 events0 affected82 at risk
Pericardial tamponade	Cardiac disorders	Systematic Assessment	EG00010 events10 affected689 at risk EG0011 events1 affected82 at risk
Pericarditis	Cardiac disorders	Systematic Assessment	EG0006 events5 affected689 at risk EG0010 events0 affected82 at risk
Pleural effusion - Bilateral	Cardiac disorders	Systematic Assessment	EG00013 events13 affected689 at risk EG0011 events1 affected82 at risk
Pleural effusion - Left	Cardiac disorders	Systematic Assessment	EG0009 events7 affected689 at risk EG0013 events3 affected82 at risk
Pleural effusion - Right	Cardiac disorders	Systematic Assessment	EG00015 events15 affected689 at risk EG0013 events3 affected82 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00014 events14 affected689 at risk EG0011 events1 affected82 at risk
Psychiatric - Other	Psychiatric disorders	Systematic Assessment	EG0007 events7 affected689 at risk EG0011 events1 affected82 at risk
Psychiatric disorder	Psychiatric disorders	Systematic Assessment	EG0003 events1 affected689 at risk EG0010 events0 affected82 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected689 at risk EG0010 events0 affected82 at risk
Pulmonary embolism - Bilateral	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 events6 affected689 at risk EG0010 events0 affected82 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Pulmonary/Respiratory - Other	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0008 events8 affected689 at risk EG0010 events0 affected82 at risk
Regurgitation - Tricuspid-indeterminate +4	Cardiac disorders	Systematic Assessment	EG0000 events0 affected689 at risk EG0012 events1 affected82 at risk
Renal dysfunction	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected689 at risk EG0012 events2 affected82 at risk
Renal - Other	Renal and urinary disorders	Systematic Assessment	EG0006 events5 affected689 at risk EG0010 events0 affected82 at risk
Renal failure - Acute	Renal and urinary disorders	Systematic Assessment	EG0009 events8 affected689 at risk EG0015 events5 affected82 at risk
Renal failure - Chronic	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Respiratory dysfunction/Insufficiency	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0009 events8 affected689 at risk EG0011 events1 affected82 at risk
Respiratory failure - Acute Respiratory Distress Syndrome (ARDS)	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 events5 affected689 at risk EG0011 events1 affected82 at risk
Respiratory failure - COPD	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 events5 affected689 at risk EG0012 events2 affected82 at risk
Respiratory failure - Hemothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected689 at risk EG0011 events1 affected82 at risk
Respiratory failure - Other	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00012 events10 affected689 at risk EG0014 events4 affected82 at risk
Respiratory failure - Pneumonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 events4 affected689 at risk EG0012 events2 affected82 at risk
Respiratory failure - Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 events4 affected689 at risk EG0010 events0 affected82 at risk
Respiratory infection - Pneumonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0007 events7 affected689 at risk EG0013 events3 affected82 at risk
Respiratory infection - Upper (URI)	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected689 at risk EG0010 events0 affected82 at risk
Speech disorder	General disorders	Systematic Assessment	EG0002 events2 affected689 at risk EG0010 events0 affected82 at risk
Splenic complication	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Sternal wound/Thoracic infection	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00014 events13 affected689 at risk EG0011 events1 affected82 at risk
SVD - Study valve leaflet tear	General disorders	Systematic Assessment	EG0000 events0 affected689 at risk EG0011 events1 affected82 at risk
Thrombocytopenia - Heparin Induced (HIT)	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected689 at risk EG0012 events2 affected82 at risk
Thrombocytopenia - Non-heparin induced	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected689 at risk EG0011 events1 affected82 at risk
Thromboembolic event - Other - Central - No paresis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected689 at risk EG0011 events1 affected82 at risk
