Trial Outcomes & Findings for EDWARDS INTUITY Valve System CADENCE Study (NCT NCT02688153)
NCT ID: NCT02688153
Last Updated: 2018-06-01
Results Overview
Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
At time of surgery, an average of 1.5 hours
Results posted on
2018-06-01
Participant Flow
All eligible subjects recruited were randomized to each arm/group as 1:1 ratio at start. Amongst randomized arm/group, three of the subjects randomized to the Edwards INTUITY group were converted to the control group and received commercially available surgical aortic heart valves.
Participant milestones
| Measure |
Edwards INTUITY Surgical Aortic Heart Valve
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
58
|
|
Overall Study
Final Randomized Arm/Group
|
59
|
61
|
|
Overall Study
COMPLETED
|
47
|
51
|
|
Overall Study
NOT COMPLETED
|
15
|
7
|
Reasons for withdrawal
| Measure |
Edwards INTUITY Surgical Aortic Heart Valve
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Overall Study
Death
|
7
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Valve Explant
|
1
|
0
|
|
Overall Study
Conversion to Commercial Valve
|
3
|
0
|
Baseline Characteristics
EDWARDS INTUITY Valve System CADENCE Study
Baseline characteristics by cohort
| Measure |
Edwards INTUITY Surgical Aortic Heart Valve
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.4 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
80.0 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
79.7 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
59 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At time of surgery, an average of 1.5 hoursPopulation: The outcome is reported for subjects where data is available.
Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=58 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Average Subject Time Spent on Cardiopulmonary Cross Clamp
|
77.5 Minutes
Interval 15.0 to 142.0
|
82.0 Minutes
Interval 46.0 to 142.0
|
PRIMARY outcome
Timeframe: At time of surgery, an average of 2 hoursPopulation: The outcome is reported for subjects where data is available.
Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Average Amount of Time Subject Spent on Cardiopulmonary Bypass
|
109.0 Minutes
Interval 53.0 to 179.0
|
107.0 Minutes
Interval 63.0 to 175.0
|
SECONDARY outcome
Timeframe: Baseline and 2 YearsPopulation: The outcome is reported for subjects 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. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=46 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=53 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.
Improved
|
40 Participants
|
43 Participants
|
|
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.
Same
|
6 Participants
|
9 Participants
|
|
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.
Worsend
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: The outcome is reported for subjects 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 |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subject's Average Mean Gradients (mmHg) Measurements Over Time.
30 days
|
10.6 mmHg
Standard Deviation 3.9
|
10.1 mmHg
Standard Deviation 3.6
|
|
Subject's Average Mean Gradients (mmHg) Measurements Over Time.
3 months
|
10.7 mmHg
Standard Deviation 4.0
|
11.1 mmHg
Standard Deviation 3.9
|
|
Subject's Average Mean Gradients (mmHg) Measurements Over Time.
6 months
|
11.7 mmHg
Standard Deviation 4.3
|
11.4 mmHg
Standard Deviation 4.7
|
|
Subject's Average Mean Gradients (mmHg) Measurements Over Time.
1 year
|
11.2 mmHg
Standard Deviation 4.1
|
11.5 mmHg
Standard Deviation 4.4
|
|
Subject's Average Mean Gradients (mmHg) Measurements Over Time.
2 year
|
10.6 mmHg
Standard Deviation 4.4
|
11.3 mmHg
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 30 days, 3 months, 6 months, 1 year, 2 yearPopulation: The outcome is reported for subjects where data is available.
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subject's Average Peak Gradients (mmHg) Measurements Over Time.
30 days
|
19.8 mmHg
Standard Deviation 7.5
|
18.4 mmHg
Standard Deviation 6.1
|
|
Subject's Average Peak Gradients (mmHg) Measurements Over Time.
3 months
|
19.5 mmHg
Standard Deviation 7.0
|
20.2 mmHg
Standard Deviation 7.3
|
|
Subject's Average Peak Gradients (mmHg) Measurements Over Time.
6 months
|
21.1 mmHg
Standard Deviation 7.2
|
20.6 mmHg
Standard Deviation 8.2
|
|
Subject's Average Peak Gradients (mmHg) Measurements Over Time.
