Trial Outcomes & Findings for Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (NCT NCT01445171)
NCT ID: NCT01445171
Last Updated: 2023-09-01
Results Overview
Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
295 participants
Primary outcome timeframe
Events occuring within 30 days of procedure
Results posted on
2023-09-01
Participant Flow
Participant milestones
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|
|
Overall Study
STARTED
|
295
|
|
Overall Study
Implanted With Study Device
|
287
|
|
Overall Study
COMPLETED
|
200
|
|
Overall Study
NOT COMPLETED
|
95
|
Reasons for withdrawal
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Withdrawal by Subject
|
16
|
|
Overall Study
Death
|
51
|
|
Overall Study
Subjects declined to return for followup
|
9
|
|
Overall Study
Consented but did not receive device
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|
|
Age, Continuous
|
75.3 years
STANDARD_DEVIATION 6.7 • n=287 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=287 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=287 Participants
|
PRIMARY outcome
Timeframe: Events occuring within 30 days of procedurePopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Percent of Early Adverse Events
Valve Thrombosis
|
0.0 Percentage of subjects
|
—
|
|
Percent of Early Adverse Events
All Cause Mortality
|
1.7 Percentage of subjects
|
—
|
|
Percent of Early Adverse Events
Trial Valve Related Mortality
|
1.0 Percentage of subjects
|
—
|
|
Percent of Early Adverse Events
Thromboembolism
|
4.5 Percentage of subjects
|
—
|
|
Percent of Early Adverse Events
Major Bleeding
|
7.3 Percentage of subjects
|
—
|
|
Percent of Early Adverse Events
All Paravalvular Leak (OPC)
|
1.0 Percentage of subjects
|
—
|
|
Percent of Early Adverse Events
Hemolysis
|
0.7 Percentage of subjects
|
—
|
|
Percent of Early Adverse Events
Endocarditis
|
0.0 Percentage of subjects
|
—
|
|
Percent of Early Adverse Events
Structural Valve Deterioration
|
0.0 Percentage of subjects
|
—
|
|
Percent of Early Adverse Events
Reoperation
|
1.4 Percentage of subjects
|
—
|
|
Percent of Early Adverse Events
Explant
|
1.4 Percentage of subjects
|
—
|
|
Percent of Early Adverse Events
Valve Related AE
|
3.1 Percentage of subjects
|
—
|
PRIMARY outcome
Timeframe: Events occurring >= 31 days and up through 5 years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Number of late adverse 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).
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Percent of Late Adverse Events
Reoperation
|
0.5 Percentage of late adverse events
|
—
|
|
Percent of Late Adverse Events
Explant
|
0.5 Percentage of late adverse events
|
—
|
|
Percent of Late Adverse Events
Valve Related AE
|
1.0 Percentage of late adverse events
|
—
|
|
Percent of Late Adverse Events
All Cause Mortality
|
3.8 Percentage of late adverse events
|
—
|
|
Percent of Late Adverse Events
Trial Valve Related Mortality
|
0.4 Percentage of late adverse events
|
—
|
|
Percent of Late Adverse Events
Thromboembolism
|
1.9 Percentage of late adverse events
|
—
|
|
Percent of Late Adverse Events
Valve Thrombosis
|
0.0 Percentage of late adverse events
|
—
|
|
Percent of Late Adverse Events
Major Bleeding
|
2.1 Percentage of late adverse events
|
—
|
|
Percent of Late Adverse Events
All Paravalvular Leak (OPC)
|
0.6 Percentage of late adverse events
|
—
|
|
Percent of Late Adverse Events
Hemolysis
|
0.2 Percentage of late adverse events
|
—
|
|
Percent of Late Adverse Events
Endocarditis
|
0.3 Percentage of late adverse events
|
—
|
|
Percent of Late Adverse Events
Structural Valve Deterioration
|
0.5 Percentage of late adverse events
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At time of surgery, an average of 3 hoursPopulation: This outcome is reported for enrolled subjects where data is available. Subjects were considered enrolled after meeting all the enrollment criteria, signing the informed consent, and after the surgeon sized the aortic annulus, and determined that the bioprosthesis could be implanted.