Thromboembolic event - Other - Peripheral - No paresis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected689 at risk EG0011 events1 affected82 at risk
Thromboembolic event - Stroke	Cardiac disorders	Systematic Assessment	EG00017 events15 affected689 at risk EG0013 events3 affected82 at risk
Thromboembolic event - Transient Ischemic Attack (TIA)	Cardiac disorders	Systematic Assessment	EG0009 events7 affected689 at risk EG0010 events0 affected82 at risk
Urinary Tract Infection (UTI)	Renal and urinary disorders	Systematic Assessment	EG0004 events4 affected689 at risk EG0011 events1 affected82 at risk
Valve thrombosis - Aortic	Cardiac disorders	Systematic Assessment	EG0000 events0 affected689 at risk EG0011 events1 affected82 at risk
Vascular - Deep Vein Thrombosis (DVT)	Vascular disorders	Systematic Assessment	EG0003 events3 affected689 at risk EG0011 events1 affected82 at risk
Vascular - Other	Vascular disorders	Systematic Assessment	EG0009 events7 affected689 at risk EG0010 events0 affected82 at risk
Vision disorder	General disorders	Systematic Assessment	EG0001 events1 affected689 at risk EG0010 events0 affected82 at risk
Wound infection - Other	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 events5 affected689 at risk EG0010 events0 affected82 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Allergic reaction - Medication related	General disorders	Systematic Assessment	EG0004 events4 affected589 at risk EG0010 events0 affected82 at risk
Allergic reaction - Other	General disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0011 events1 affected82 at risk
Anemia - Bleeding related - Major	Blood and lymphatic system disorders	Systematic Assessment	EG00011 events11 affected589 at risk EG0012 events2 affected82 at risk
Anemia - Bleeding related - Minor	Blood and lymphatic system disorders	Systematic Assessment	EG00087 events87 affected589 at risk EG00118 events18 affected82 at risk
Anemia - Non-bleeding related	Blood and lymphatic system disorders	Systematic Assessment	EG00061 events61 affected589 at risk EG00114 events14 affected82 at risk
Angina, stable	Cardiac disorders	Systematic Assessment	EG0005 events5 affected589 at risk EG0012 events2 affected82 at risk
Angina, unstable	Cardiac disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0010 events0 affected82 at risk
Arrhythmia - Atrial flutter	Cardiac disorders	Systematic Assessment	EG00010 events10 affected589 at risk EG0015 events5 affected82 at risk
Arrhythmia - AV block - 1st degree	Cardiac disorders	Systematic Assessment	EG00040 events39 affected589 at risk EG00111 events11 affected82 at risk
Arrhythmia - AV block - 2nd degree	Cardiac disorders	Systematic Assessment	EG0007 events7 affected589 at risk EG0014 events4 affected82 at risk
Arrhythmia - AV block - 3rd degree	Cardiac disorders	Systematic Assessment	EG0007 events7 affected589 at risk EG0012 events2 affected82 at risk
Arrhythmia - Bradycardia	Cardiac disorders	Systematic Assessment	EG00019 events17 affected589 at risk EG0014 events4 affected82 at risk
Arrhythmia - Bundle branch block - Left	Cardiac disorders	Systematic Assessment	EG00025 events25 affected589 at risk EG0010 events0 affected82 at risk
Arrhythmia - Bundle branch block - Right	Cardiac disorders	Systematic Assessment	EG00030 events28 affected589 at risk EG0013 events3 affected82 at risk
Arrhythmia - Other	Cardiac disorders	Systematic Assessment	EG00050 events50 affected589 at risk EG0018 events8 affected82 at risk
Arrhythmia - Pacemaker/ICD malfunction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0011 events1 affected82 at risk
Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)	Cardiac disorders	Systematic Assessment	EG000137 events136 affected589 at risk EG00112 events12 affected82 at risk
Arrhythmia - Paroxysmal Atrial Tachycardia (PAT)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0010 events0 affected82 at risk
Arrhythmia - Permanent atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0010 events0 affected82 at risk
Arrhythmia - Persistent atrial fibrillation	Cardiac disorders	Systematic Assessment	EG00023 events23 affected589 at risk EG0013 events3 affected82 at risk
Arrhythmia - Supraventricular Tachycardia (SVT)	Cardiac disorders	Systematic Assessment	EG0004 events4 affected589 at risk EG0011 events1 affected82 at risk
Arrhythmia - Tachy-bradycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0011 events1 affected82 at risk