1 year
|
20.0 mmHg
Standard Deviation 7.6
|
20.6 mmHg
Standard Deviation 7.7
|
|
Subject's Average Peak Gradients (mmHg) Measurements Over Time.
2 year
|
19.5 mmHg
Standard Deviation 7.8
|
20.4 mmHg
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 30 days, 3 months, 6 months, 1 year, 2 yearPopulation: The outcome is reported for subjects 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 |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subject's Effective Orifice Area (EOA) Measurement Over Time.
30 days
|
1.7 centimeters squared
Standard Deviation 0.5
|
1.6 centimeters squared
Standard Deviation 0.4
|
|
Subject's Effective Orifice Area (EOA) Measurement Over Time.
3 months
|
1.8 centimeters squared
Standard Deviation 0.6
|
1.6 centimeters squared
Standard Deviation 0.3
|
|
Subject's Effective Orifice Area (EOA) Measurement Over Time.
6 months
|
1.7 centimeters squared
Standard Deviation 0.5
|
1.6 centimeters squared
Standard Deviation 0.4
|
|
Subject's Effective Orifice Area (EOA) Measurement Over Time.
1 year
|
1.7 centimeters squared
Standard Deviation 0.4
|
1.5 centimeters squared
Standard Deviation 0.4
|
|
Subject's Effective Orifice Area (EOA) Measurement Over Time.
2 year
|
1.7 centimeters squared
Standard Deviation 0.5
|
1.5 centimeters squared
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 30 days, 3 months, 6 months, 1 year, 2 yearPopulation: The outcome is reported for subjects where data is available.
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.
30 days
|
1.0 centimeters squared/meters squared
Standard Deviation 0.3
|
0.9 centimeters squared/meters squared
Standard Deviation 0.2
|
|
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.
3 months
|
1.0 centimeters squared/meters squared
Standard Deviation 0.3
|
0.9 centimeters squared/meters squared
Standard Deviation 0.2
|
|
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.
6 months
|
0.9 centimeters squared/meters squared
Standard Deviation 0.3
|
0.9 centimeters squared/meters squared
Standard Deviation 0.2
|
|
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.
1 year
|
0.9 centimeters squared/meters squared
Standard Deviation 0.2
|
0.8 centimeters squared/meters squared
Standard Deviation 0.2
|
|
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.
2 year
|
0.9 centimeters squared/meters squared
Standard Deviation 0.3
|
0.8 centimeters squared/meters squared
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 30 days, 3 months, 6 months, 1 year, 2 yearPopulation: The outcome is reported for subjects 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 |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Amount of Aortic Valvular Regurgitation Over Time.
30 days · 0 None
|
30 Participants
|
38 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
30 days · +1 Trivial/Trace
|
12 Participants
|
13 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
30 days · +2 Mild
|
1 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
30 days · +3 Moderate
|
1 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
30 days · +4 Severe
|
0 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
3 months · 0 None
|
30 Participants
|
41 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
3 months · +1 Trivial/Trace
|
11 Participants
|
7 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
3 months · +2 Mild
|
0 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
3 months · +3 Moderate
|
2 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
3 months · +4 Severe
|
0 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
6 months · 0 None
|
27 Participants
|
39 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
6 months · +1 Trivial/Trace
|
9 Participants
|
11 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
6 months · +2 Mild
|
4 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
6 months · +3 Moderate
|
1 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
6 months · +4 Severe
|
0 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
1 year · 0 None
|
30 Participants
|
40 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
1 year · +1 Trivial/Trace
|
8 Participants
|
8 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
1 year · +2 Mild
|
1 Participants
|
1 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
1 year · +3 Moderate
|
1 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
1 year · +4 Severe
|
0 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
2 year · 0 None
|
31 Participants
|
44 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
2 year · +1 Trivial/Trace
|
8 Participants
|
4 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
2 year · +2 Mild
|
0 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
2 year · +3 Moderate
|
1 Participants
|
0 Participants
|
|
Amount of Aortic Valvular Regurgitation Over Time.
2 year · +4 Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Prior to SurgeryPopulation: Original number of subjects randomized to each arm/group.
Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=62 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=58 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery.
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects Who Required a Thoracic Resternotomy Over Time
30 days
|
6 Participants
|
8 Participants
|
|
Subjects Who Required a Thoracic Resternotomy Over Time
3 months
|
6 Participants
|
8 Participants
|
|
Subjects Who Required a Thoracic Resternotomy Over Time
6 months
|
6 Participants
|
8 Participants
|
|
Subjects Who Required a Thoracic Resternotomy Over Time
1 year
|
7 Participants
|
8 Participants
|
|
Subjects Who Required a Thoracic Resternotomy Over Time
2 year
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of Subjects who received a Permanent Pacemaker shown over various time points.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects Who Received a Permanent Pacemaker Over Time.
30 days
|
1 Participants
|
4 Participants
|
|
Subjects Who Received a Permanent Pacemaker Over Time.
3 months
|
1 Participants
|
5 Participants
|
|
Subjects Who Received a Permanent Pacemaker Over Time.
6 months
|
1 Participants
|
6 Participants
|
|
Subjects Who Received a Permanent Pacemaker Over Time.
1 year
|
1 Participants
|
6 Participants
|
|
Subjects Who Received a Permanent Pacemaker Over Time.
2 year
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of subjects who experienced a Major Paravalvular Leak (OPC) shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. A major paravalvular leak (OPC)are any events of leak that required surgical intervention or were considered an serious adverse event.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects With a Major Paravalvular Leak (OPC) Over Time
30 days
|
1 Participants
|
0 Participants
|
|
Subjects With a Major Paravalvular Leak (OPC) Over Time
3 months
|
1 Participants
|
0 Participants
|
|
Subjects With a Major Paravalvular Leak (OPC) Over Time
6 months
|
1 Participants
|
0 Participants
|
|
Subjects With a Major Paravalvular Leak (OPC) Over Time
1 year
|
1 Participants
|
0 Participants
|
|
Subjects With a Major Paravalvular Leak (OPC) Over Time
2 year
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of subjects who experienced Major Bleeding shown over various time points.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects Who Experienced Major Bleeding Over Time.
30 days
|
12 Participants
|
16 Participants
|
|
Subjects Who Experienced Major Bleeding Over Time.
3 months
|
13 Participants
|
17 Participants
|
|
Subjects Who Experienced Major Bleeding Over Time.
6 months
|
15 Participants
|
17 Participants
|
|
Subjects Who Experienced Major Bleeding Over Time.
1 year
|
15 Participants
|
18 Participants
|
|
Subjects Who Experienced Major Bleeding Over Time.
2 year
|
15 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months , 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects Who Experienced Respiratory Failure Over Time
30 days
|
3 Participants
|
1 Participants
|
|
Subjects Who Experienced Respiratory Failure Over Time
3 months
|
3 Participants
|
1 Participants
|
|
Subjects Who Experienced Respiratory Failure Over Time
6 months
|
3 Participants
|
1 Participants
|
|
Subjects Who Experienced Respiratory Failure Over Time
1 year
|
3 Participants
|
1 Participants
|
|
Subjects Who Experienced Respiratory Failure Over Time
2 year
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
30 days
|
0 Participants
|
0 Participants
|
|
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
3 months
|
0 Participants
|
1 Participants
|
|
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
6 months
|
0 Participants
|
2 Participants
|
|
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
1 year
|
1 Participants
|
2 Participants
|
|
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
2 year
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of subjects who experienced Renal (kidney) Failure shown over various time points.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects With Renal Failure Over Time
30 days
|
2 Participants
|
1 Participants
|
|
Subjects With Renal Failure Over Time
3 months
|
2 Participants
|
1 Participants
|
|
Subjects With Renal Failure Over Time
6 months
|
2 Participants
|
1 Participants
|
|
Subjects With Renal Failure Over Time
1 year
|
2 Participants
|
1 Participants
|
|
Subjects With Renal Failure Over Time
2 year