Device technical success is defined as the successful delivery and deployment of one bioprosthesis with one delivery system with a maximum of two attempts.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=295 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Number of Subject's With Device Technical Success
|
287 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Discharge(an average of 13 days) or 10 days post-implant, whichever comes firstPopulation: This outcome is reported for enrolled subjects where data is available. Subjects were considered enrolled after meeting all the enrollment criteria, signing the informed consent, and after the surgeon sized the aortic annulus, and determined that the bioprosthesis could be implanted.
Procedure success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker, or subject death.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=295 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Number of Subject's With Procedural Success
|
277 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
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.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=283 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
3 Months · Worsened
|
8 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
1 Year · Improved
|
191 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
1 Year · Same
|
57 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
1 Year · Worsened
|
7 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
2 Years · Improved
|
180 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
2 Years · Same
|
46 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
2 Years · Worsened
|
12 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
3 Years · Improved
|
157 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
3 Years · Same
|
56 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
3 Years · Worsened
|
12 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
4 Years · Improved
|
137 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
4 Years · Same
|
60 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
4 Years · Worsened
|
10 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
5 Years · Improved
|
125 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
5 Years · Same
|
52 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
5 Years · Worsened
|
16 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
1 Month · Improved
|
121 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
1 Month · Same
|
59 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
1 Month · Worsened
|
14 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
3 Months · Improved
|
189 Participants
|
—
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
3 Months · Same
|
65 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 Months, and 1 Year post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=124 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
n=250 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
Baseline
|
0.79 units on a scale
Standard Deviation 0.20
|
0.79 units on a scale
Standard Deviation 0.19
|
|
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
Follow-Up
|
0.87 units on a scale
Standard Deviation 0.18
|
0.83 units on a scale
Standard Deviation 0.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's Average Mean Systolic Gradient Measurements Over Time.
1 Month
|
9.5 mmHg
Standard Deviation 2.8
|
—
|
|
Subject's Average Mean Systolic Gradient Measurements Over Time.
3 Months
|
9.0 mmHg
Standard Deviation 3.4
|
—
|
|
Subject's Average Mean Systolic Gradient Measurements Over Time.
1 Year
|
9.0 mmHg
Standard Deviation 3.5
|
—
|
|
Subject's Average Mean Systolic Gradient Measurements Over Time.
2 Years
|
8.8 mmHg
Standard Deviation 3.0
|
—
|
|
Subject's Average Mean Systolic Gradient Measurements Over Time.
3 Years
|
9.6 mmHg
Standard Deviation 4.3
|
—
|
|
Subject's Average Mean Systolic Gradient Measurements Over Time.
4 Years
|
10.0 mmHg
Standard Deviation 4.7
|
—
|
|
Subject's Average Mean Systolic Gradient Measurements Over Time.
5 Years
|
9.9 mmHg
Standard Deviation 5.1
|
—
|
|
Subject's Average Mean Systolic Gradient Measurements Over Time.
Discharge
|
10.6 mmHg
Standard Deviation 4.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's Average Effective Orifice Area Measurements Over Time.
Discharge
|
1.7 Centimeters Squared
Standard Deviation 0.2
|
—
|
|
Subject's Average Effective Orifice Area Measurements Over Time.
1 Month
|
1.6 Centimeters Squared
Standard Deviation 0.2
|
—
|
|
Subject's Average Effective Orifice Area Measurements Over Time.
3 Months
|
1.7 Centimeters Squared
Standard Deviation 0.2
|
—
|
|
Subject's Average Effective Orifice Area Measurements Over Time.
1 Year
|
1.7 Centimeters Squared
Standard Deviation 0.2
|
—
|
|
Subject's Average Effective Orifice Area Measurements Over Time.
2 Years
|
1.7 Centimeters Squared
Standard Deviation 0.2
|
—
|
|
Subject's Average Effective Orifice Area Measurements Over Time.