Arrhythmia - Tachycardia - Non-ventricular	Cardiac disorders	Systematic Assessment	EG00021 events20 affected589 at risk EG0011 events1 affected82 at risk
Arrhythmia - Tachycardia - Ventricular	Cardiac disorders	Systematic Assessment	EG00016 events16 affected589 at risk EG0013 events3 affected82 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG000122 events122 affected589 at risk EG00110 events10 affected82 at risk
Biliary (gallbladder)	Gastrointestinal disorders	Systematic Assessment	EG0003 events2 affected589 at risk EG0010 events0 affected82 at risk
Bleeding - Cardiovascular - Major	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected589 at risk EG0010 events0 affected82 at risk
Bleeding - Cardiovascular - Minor	Blood and lymphatic system disorders	Systematic Assessment	EG00010 events10 affected589 at risk EG0010 events0 affected82 at risk
Bleeding - Gastrointestinal lower - Minor	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected589 at risk EG0011 events1 affected82 at risk
Bleeding - Gastrointestinal upper - Minor	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0010 events0 affected82 at risk
Bleeding - Genitourinary - Major	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0012 events2 affected82 at risk
Bleeding - Genitourinary - Minor	Blood and lymphatic system disorders	Systematic Assessment	EG0004 events4 affected589 at risk EG0011 events1 affected82 at risk
Bleeding - Musculoskeletal/Dermatological - Minor (e.g. ecchymosis)	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0011 events1 affected82 at risk
Bleeding - Neurological - Major (e.g. CVA)	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0010 events0 affected82 at risk
Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas)	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected589 at risk EG0012 events2 affected82 at risk
Bleeding - Pulmonary/Respiratory - Minor (e.g. hemothorax)	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0011 events1 affected82 at risk
Blood sepsis	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0011 events1 affected82 at risk
Blood/Lymphatic - Other	Blood and lymphatic system disorders	Systematic Assessment	EG000159 events138 affected589 at risk EG00120 events14 affected82 at risk
Bone fracture/Break	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0006 events5 affected589 at risk EG0011 events1 affected82 at risk
Cancer - Progression of underlying disease	General disorders	Systematic Assessment	EG0003 events3 affected589 at risk EG0010 events0 affected82 at risk
Cardiogenic shock	Cardiac disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0012 events2 affected82 at risk
Cardiovascular - Other	Cardiac disorders	Systematic Assessment	EG00095 events85 affected589 at risk EG00116 events13 affected82 at risk
Endocrine complications	Gastrointestinal disorders	Systematic Assessment	EG0006 events6 affected589 at risk EG0019 events9 affected82 at risk
Fever - Unknown origin	General disorders	Systematic Assessment	EG0004 events4 affected589 at risk EG0012 events2 affected82 at risk
Gastrointestinal - Infection	Gastrointestinal disorders	Systematic Assessment	EG0007 events7 affected589 at risk EG0011 events1 affected82 at risk
Gastrointestinal - Other	Gastrointestinal disorders	Systematic Assessment	EG00031 events29 affected589 at risk EG0019 events9 affected82 at risk
Genitourinary - Other	Renal and urinary disorders	Systematic Assessment	EG00024 events22 affected589 at risk EG0012 events2 affected82 at risk
Hearing disorder	General disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0011 events1 affected82 at risk
Heart failure - Acute	Cardiac disorders	Systematic Assessment	EG00065 events65 affected589 at risk EG0012 events2 affected82 at risk
Heart Failure - Chronic (CHF)	Cardiac disorders	Systematic Assessment	EG00015 events15 affected589 at risk EG0011 events1 affected82 at risk
Hepatic complication - Other	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected589 at risk EG0010 events0 affected82 at risk
Hypertension - Pulmonary	Cardiac disorders	Systematic Assessment	EG0002 events2 affected589 at risk EG0010 events0 affected82 at risk
Hypertension - Systemic	Cardiac disorders	Systematic Assessment	EG00017 events17 affected589 at risk EG0012 events2 affected82 at risk
Hypotension	Cardiac disorders	Systematic Assessment	EG00040 events38 affected589 at risk EG00114 events14 affected82 at risk