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects With Endocarditis Over Time
30 days
|
0 Participants
|
0 Participants
|
|
Subjects With Endocarditis Over Time
3 months
|
0 Participants
|
0 Participants
|
|
Subjects With Endocarditis Over Time
6 months
|
0 Participants
|
1 Participants
|
|
Subjects With Endocarditis Over Time
1 year
|
1 Participants
|
1 Participants
|
|
Subjects With Endocarditis Over Time
2 year
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects With a Deep Sternal Would Infection Over Time
30 days
|
0 Participants
|
0 Participants
|
|
Subjects With a Deep Sternal Would Infection Over Time
3 months
|
1 Participants
|
0 Participants
|
|
Subjects With a Deep Sternal Would Infection Over Time
6 months
|
1 Participants
|
0 Participants
|
|
Subjects With a Deep Sternal Would Infection Over Time
1 year
|
1 Participants
|
0 Participants
|
|
Subjects With a Deep Sternal Would Infection Over Time
2 year
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects With a Myocardial Infarction Over Time
30 days
|
2 Participants
|
0 Participants
|
|
Subjects With a Myocardial Infarction Over Time
3 months
|
2 Participants
|
1 Participants
|
|
Subjects With a Myocardial Infarction Over Time
6 months
|
3 Participants
|
1 Participants
|
|
Subjects With a Myocardial Infarction Over Time
1 year
|
3 Participants
|
1 Participants
|
|
Subjects With a Myocardial Infarction Over Time
2 year
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects With a Thromboembolism Over Time
30 days
|
2 Participants
|
0 Participants
|
|
Subjects With a Thromboembolism Over Time
3 months
|
2 Participants
|
2 Participants
|
|
Subjects With a Thromboembolism Over Time
6 months
|
3 Participants
|
3 Participants
|
|
Subjects With a Thromboembolism Over Time
1 year
|
4 Participants
|
4 Participants
|
|
Subjects With a Thromboembolism Over Time
2 year
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects With a Cardiac Tamponade Over Time
30 days
|
3 Participants
|
2 Participants
|
|
Subjects With a Cardiac Tamponade Over Time
3 months
|
3 Participants
|
2 Participants
|
|
Subjects With a Cardiac Tamponade Over Time
6 months
|
3 Participants
|
2 Participants
|
|
Subjects With a Cardiac Tamponade Over Time
1 year
|
3 Participants
|
2 Participants
|
|
Subjects With a Cardiac Tamponade Over Time
2 year
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: Cumulative number of subjects with an event by each time point
Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects With a Cardiac Reoperation for Any Reason Over Time
30 days
|
6 Participants
|
9 Participants
|
|
Subjects With a Cardiac Reoperation for Any Reason Over Time
3 months
|
6 Participants
|
11 Participants
|
|
Subjects With a Cardiac Reoperation for Any Reason Over Time
6 months
|
9 Participants
|
12 Participants
|
|
Subjects With a Cardiac Reoperation for Any Reason Over Time
1 year
|
10 Participants
|
12 Participants
|
|
Subjects With a Cardiac Reoperation for Any Reason Over Time
2 year
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: SurgeryPopulation: Number of subjects who died during surgery
Number of subjects who died during surgery.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subjects Who Died Intraoperatively
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: The outcome is reported 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 |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
Baseline
|
0.773 Units on a scale
Standard Deviation 0.155
|
0.723 Units on a scale
Standard Deviation 0.186
|
|
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
30 day
|
0.790 Units on a scale
Standard Deviation 0.180
|
0.771 Units on a scale
Standard Deviation 0.189
|
|
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
3 month
|
0.850 Units on a scale
Standard Deviation 0.179
|
0.808 Units on a scale
Standard Deviation 0.200
|
|
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
6 month
|
0.877 Units on a scale
Standard Deviation 0.136
|
0.827 Units on a scale
Standard Deviation 0.206
|
|
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
1 year
|
0.831 Units on a scale
Standard Deviation 0.172
|
0.803 Units on a scale
Standard Deviation 0.212
|
|
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
2 year
|
0.864 Units on a scale
Standard Deviation 0.160
|
0.835 Units on a scale
Standard Deviation 0.198
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: The outcome is reported where data is available.
