Trial Outcomes & Findings for Neuroprotection in Patients Undergoing Aortic Valve Replacement (NCT NCT02389894)
NCT ID: NCT02389894
Last Updated: 2019-04-29
Results Overview
freedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting \> 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any present lesions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
383 participants
Primary outcome timeframe
up to 10 days post procedure
Results posted on
2019-04-29
Participant Flow
Participant milestones
| Measure |
Embol-X Embolic Protection Device
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Overall Study
STARTED
|
133
|
118
|
132
|
|
Overall Study
COMPLETED
|
125
|
108
|
123
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
9
|
Reasons for withdrawal
| Measure |
Embol-X Embolic Protection Device
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Overall Study
Death
|
4
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
Baseline Characteristics
Neuroprotection in Patients Undergoing Aortic Valve Replacement
Baseline characteristics by cohort
| Measure |
Embol-X Embolic Protection Device
n=133 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=118 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=132 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
Total
n=383 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
74.6 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
73.6 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
73.9 years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
236 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
358 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
126 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
352 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
99 participants
n=7 Participants
|
113 participants
n=5 Participants
|
326 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 10 days post procedurefreedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting \> 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any present lesions.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=133 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=118 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=132 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction
|
74.4 percentage of participants
Interval 66.4 to 82.5
|
68.0 percentage of participants
Interval 59.1 to 76.8
|
67.6 percentage of participants
Interval 58.8 to 76.4
|
SECONDARY outcome
Timeframe: up to 30 daysPopulation: Three patients withdrew prior to day 30 and are not included in the denominators
The number of patients who have had a clinical ischemic stroke, acute kidney injury (AKI), or death within 30 days of surgery.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=132 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=117 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=131 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury
|
44 Participants
|
25 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: at 7 daysPopulation: Two patients withdrew prior to day 7
The number of patients who experience a clinically apparent stroke by 7 days post-op
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=133 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=117 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=131 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Number of Patients With Clinically Apparent Stroke at 7 Days
|
11 Participants
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysPopulation: Denominator includes all patients with day 7 MRI
The proportion of patients with radiographic infarcts on day 7 (+/-3 days) MRI. Presences of radiographic infarcts were measured using diffusion-weighted 1.5 or 3T MRI scanners
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=115 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=101 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=118 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Presence of Radiographic Infarcts
|
83 Participants
|
66 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: Analysis population includes all those with dwMRI at 7 days
Total infarct volume measured on day 7 dwMRI.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=115 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=101 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=118 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Total Infarct Volume
|
74 mm^3
Interval 0.0 to 322.0
|
42 mm^3
Interval 0.0 to 151.0
|
35 mm^3
Interval 0.0 to 168.0
|
SECONDARY outcome
Timeframe: baseline and 90 daysDecline in neurocognitive function at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=98 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=81 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=96 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Decline in Overall Neurocognition
|
28 Participants
|
24 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: baseline and 90 daysDecline in neurocognitive function in the verbal memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=117 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=94 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=111 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days
|
31 Participants
|
38 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: baseline and 90 daysDecline in neurocognitive function in the visual memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=116 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=95 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=112 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days
|
36 Participants
|
25 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: baseline and 90 daysDecline in neurocognitive function in the executive function domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=103 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=83 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=99 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Decline in Neurocognitive Function in the Executive Function Domain at 90 Day
|
19 Participants
|
25 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: baseline and 90 daysDecline in neurocognitive function in the visuospatial/constructional praxis domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=117 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=98 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=113 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days
|
31 Participants
|
28 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: baseline and 90 daysDecline in neurocognitive function in the Auditory-Verbal Simple attention domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=117 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=96 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=112 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days
|
36 Participants
|
28 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: baseline and 90 daysDecline in neurocognitive function in the Visuomotor/Information Processing Speed domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=110 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=93 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=108 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days
|
43 Participants
|
30 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 90 daysThe scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=127 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=110 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=123 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Modified Rankin Scale >2 at 90 Days
|
5 Participants
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 90 daysAn overall score has full range from 0 to 100, with higher scores indicating greater independence.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=123 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=105 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=120 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Barthel Index <= 80
|
2 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
Embol-X Embolic Protection Device
n=123 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=112 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=122 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days
|
10 Participants
|
7 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: up to 90 daysIncidence of all-cause mortality
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=133 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=118 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=132 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Mortality by 90 Days
|
4 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 90 daysOutcome measures
| Measure |
Embol-X Embolic Protection Device
n=133 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=117 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=131 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Length of Stay for Index Hospitalization
|
10.4 days
Standard Deviation 7.0
|
9.8 days
Standard Deviation 6.7
|
10.3 days
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: up to 90 daysRate of hospital readmissions
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=133 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=117 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=131 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Hospital Readmissions
|
9.3 rate per 100-patient-months
|
8.4 rate per 100-patient-months
|
7.1 rate per 100-patient-months
|
SECONDARY outcome
Timeframe: at 90 daysQuality of Life - Physical Health Composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=122 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=102 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=119 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Quality of Life - Physical Health Composite
|
43.0 T-Score
Standard Deviation 10.8
|
44.9 T-Score
Standard Deviation 8.3
|
44.2 T-Score
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: at 90 daysQuality of life - Mental health composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10.