3 Years
|
1.7 Centimeters Squared
Standard Deviation 0.2
|
—
|
|
Subject's Average Effective Orifice Area Measurements Over Time.
4 Years
|
1.7 Centimeters Squared
Standard Deviation 0.3
|
—
|
|
Subject's Average Effective Orifice Area Measurements Over Time.
5 Years
|
1.7 Centimeters Squared
Standard Deviation 0.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
1 Month · +3 Moderate
|
0 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
2 Years · +3 Moderate
|
4 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
4 Years · 0 None/+1 Trivial
|
125 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
Discharge · 0 None/+1 Trivial
|
244 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
Discharge · +2 Mild
|
10 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
Discharge · +3 Moderate
|
2 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
Discharge · +4 Severe
|
1 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
1 Month · 0 None/+1 Trivial
|
10 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
1 Month · +2 Mild
|
1 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
1 Month · +4 Severe
|
0 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
3 Months · 0 None/+1 Trivial
|
235 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
3 Months · +2 Mild
|
11 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
3 Months · +3 Moderate
|
4 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
3 Months · +4 Severe
|
1 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
1 Year · 0 None/+1 Trivial
|
231 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
1 Year · +2 Mild
|
14 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
1 Year · +3 Moderate
|
3 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
1 Year · +4 Severe
|
0 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
2 Years · 0 None/+1 Trivial
|
86 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
2 Years · +2 Mild
|
7 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
2 Years · +4 Severe
|
0 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
3 Years · 0 None/+1 Trivial
|
177 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
3 Years · +2 Mild
|
12 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
3 Years · +3 Moderate
|
4 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
3 Years · +4 Severe
|
0 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
4 Years · +2 Mild
|
11 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
4 Years · +3 Moderate
|
4 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
4 Years · +4 Severe
|
0 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
5 Years · 0 None/+1 Trivial
|
161 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
5 Years · +2 Mild
|
9 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
5 Years · +3 Moderate
|
4 Participants
|
—
|
|
Subject's Amount of Aortic Valvular Regurgitation Over Time
5 Years · +4 Severe
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 Months, 1 Year, and 5 Years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's Average White Blood Cell Count Measurement Over Time.
Baseline
|
6.80 10^3 cells/microliters
Standard Deviation 2.0
|
—
|
|
Subject's Average White Blood Cell Count Measurement Over Time.
3 Months
|
6.97 10^3 cells/microliters
Standard Deviation 1.8
|
—
|
|
Subject's Average White Blood Cell Count Measurement Over Time.
1 Year
|
7.10 10^3 cells/microliters
Standard Deviation 2.0
|
—
|
|
Subject's Average White Blood Cell Count Measurement Over Time.
5 Years
|
7.31 10^3 cells/microliters
Standard Deviation 2.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 Months, 1 Year, and 5 Years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's Average Red Blood Cells Count Over Time.
Baseline
|
4.30 10^6 cells/microliters
Standard Deviation 0.5
|
—
|
|
Subject's Average Red Blood Cells Count Over Time.
3 Months
|
4.40 10^6 cells/microliters
Standard Deviation 0.5
|
—
|
|
Subject's Average Red Blood Cells Count Over Time.
1 Year
|
4.36 10^6 cells/microliters
Standard Deviation 0.5
|
—
|
|
Subject's Average Red Blood Cells Count Over Time.
5 Years
|
4.35 10^6 cells/microliters
Standard Deviation 0.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 Months, 1 Year, and 5 Years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's Average Hemoglobin Count Over Time.
1 Year
|
13.00 g/dl
Standard Deviation 1.5
|
—
|
|
Subject's Average Hemoglobin Count Over Time.
5 Years
|
13.16 g/dl
Standard Deviation 1.6
|
—
|
|
Subject's Average Hemoglobin Count Over Time.
Baseline
|
12.87 g/dl
Standard Deviation 1.7
|
—
|
|
Subject's Average Hemoglobin Count Over Time.