The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS). The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status. Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
PCS -Baseline
|
40.67 Units on a scale
Standard Deviation 7.83
|
39.47 Units on a scale
Standard Deviation 7.25
|
|
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
PCS -30 day
|
40.57 Units on a scale
Standard Deviation 7.88
|
41.16 Units on a scale
Standard Deviation 7.02
|
|
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
PCS -3 month
|
44.17 Units on a scale
Standard Deviation 8.77
|
43.73 Units on a scale
Standard Deviation 8.61
|
|
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
PCS -6 month
|
45.87 Units on a scale
Standard Deviation 6.96
|
46.00 Units on a scale
Standard Deviation 8.47
|
|
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
PCS -1 year
|
45.40 Units on a scale
Standard Deviation 8.09
|
46.01 Units on a scale
Standard Deviation 8.52
|
|
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
PCS -2 year
|
44.74 Units on a scale
Standard Deviation 7.92
|
44.02 Units on a scale
Standard Deviation 8.35
|
|
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
MCS -Baseline
|
47.30 Units on a scale
Standard Deviation 10.49
|
44.91 Units on a scale
Standard Deviation 11.16
|
|
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
MCS -30 day
|
48.01 Units on a scale
Standard Deviation 10.63
|
44.85 Units on a scale
Standard Deviation 11.92
|
|
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
MCS -3 month
|
49.56 Units on a scale
Standard Deviation 10.03
|
48.93 Units on a scale
Standard Deviation 9.46
|
|
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
MCS -6 month
|
50.64 Units on a scale
Standard Deviation 9.71
|
48.45 Units on a scale
Standard Deviation 10.10
|
|
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
MCS -1 year
|
51.08 Units on a scale
Standard Deviation 9.38
|
49.52 Units on a scale
Standard Deviation 10.09
|
|
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
MCS -2 year
|
51.65 Units on a scale
Standard Deviation 9.97
|
50.62 Units on a scale
Standard Deviation 9.64
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.Population: The outcome is reported where data is available.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at baseline, 30 days, 3 Months, 6 Months, 1 Year, and 2 Years.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
Baseline
|
64.50 Units on a scale
Standard Deviation 21.95
|
57.50 Units on a scale
Standard Deviation 20.98
|
|
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
30 day
|
71.44 Units on a scale
Standard Deviation 22.69
|
69.24 Units on a scale
Standard Deviation 21.83
|
|
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
3 month
|
83.20 Units on a scale
Standard Deviation 16.26
|
78.26 Units on a scale
Standard Deviation 20.20
|
|
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
6 month
|
85.05 Units on a scale
Standard Deviation 15.71
|
78.74 Units on a scale
Standard Deviation 21.33
|
|
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
1 year
|
82.81 Units on a scale
Standard Deviation 14.86
|
80.26 Units on a scale
Standard Deviation 21.28
|
|
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
2 year
|
83.12 Units on a scale
Standard Deviation 18.62
|
79.31 Units on a scale
Standard Deviation 20.33
|
SECONDARY outcome
Timeframe: Day of surgical procedure through discharge from the hospital, an average of 2 weeksPopulation: This outcome is reported for subjects where data is available.
The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure.