Hypoxemia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 events5 affected589 at risk EG0012 events2 affected82 at risk
Infection/Inflammation - Other	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00011 events11 affected589 at risk EG0012 events2 affected82 at risk
Liver Failure - Chronic	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0011 events1 affected82 at risk
Metabolic complications	Gastrointestinal disorders	Systematic Assessment	EG00011 events9 affected589 at risk EG0011 events1 affected82 at risk
Muscular skeletal/Dermatologic - Other	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG000103 events87 affected589 at risk EG00112 events10 affected82 at risk
Nonspecific, unknown, or other body system - Other complication	General disorders	Systematic Assessment	EG000133 events108 affected589 at risk EG00121 events14 affected82 at risk
NSD - Paravalvular leak +1 Minor	General disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0010 events0 affected82 at risk
NSD - Paravalvular leak +2 Minor	General disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0012 events2 affected82 at risk
NSD - Paravalvular leak +3 Major	General disorders	Systematic Assessment	EG0003 events3 affected589 at risk EG0010 events0 affected82 at risk
Pancreatic complication	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0011 events1 affected82 at risk
Perforation - Other	Cardiac disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0010 events0 affected82 at risk
Pericardial effusion - Minor	Cardiac disorders	Systematic Assessment	EG00021 events21 affected589 at risk EG0013 events3 affected82 at risk
Pericarditis	Cardiac disorders	Systematic Assessment	EG0006 events6 affected589 at risk EG0011 events1 affected82 at risk
Pleural effusion - Bilateral	Cardiac disorders	Systematic Assessment	EG00013 events13 affected589 at risk EG0017 events7 affected82 at risk
Pleural effusion - Left	Cardiac disorders	Systematic Assessment	EG00010 events10 affected589 at risk EG0017 events7 affected82 at risk
Pleural effusion - Right	Cardiac disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0013 events3 affected82 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00031 events31 affected589 at risk EG0013 events3 affected82 at risk
Psychiatric - Other	Psychiatric disorders	Systematic Assessment	EG00046 events44 affected589 at risk EG0016 events6 affected82 at risk
Psychiatric disorder	Psychiatric disorders	Systematic Assessment	EG0006 events6 affected589 at risk EG0012 events2 affected82 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00026 events26 affected589 at risk EG0013 events3 affected82 at risk
Pulmonary embolism - Left	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0010 events0 affected82 at risk
Pulmonary embolism - Right	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0011 events1 affected82 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected589 at risk EG0011 events1 affected82 at risk
Pulmonary/Respiratory - Other	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00032 events31 affected589 at risk EG0016 events5 affected82 at risk
Regurgitation - Aortic-central/Transvalvular +3	Cardiac disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0010 events0 affected82 at risk
Regurgitation - Mitral-central/Transvalvular +1	Cardiac disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0012 events2 affected82 at risk
Regurgitation - Mitral-central/Transvalvular +2	Cardiac disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0011 events1 affected82 at risk
Regurgitation - Mitral-central/Transvalvular +3	Cardiac disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0011 events1 affected82 at risk
Regurgitation - Mitral-central/Transvalvular +4	Cardiac disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0010 events0 affected82 at risk
Regurgitation - Mitral-indeterminate +2	Cardiac disorders	Systematic Assessment	EG0002 events2 affected589 at risk EG0010 events0 affected82 at risk
Regurgitation - Mitral-indeterminate +3	Cardiac disorders	Systematic Assessment	EG0003 events3 affected589 at risk EG0010 events0 affected82 at risk
Regurgitation - Tricuspid-indeterminate +3	Cardiac disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0010 events0 affected82 at risk
Regurgitation - Tricuspid-indeterminate +4	Cardiac disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0011 events1 affected82 at risk