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=122 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=102 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=119 Participants
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Quality of Life - Mental Health Composite
|
55.2 T-Score
Standard Deviation 10.2
|
55.4 T-Score
Standard Deviation 8.2
|
54.8 T-Score
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: day 1Population: Emboli are not captured by the standard cannula and therefore no data are available for this group in this outcome measure
Assessed by the presence of any debris captured in filter of embolic protection device
Outcome measures
| Measure |
Embol-X Embolic Protection Device
n=116 Participants
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=106 Participants
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Number of Participants With Emboli Captured
|
115 Participants
|
79 Participants
|
0 Participants
|
Adverse Events
Embol-X Embolic Protection Device
Serious events: 72 serious events
Other events: 45 other events
Deaths: 4 deaths
CardioGard Cannula
Serious events: 53 serious events
Other events: 47 other events
Deaths: 5 deaths
Standard Cannula
Serious events: 54 serious events
Other events: 43 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Embol-X Embolic Protection Device
n=133 participants at risk
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=118 participants at risk
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=132 participants at risk
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury - Stage 1
|
2.3%
3/133 • Number of events 3 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Renal and urinary disorders
Acute Kidney Injury - Stage 2
|
3.0%
4/133 • Number of events 4 • 90 Days
|
0.00%
0/118 • 90 Days
|
1.5%
2/132 • Number of events 2 • 90 Days
|
|
Renal and urinary disorders
Acute Kidney Injury - Stage 3
|
5.3%
7/133 • Number of events 7 • 90 Days
|
1.7%
2/118 • Number of events 2 • 90 Days
|
1.5%
2/132 • Number of events 2 • 90 Days
|
|
Blood and lymphatic system disorders
Bleeding - Transfusion > 5 units RBC <24 hours following surgery
|
0.00%
0/133 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
Blood and lymphatic system disorders
Bleeding - Re-operation for hemorrhage or tamponade
|
3.8%
5/133 • Number of events 5 • 90 Days
|
5.9%
7/118 • Number of events 7 • 90 Days
|
3.8%
5/132 • Number of events 5 • 90 Days
|
|
Cardiac disorders
Cardiac Arrhythmias - Cardiac arrest
|
3.8%
5/133 • Number of events 6 • 90 Days
|
0.00%
0/118 • 90 Days
|
1.5%
2/132 • Number of events 2 • 90 Days
|
|
Cardiac disorders
Cardiac Arrhythmias - Sustained ventricular arrhythmia requiring defibrillation or cardioversion
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Cardiac disorders
Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio
|
31.6%
42/133 • Number of events 43 • 90 Days
|
18.6%
22/118 • Number of events 25 • 90 Days
|
18.9%
25/132 • Number of events 25 • 90 Days
|
|
Cardiac disorders
Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring permanent
|
5.3%
7/133 • Number of events 7 • 90 Days
|
5.1%
6/118 • Number of events 6 • 90 Days
|
2.3%
3/132 • Number of events 3 • 90 Days
|
|
Cardiac disorders
Pericardial Fluid Collection
|
3.0%
4/133 • Number of events 4 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
9.0%
12/133 • Number of events 14 • 90 Days
|
8.5%
10/118 • Number of events 13 • 90 Days
|
6.8%
9/132 • Number of events 11 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.3%
3/133 • Number of events 3 • 90 Days
|
2.5%
3/118 • Number of events 3 • 90 Days
|
2.3%
3/132 • Number of events 3 • 90 Days
|
|
Hepatobiliary disorders
Hepatic Dysfunction (Liver injury and Impaired Liver function)
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Infections and infestations
Major Infection - Localized Infection
|
9.8%
13/133 • Number of events 14 • 90 Days
|
5.9%
7/118 • Number of events 7 • 90 Days
|
7.6%
10/132 • Number of events 11 • 90 Days
|
|
Infections and infestations
Major Infection - Endocarditis
|
0.00%
0/133 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Infections and infestations
Major Infection - Sepsis
|
0.75%
1/133 • Number of events 1 • 90 Days
|
1.7%
2/118 • Number of events 2 • 90 Days
|
3.0%
4/132 • Number of events 4 • 90 Days
|
|
Cardiac disorders
Myocardial Infarction - Non-Procedure Related
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Cardiac disorders
Myocardial Infarction - Peri-CABG
|
1.5%
2/133 • Number of events 2 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Nervous system disorders
Neurological Dysfunction- Transient Ischemic Attack - TIA
|
0.00%
0/133 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
Nervous system disorders
Neurological Dysfunction- Ischemic Stroke
|
2.3%
3/133 • Number of events 4 • 90 Days
|
2.5%
3/118 • Number of events 3 • 90 Days
|
3.0%
4/132 • Number of events 4 • 90 Days
|
|
Nervous system disorders
Neurological Dysfunction- Toxic Metabolic Encephalopathy
|
1.5%
2/133 • Number of events 2 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
Nervous system disorders
Neurological Dysfunction- Seizure
|
0.00%
0/133 • 90 Days
|
0.00%
0/118 • 90 Days
|
2.3%
3/132 • Number of events 3 • 90 Days