Outcome measures
| Measure |
EDWARDS INTUITY Valve System, Model 8300A
n=59 Participants
Subject who received an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 Participants
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Health Care Utilization
Length of stay
|
12.0 Days
Standard Deviation 7.2
|
10.5 Days
Standard Deviation 5.3
|
|
Health Care Utilization
ICU Length of stay
|
3.9 Days
Standard Deviation 4.2
|
2.9 Days
Standard Deviation 1.9
|
|
Health Care Utilization
Intermediate care length of stay
|
1.2 Days
Standard Deviation 1.9
|
1.2 Days
Standard Deviation 1.4
|
Adverse Events
Edwards INTUITY Surgical Aortic Heart Valve
Serious events: 42 serious events
Other events: 46 other events
Deaths: 7 deaths
Control Group - Commercial Surgical Aortic Heart Valve
Serious events: 38 serious events
Other events: 43 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Edwards INTUITY Surgical Aortic Heart Valve
n=59 participants at risk
Subject who receive an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 participants at risk
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding - cardiovascular - Major
|
8.5%
5/59 • Events occurring from baseline through two years post implant
|
14.8%
9/61 • Events occurring from baseline through two years post implant
|
|
Blood and lymphatic system disorders
Bleeding - Neurological - Major (e.g. CVA)
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
3.3%
2/61 • Events occurring from baseline through two years post implant
|
|
Blood and lymphatic system disorders
ANEMIA - BLEEDING RELATED - MINOR
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Blood and lymphatic system disorders
ANEMIA - NON-BLEEDING RELATED
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Blood and lymphatic system disorders
BLOOD SEPSIS
|
3.4%
2/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Blood and lymphatic system disorders
BLEEDING - MUSCULOSKELETAL/DERMATOLOGICAL -MAJOR (E.G. ECCHYMOSIS)
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Blood and lymphatic system disorders
BLEEDING - PERIPHERAL VASCULAR - MINOR (E.G. NOSEBLEEDS; HEMATOMAS)
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Blood and lymphatic system disorders
BLEEDING - PERIPHERAL VASCULAR -MAJOR (E.G. NOSEBLEEDS; HEMATOMAS)
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Blood and lymphatic system disorders
BLEEDING - GASTROINTESTINAL UPPER -MAJOR
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Blood and lymphatic system disorders
BLEEDING - NEUROLOGICAL - MINOR (E.G. CVA)
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
THROMBOEMBOLIC EVENT - STROKE
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA - HEPARIN INDUCED (HIT)
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
THROMBOEMBOLIC EVENT - OTHER - PERIPHERAL - NO PARESIS
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
|
5.1%
3/59 • Events occurring from baseline through two years post implant
|
6.6%
4/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - AV BLOCK - 1ST DEGREE
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - AV BLOCK - 3RD DEGREE
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
6.6%
4/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - BRADYCARDIA
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLAITON
|
3.4%
2/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - PERMANENT ATRIAL FIBRILLATION
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - TACHYCARDIA - VENTRICULAR
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ANGINA, STABLE
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
3.3%
2/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ANGINA, UNSTABLE
|
3.4%
2/59 • Events occurring from baseline through two years post implant
|
3.3%
2/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
CARDIAC DECOMPENSATION
|
8.5%
5/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
CARDIAC ARREST
|
3.4%
2/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
CARDIOVASCULAR - OTHER
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
HEART FAILURE - ACUTE
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
3.3%
2/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
HEART FAILURE - CHRONIC (CHF)
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
CORONARY ARTERY OSTIAL OBSTRUCTION
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ENDOCARDITIS
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
HYPOTENSION
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
PERICARDIAL EFFUSION - MAJOR
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
HYPERTENSION - SYSTEMIC
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
3.3%
2/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
PERICARDIAL TAMPONADE - MAJOR
|
3.4%
2/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
REGURGITATION - AORTIC-CENTRAL/TRANSVALVULAR-+4
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
General disorders
NSD - PARAVALVULAR LEAK - +2
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Gastrointestinal disorders
GASTROINTESTINAL - INFECTION
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
3.3%
2/61 • Events occurring from baseline through two years post implant
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER
|
5.1%
3/59 • Events occurring from baseline through two years post implant
|
6.6%
4/61 • Events occurring from baseline through two years post implant
|
|
Renal and urinary disorders
RENAL FAILURE - ACUTE
|
5.1%
3/59 • Events occurring from baseline through two years post implant
|
3.3%
2/61 • Events occurring from baseline through two years post implant
|
|
Renal and urinary disorders
RENAL DYSFUNCTION
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Renal and urinary disorders
GENITOURINARY - OTHER
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Renal and urinary disorders
URINARY TRACT INFECTION (UTI)