3 Months
|
12.49 g/dl
Standard Deviation 1.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 Months, 1 Year, and 5 Years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's Average Hematocrit Percentage Over Time.
Baseline
|
38.29 percentage of red blood cells
Standard Deviation 4.7
|
—
|
|
Subject's Average Hematocrit Percentage Over Time.
3 Months
|
38.07 percentage of red blood cells
Standard Deviation 4.1
|
—
|
|
Subject's Average Hematocrit Percentage Over Time.
1 Year
|
38.93 percentage of red blood cells
Standard Deviation 4.1
|
—
|
|
Subject's Average Hematocrit Percentage Over Time.
5 Years
|
39.58 percentage of red blood cells
Standard Deviation 4.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 Months, 1 Year, and 5 Years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's Average Platelet Count Over Time.
Baseline
|
220.33 10^3 platelets per microliter
Standard Deviation 66.30
|
—
|
|
Subject's Average Platelet Count Over Time.
3 Months
|
223.07 10^3 platelets per microliter
Standard Deviation 59.70
|
—
|
|
Subject's Average Platelet Count Over Time.
1 Year
|
213.22 10^3 platelets per microliter
Standard Deviation 60.40
|
—
|
|
Subject's Average Platelet Count Over Time.
5 Years
|
206.85 10^3 platelets per microliter
Standard Deviation 63.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 Months, 1 Year, and 5 Years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Reticulocytes are immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's Average Reticulocytes Percentage Over Time.
Baseline
|
2.13 percentage of reticulocytes
Standard Deviation 2.5
|
—
|
|
Subject's Average Reticulocytes Percentage Over Time.
3 Months
|
1.59 percentage of reticulocytes
Standard Deviation 1.9
|
—
|
|
Subject's Average Reticulocytes Percentage Over Time.
1 Year
|
2.07 percentage of reticulocytes
Standard Deviation 5.0
|
—
|
|
Subject's Average Reticulocytes Percentage Over Time.
5 Years
|
1.82 percentage of reticulocytes
Standard Deviation 2.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 Months, 1 Year, and 5 Years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Laboratory Analysis of Haptoglobin on blood drawn from subjects; Haptoglobin is a protein produced by the liver.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's Average Haptoglobin Measurement Over Time.
Baseline
|
63.08 g/L
Standard Deviation 69.50
|
—
|
|
Subject's Average Haptoglobin Measurement Over Time.
3 Months
|
82.15 g/L
Standard Deviation 81.10
|
—
|
|
Subject's Average Haptoglobin Measurement Over Time.
1 Year
|
80.65 g/L
Standard Deviation 80.50
|
—
|
|
Subject's Average Haptoglobin Measurement Over Time.
5 Years
|
79.36 g/L
Standard Deviation 81.20
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 Months, 1 Year, and 5 Years post-implantPopulation: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.
Outcome measures
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 Participants
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
Baseline and 1 Year Follow-Up
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|---|
|
Subject's Average Serum LDH Measurement Over Time.
Baseline
|
223.91 U/L
Standard Deviation 53.0
|
—
|
|
Subject's Average Serum LDH Measurement Over Time.
3 Months
|
271.37 U/L
Standard Deviation 87.20
|
—
|
|
Subject's Average Serum LDH Measurement Over Time.
1 Year
|
250.56 U/L
Standard Deviation 76.20
|
—
|
|
Subject's Average Serum LDH Measurement Over Time.