|
|
Nervous system disorders
Neurological Dysfunction- Other Neurological Dysfunction*
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
2.3%
3/132 • Number of events 3 • 90 Days
|
|
Renal and urinary disorders
Renal Events (Renal Failure)
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
1.5%
2/132 • Number of events 2 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
6.0%
8/133 • Number of events 8 • 90 Days
|
2.5%
3/118 • Number of events 3 • 90 Days
|
7.6%
10/132 • Number of events 11 • 90 Days
|
|
Cardiac disorders
Heart Failure
|
1.5%
2/133 • Number of events 2 • 90 Days
|
3.4%
4/118 • Number of events 4 • 90 Days
|
6.1%
8/132 • Number of events 9 • 90 Days
|
|
Vascular disorders
Venous Thromboembolism Event - Deep Vein Thrombosis
|
1.5%
2/133 • Number of events 3 • 90 Days
|
0.00%
0/118 • 90 Days
|
1.5%
2/132 • Number of events 2 • 90 Days
|
|
Vascular disorders
Venous Thromboembolism Event - Pulmonary Embolism
|
0.00%
0/133 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Vascular disorders
Venous Thromboembolism Event - Other*
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Skin and subcutaneous tissue disorders
Wound Dehiscence
|
2.3%
3/133 • Number of events 3 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/133 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
Blood and lymphatic system disorders
Anemia
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Surgical and medical procedures
Aortic Valve Re-operation
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/133 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/133 • 90 Days
|
0.00%
0/118 • 90 Days
|
1.5%
2/132 • Number of events 2 • 90 Days
|
|
Cardiac disorders
Cardiogenic shock
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/133 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
Gastrointestinal disorders
Cholecystitis
|
0.00%
0/133 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Metabolism and nutrition disorders
Dysphagia with PEG tube placement
|
0.00%
0/133 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
Blood and lymphatic system disorders
Epistaxis
|
0.00%
0/133 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
General disorders
Fever
|
0.00%
0/133 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
General disorders
Fluid Overload
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
General disorders
Foot Pain
|
0.00%
0/133 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
Gastrointestinal disorders
GI Bleed
|
1.5%
2/133 • Number of events 2 • 90 Days
|
0.00%
0/118 • 90 Days
|
1.5%
2/132 • Number of events 2 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.00%
0/133 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/133 • 90 Days
|
0.00%
0/118 • 90 Days
|
1.5%
2/132 • Number of events 2 • 90 Days
|
|
Cardiac disorders
Hypertension
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Gastrointestinal disorders
Intra abdominal bleeding
|
0.00%
0/133 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung mass
|
0.00%
0/133 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Cardiac disorders
Orthostatic Hypertension
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Post-pericardiotomy Syndrome
|
0.00%
0/133 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Surgical and medical procedures
Repair of Aorta
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Cardiac disorders
Severe TR requiring TV replacement
|
0.00%
0/133 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
Gastrointestinal disorders
Small bowel obstruction/ileus
|
1.5%
2/133 • Number of events 2 • 90 Days
|
0.00%
0/118 • 90 Days
|
3.0%
4/132 • Number of events 4 • 90 Days
|
|
Cardiac disorders
Syncope
|
0.75%
1/133 • Number of events 1 • 90 Days
|
1.7%
2/118 • Number of events 2 • 90 Days
|
0.00%
0/132 • 90 Days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.75%
1/133 • Number of events 1 • 90 Days
|
0.00%
0/118 • 90 Days
|
0.76%
1/132 • Number of events 1 • 90 Days
|
|
General disorders
Weakness
|
0.00%
0/133 • 90 Days
|
0.85%
1/118 • Number of events 1 • 90 Days
|
0.00%
0/132 • 90 Days
|
Other adverse events
| Measure |
Embol-X Embolic Protection Device
n=133 participants at risk
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).
|
CardioGard Cannula
n=118 participants at risk
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
|
Standard Cannula
n=132 participants at risk
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
|
|---|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury - Stage 1
|
15.8%
21/133 • Number of events 22 • 90 Days
|
11.0%
13/118 • Number of events 13 • 90 Days
|
15.9%
21/132 • Number of events 21 • 90 Days
|
|
Cardiac disorders
Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio
|
17.3%
23/133 • Number of events 24 • 90 Days
|
28.8%
34/118 • Number of events 34 • 90 Days
|
18.2%
24/132 • Number of events 24 • 90 Days
|
|
Infections and infestations
Major Infection - Localized Infection
|
6.0%
8/133 • Number of events 9 • 90 Days
|
5.1%
6/118 • Number of events 7 • 90 Days
|
5.3%
7/132 • Number of events 7 • 90 Days
|
Additional Information
Annetine C. Gelijns, PhD
Icahn School of Medicine at Mount Sinai
Phone: 212-659-9568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place