Renal - Other	Renal and urinary disorders	Systematic Assessment	EG00018 events18 affected589 at risk EG0011 events1 affected82 at risk
Renal dysfunction	Renal and urinary disorders	Systematic Assessment	EG00011 events10 affected589 at risk EG0011 events1 affected82 at risk
Renal failure - Acute	Renal and urinary disorders	Systematic Assessment	EG00019 events19 affected589 at risk EG0014 events4 affected82 at risk
Renal failure - Chronic	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected589 at risk EG0010 events0 affected82 at risk
Respiratory dysfunction/Insufficiency	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00021 events21 affected589 at risk EG0011 events1 affected82 at risk
Respiratory failure - Acute Respiratory Distress Syndrome (ARDS)	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected589 at risk EG0011 events1 affected82 at risk
Respiratory failure - Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected589 at risk EG0011 events1 affected82 at risk
Respiratory failure - COPD	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected589 at risk EG0010 events0 affected82 at risk
Respiratory failure - Other	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00014 events13 affected589 at risk EG0013 events2 affected82 at risk
Respiratory failure - Pneumonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 events5 affected589 at risk EG0011 events1 affected82 at risk
Respiratory failure - Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 events5 affected589 at risk EG0013 events3 affected82 at risk
Respiratory infection - Pneumonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 events6 affected589 at risk EG0011 events1 affected82 at risk
Respiratory infection - Upper (URI)	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00011 events11 affected589 at risk EG0012 events2 affected82 at risk
Speech disorder	General disorders	Systematic Assessment	EG0001 events1 affected589 at risk EG0011 events1 affected82 at risk
Sternal wound/Thoracic infection	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0009 events9 affected589 at risk EG0010 events0 affected82 at risk
Thrombocytopenia - Heparin Induced (HIT)	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events3 affected589 at risk EG0012 events2 affected82 at risk
Thrombocytopenia - Non-heparin induced	Blood and lymphatic system disorders	Systematic Assessment	EG000134 events134 affected589 at risk EG00118 events18 affected82 at risk
Thromboembolic event - Stroke	Cardiac disorders	Systematic Assessment	EG0002 events2 affected589 at risk EG0010 events0 affected82 at risk
Thromboembolic event - Transient Ischemic Attack (TIA)	Cardiac disorders	Systematic Assessment	EG0006 events6 affected589 at risk EG0010 events0 affected82 at risk
Transient psychotic syndrome	Psychiatric disorders	Systematic Assessment	EG0004 events4 affected589 at risk EG0010 events0 affected82 at risk
Urinary Tract Infection (UTI)	Renal and urinary disorders	Systematic Assessment	EG00026 events26 affected589 at risk EG0019 events6 affected82 at risk
Vascular - Access site complication	Vascular disorders	Systematic Assessment	EG0002 events2 affected589 at risk EG0010 events0 affected82 at risk
Vascular - Deep Vein Thrombosis (DVT)	Vascular disorders	Systematic Assessment	EG0004 events4 affected589 at risk EG0011 events1 affected82 at risk
Vascular - Other	Vascular disorders	Systematic Assessment	EG00019 events19 affected589 at risk EG0011 events1 affected82 at risk
Vision disorder	General disorders	Systematic Assessment	EG00014 events12 affected589 at risk EG0013 events3 affected82 at risk
Wound infection - Other	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0008 events8 affected589 at risk EG0011 events1 affected82 at risk

ID	Term
D001024	Aortic Valve Stenosis
D008946	Mitral Valve Stenosis
D001022	Aortic Valve Insufficiency
D008944	Mitral Valve Insufficiency
D006333	Heart Failure

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014694	Ventricular Outflow Obstruction

ID	Title	Description
BG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
BG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Edwards Pericardial Aortic Bioprosthesis, Model 11000A	The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	26	689	317	689	542	589
EG001	Edwards Pericardial Mitral Bioprosthesis, Model 11000M	The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	8	82	58	82	66	82