5 Years
|
254.46 U/L
Standard Deviation 76.30
|
—
|
Adverse Events
INTUITY Aortic Valve and INTUITY Delivery System
Serious events: 233 serious events
Other events: 189 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 participants at risk
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|
|
General disorders
Other
|
47.7%
137/287 • Number of events 206 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pleural Effusion
|
19.9%
57/287 • Number of events 60 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Other
|
12.9%
37/287 • Number of events 45 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Other
|
11.1%
32/287 • Number of events 35 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
9.1%
26/287 • Number of events 34 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Atrial Fibrillation
|
11.1%
32/287 • Number of events 32 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
General disorders
Other - Anemia
|
8.7%
25/287 • Number of events 27 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Heart Failure
|
7.0%
20/287 • Number of events 26 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Other Arrhythmia
|
6.3%
18/287 • Number of events 18 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - AV Block III
|
5.9%
17/287 • Number of events 17 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Embolic Event - Stroke
|
5.6%
16/287 • Number of events 17 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Local
|
5.6%
16/287 • Number of events 17 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Pneumonia
|
5.6%
16/287 • Number of events 17 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Renal and urinary disorders
Renal - Renal Failure
|
4.5%
13/287 • Number of events 14 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Vascular disorders
Vascular - Other
|
4.2%
12/287 • Number of events 14 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Gastrointestinal
|
3.5%
10/287 • Number of events 13 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
3.1%
9/287 • Number of events 13 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Post-Procedural
|
4.2%
12/287 • Number of events 12 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Other
|
3.8%
11/287 • Number of events 12 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Hypertension
|
3.8%
11/287 • Number of events 11 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Respiratory Dysfunction/Insufficiency
|
3.1%
9/287 • Number of events 10 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Renal and urinary disorders
Renal - Renal Dysfunction
|
3.1%
9/287 • Number of events 9 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Atrial Flutter
|
2.8%
8/287 • Number of events 8 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Pericardial Effusion
|
2.8%
8/287 • Number of events 8 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Embolic Event - TIA
|
2.4%
7/287 • Number of events 7 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Sternal Wound Infection
|
1.7%
5/287 • Number of events 7 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Cardiac Arrest
|
2.1%
6/287 • Number of events 6 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Myocardial Infarction
|
2.1%
6/287 • Number of events 6 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Sepsis/Septicemia
|
2.1%
6/287 • Number of events 6 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Angina, Stable
|
1.7%
5/287 • Number of events 6 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Respiratory Failure
|
1.4%
4/287 • Number of events 6 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Bacteremia
|
1.7%
5/287 • Number of events 5 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pneumothorax
|
1.7%
5/287 • Number of events 5 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Renal and urinary disorders
Renal - Other
|
1.7%
5/287 • Number of events 5 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Angina, Unstable
|
1.4%
4/287 • Number of events 5 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Anticoagulant Related
|
1.4%
4/287 • Number of events 4 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Hematoma
|
1.4%
4/287 • Number of events 4 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Pericardial Tamponade
|
1.4%
4/287 • Number of events 4 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Bradycardia
|
1.4%
4/287 • Number of events 4 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
General disorders
Other - Allergic Reaction
|
1.4%
4/287 • Number of events 4 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Vascular - Deep Vein Thrombosis (DVT)
|
1.4%
4/287 • Number of events 4 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Endocarditis (Aortic Valve)
|
1.0%
3/287 • Number of events 3 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Hemolysis
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Procedural
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Hypotension
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Supraventricular Tachycardia (SVT)
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Embolic Event - Other
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Embolic Event - Pulmonary Embolism
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Hepatobiliary disorders
Hepatic - Other
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
General disorders
Multisystem Organ Failure
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Paravalvular Leak - Moderate
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Intracranial
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Aortic Dissection - Type A
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Aortic Dissection - Type B
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - AV Block II
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Cardiogenic Shock
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Pericardial Tamponade
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Ventricular Fibrillation
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Embolic Event - Peripheral Embolic Event
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Hepatobiliary disorders
Hepatic - Liver Failure
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Endocarditis (Mitral Valve)
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Systemic
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Atelectasis
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pulmonary Edema
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pulmonary Hypertension
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Aortic Regurgitation - Moderate-Severe
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Mitral Regurgitation - Mild-Moderate
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Mitral Regurgitation - Moderate-Severe