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR SKELETAL / DERMATOLOGIC - OTHER
|
8.5%
5/59 • Events occurring from baseline through two years post implant
|
4.9%
3/61 • Events occurring from baseline through two years post implant
|
|
Musculoskeletal and connective tissue disorders
BONE FRACTURE/BREAK
|
5.1%
3/59 • Events occurring from baseline through two years post implant
|
3.3%
2/61 • Events occurring from baseline through two years post implant
|
|
Musculoskeletal and connective tissue disorders
STERNAL WOUND/THORACIC INFECTION
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
General disorders
NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION
|
5.1%
3/59 • Events occurring from baseline through two years post implant
|
9.8%
6/61 • Events occurring from baseline through two years post implant
|
|
General disorders
CANCER - NEWLY DIAGNOSED
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
General disorders
ANAPHYLACTIC REACTION
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
General disorders
MULTI-SYSTEM ORGAN FAILURE
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Vascular disorders
VASCULAR - OTHER
|
3.4%
2/59 • Events occurring from baseline through two years post implant
|
3.3%
2/61 • Events occurring from baseline through two years post implant
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION - LEFT
|
8.5%
5/59 • Events occurring from baseline through two years post implant
|
3.3%
2/61 • Events occurring from baseline through two years post implant
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY INFECTION - PNEUMONIA
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
3.3%
2/61 • Events occurring from baseline through two years post implant
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXEMIA
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION - RIGHT
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE -OTHER
|
3.4%
2/59 • Events occurring from baseline through two years post implant
|
1.6%
1/61 • Events occurring from baseline through two years post implant
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE -ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)
|
3.4%
2/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DYSFUNCTION/INSUFFICIENCY
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE -COPD
|
1.7%
1/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
Other adverse events
| Measure |
Edwards INTUITY Surgical Aortic Heart Valve
n=59 participants at risk
Subject who receive an Edwards INTUITY surgical aortic heart valve.
|
Control Group - Commercial Surgical Aortic Heart Valve
n=61 participants at risk
Subject who received a commercially available surgical aortic heart valve.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANEMIA - NON-BLEEDING RELATED
|
16.9%
10/59 • Events occurring from baseline through two years post implant
|
11.5%
7/61 • Events occurring from baseline through two years post implant
|
|
Blood and lymphatic system disorders
ANEMIA - BLEEDING RELATED - MINOR
|
10.2%
6/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Blood and lymphatic system disorders
BLEEDING - CARDIOVASCULAR - MINOR
|
8.5%
5/59 • Events occurring from baseline through two years post implant
|
6.6%
4/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
|
23.7%
14/59 • Events occurring from baseline through two years post implant
|
23.0%
14/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - AV BLOCK - 1ST DEGREE
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
11.5%
7/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT
|
8.5%
5/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT
|
6.8%
4/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLAITON
|
5.1%
3/59 • Events occurring from baseline through two years post implant
|
9.8%
6/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
HYPOTENSION
|
8.5%
5/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
PERICARDIAL EFFUSION - MINOR
|
6.8%
4/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Cardiac disorders
CARDIOVASCULAR - OTHER
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
6.6%
4/61 • Events occurring from baseline through two years post implant
|
|
Renal and urinary disorders
URINARY TRACT INFECTION (UTI)
|
11.9%
7/59 • Events occurring from baseline through two years post implant
|
14.8%
9/61 • Events occurring from baseline through two years post implant
|
|
Renal and urinary disorders
RENAL DYSFUNCTION
|
8.5%
5/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Psychiatric disorders
PSYCHIATRIC DISORDER
|
5.1%
3/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR SKELETAL / DERMATOLOGIC - OTHER
|
0.00%
0/59 • Events occurring from baseline through two years post implant
|
8.2%
5/61 • Events occurring from baseline through two years post implant
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY INFECTION - PNEUMONIA
|
5.1%
3/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY INFECTION - UPPER (URI)
|
5.1%
3/59 • Events occurring from baseline through two years post implant
|
0.00%
0/61 • Events occurring from baseline through two years post implant
|
Additional Information
Mary Edwards, VP Clinical and Regulatory Affairs, HVT
Edwards Lifesciences, LLC
Phone: 949-250-2500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI can't publish/present on overall study results not yet published but may publish his own data subject to EW review prior to submission/presentation, but data analyses of site-specific results can occur only in intervals as specified in the CTA. Publication/presentation of the PI's site-specific results of devices which haven't been market released and which still may be undergoing development, shall not include claims of device safety/effectiveness and will require the review/approval of EW.
- Publication restrictions are in place
Restriction type: OTHER