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Other Mitral Valve
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Paravalvular Leak - Mild
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Vascular - Vascular Access Site Complication
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
Other adverse events
| Measure |
INTUITY Aortic Valve and INTUITY Delivery System
n=287 participants at risk
The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
|
|---|---|
|
General disorders
Other
|
29.6%
85/287 • Number of events 128 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Other
|
15.7%
45/287 • Number of events 50 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Atrial Fibrillation
|
15.0%
43/287 • Number of events 43 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
4.2%
12/287 • Number of events 17 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pleural Effusion
|
5.6%
16/287 • Number of events 16 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Local
|
4.5%
13/287 • Number of events 14 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
General disorders
Other - Anemia
|
3.8%
11/287 • Number of events 11 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - BBB - Left Complete
|
3.1%
9/287 • Number of events 9 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Renal and urinary disorders
Renal - Renal Dysfunction
|
3.1%
9/287 • Number of events 9 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Mitral Regurgitation - Mild
|
3.1%
9/287 • Number of events 9 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Other
|
2.8%
8/287 • Number of events 8 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - BBB - Left Partial
|
2.4%
7/287 • Number of events 7 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Other Arrhythmia
|
2.4%
7/287 • Number of events 7 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Pneumonia
|
2.4%
7/287 • Number of events 7 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
2.4%
7/287 • Number of events 7 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Atrial Flutter
|
2.1%
6/287 • Number of events 6 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Sternal Wound Infection
|
2.1%
6/287 • Number of events 6 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Renal and urinary disorders
Renal - Other
|
1.7%
5/287 • Number of events 5 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Aortic Regurgitation - Mild
|
1.7%
5/287 • Number of events 5 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Hematoma
|
1.4%
4/287 • Number of events 4 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Other
|
1.4%
4/287 • Number of events 4 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - BBB - Right Complete
|
1.4%
4/287 • Number of events 4 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Bacteremia
|
1.4%
4/287 • Number of events 4 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Vascular - Deep Vein Thrombosis (DVT)
|
1.4%
4/287 • Number of events 4 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
General disorders
Other - Allergic Reaction
|
1.0%
3/287 • Number of events 4 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Anticoagulant Related
|
1.0%
3/287 • Number of events 3 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - AV Block I
|
1.0%
3/287 • Number of events 3 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Bradycardia
|
1.0%
3/287 • Number of events 3 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Hypertension
|
1.0%
3/287 • Number of events 3 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Ventricular Tachycardia
|
1.0%
3/287 • Number of events 3 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Gastrointestinal disorders
Hepatic - Other
|
1.0%
3/287 • Number of events 3 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Aortic Stenosis - Moderate
|
1.0%
3/287 • Number of events 3 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Gastrointestinal
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - AV Block III
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Pericardial Effusion
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Embolic Event - Other
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Embolic Event - Stroke
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Embolic Event - TIA
|
0.70%
2/287 • Number of events 2 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Hemolysis
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Bleeding - Heparin Induced Thrombocytopenia (HITS)
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Angina, Stable
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Heart Failure
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Hypotension
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Cardiac - Supraventricular Tachycardia (SVT)
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Blood and lymphatic system disorders
Embolic Event - Peripheral Embolic Event
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Infections and infestations
Infection - Systemic
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pneumothorax
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pulmonary Hypertension
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Respiratory Dysfunction/Insufficiency
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Respiratory Failure
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Aortic Regurgitation - Mild-Moderate
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Aortic Stenosis - Mild
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Aortic Stenosis - Severe
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Mitral Regurgitation - Moderate-Severe
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Other Mitral Valve
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Other Tricuspid Valve
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Paravalvular Leak - Mild/Moderate
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Paravalvular Leak - Moderate
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Paravalvular Leak - Trace/Trivial
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Structural Deterioration
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Valvular - Tricuspid Regurgitation
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
|
Cardiac disorders
Vascular - Other
|
0.35%
1/287 • Number of events 1 • Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
|
Additional Information
Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart
Edwards Lifesciences, LLC
Phone: 949-250-2500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 60 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 90 day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.
- Publication restrictions are in place
Restriction type: OTHER