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Neuroprotection in Patients Undergoing Aortic Valve Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02389894
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Annetine Gelijns, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Aortic Stenosis
Brain Infarction
Cerebrovascular Accident
Stroke
Interventions Device: Embol-X Embolic Protection Device
Device: CardioGard Cannula
Enrollment 383
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Period Title: Overall Study
Started 133 118 132
Completed 125 108 123
Not Completed 8 10 9
Reason Not Completed
Death             4             5             3
Withdrawal by Subject             2             4             5
Lost to Follow-up             2             1             1
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula Total
Hide Arm/Group Description

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing. Total of all reporting groups
Overall Number of Baseline Participants 133 118 132 383
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 118 participants 132 participants 383 participants
73.6  (6.6) 74.6  (6.8) 73.6  (6.7) 73.9  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 118 participants 132 participants 383 participants
Female
52
  39.1%
49
  41.5%
46
  34.8%
147
  38.4%
Male
81
  60.9%
69
  58.5%
86
  65.2%
236
  61.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 118 participants 132 participants 383 participants
Hispanic or Latino
4
   3.0%
5
   4.2%
8
   6.1%
17
   4.4%
Not Hispanic or Latino
127
  95.5%
110
  93.2%
121
  91.7%
358
  93.5%
Unknown or Not Reported
2
   1.5%
3
   2.5%
3
   2.3%
8
   2.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 118 participants 132 participants 383 participants
American Indian or Alaska Native
1
   0.8%
1
   0.8%
0
   0.0%
2
   0.5%
Asian
0
   0.0%
0
   0.0%
5
   3.8%
5
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   4.5%
7
   5.9%
6
   4.5%
19
   5.0%
White
126
  94.7%
108
  91.5%
118
  89.4%
352
  91.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
   1.7%
3
   2.3%
5
   1.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 133 participants 118 participants 132 participants 383 participants
Canada 19 19 19 57
United States 114 99 113 326
1.Primary Outcome
Title Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction
Hide Description 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.
Time Frame up to 10 days post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 133 118 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74.4
(66.4 to 82.5)
68.0
(59.1 to 76.8)
67.6
(58.8 to 76.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Embol-X Embolic Protection Device, Standard Cannula
Comments A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Chi-squared
Comments The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 6.9
Confidence Interval (2-Sided) 95%
-4.2 to 17.9
Estimation Comments The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Embol-x minus control
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CardioGard Cannula, Standard Cannula
Comments A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-11.2 to 13.8
Estimation Comments The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Cardiogard minus control.
2.Secondary Outcome
Title Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury
Hide Description The number of patients who have had a clinical ischemic stroke, acute kidney injury (AKI), or death within 30 days of surgery.
Time Frame up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients withdrew prior to day 30 and are not included in the denominators
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 132 117 131
Measure Type: Count of Participants
Unit of Measure: Participants
44
  33.3%
25
  21.4%
31
  23.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Embol-X Embolic Protection Device, CardioGard Cannula
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 9.7
Confidence Interval (2-Sided) 95%
-1.2 to 20.5
Estimation Comments The absolute difference was computed as Embol-x minus control
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CardioGard Cannula, Standard Cannula
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-13.5 to 7.9
Estimation Comments The absolute difference was computed as Cardiogard minus control
3.Secondary Outcome
Title Number of Patients With Clinically Apparent Stroke at 7 Days
Hide Description The number of patients who experience a clinically apparent stroke by 7 days post-op
Time Frame at 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients withdrew prior to day 7
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 133 117 131
Measure Type: Count of Participants
Unit of Measure: Participants
11
   8.3%
6
   5.1%
8
   6.1%
4.Secondary Outcome
Title Presence of Radiographic Infarcts
Hide Description 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
Time Frame up to 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Denominator includes all patients with day 7 MRI
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 115 101 118
Measure Type: Count of Participants
Unit of Measure: Participants
83
  72.2%
66
  65.3%
76
  64.4%
5.Secondary Outcome
Title Total Infarct Volume
Hide Description Total infarct volume measured on day 7 dwMRI.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes all those with dwMRI at 7 days
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 115 101 118
Median (Inter-Quartile Range)
Unit of Measure: mm^3
74
(0 to 322)
42
(0 to 151)
35
(0 to 168)
6.Secondary Outcome
Title Decline in Overall Neurocognition
Hide Description Decline 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.
Time Frame baseline and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 98 81 96
Measure Type: Count of Participants
Unit of Measure: Participants
28
  28.6%
24
  29.6%
31
  32.3%
7.Secondary Outcome
Title Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days
Hide Description Decline 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.
Time Frame baseline and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 117 94 111
Measure Type: Count of Participants
Unit of Measure: Participants
31
  26.5%
38
  40.4%
35
  31.5%
8.Secondary Outcome
Title Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days
Hide Description Decline 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.
Time Frame baseline and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 116 95 112
Measure Type: Count of Participants
Unit of Measure: Participants
36
  31.0%
25
  26.3%
32
  28.6%
9.Secondary Outcome
Title Decline in Neurocognitive Function in the Executive Function Domain at 90 Day
Hide Description Decline 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.
Time Frame baseline and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 103 83 99
Measure Type: Count of Participants
Unit of Measure: Participants
19
  18.4%
25
  30.1%
31
  31.3%
10.Secondary Outcome
Title Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days
Hide Description Decline 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.
Time Frame baseline and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 117 98 113
Measure Type: Count of Participants
Unit of Measure: Participants
31
  26.5%
28
  28.6%
41
  36.3%
11.Secondary Outcome
Title Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days
Hide Description Decline 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.
Time Frame baseline and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 117 96 112
Measure Type: Count of Participants
Unit of Measure: Participants
36
  30.8%
28
  29.2%
38
  33.9%
12.Secondary Outcome
Title Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days
Hide Description Decline 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.
Time Frame baseline and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 110 93 108
Measure Type: Count of Participants
Unit of Measure: Participants
43
  39.1%
30
  32.3%
33
  30.6%
13.Secondary Outcome
Title Modified Rankin Scale >2 at 90 Days
Hide Description

The 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.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 127 110 123
Measure Type: Count of Participants
Unit of Measure: Participants
5
   3.9%
7
   6.4%
5
   4.1%
14.Secondary Outcome
Title Barthel Index <= 80
Hide Description An overall score has full range from 0 to 100, with higher scores indicating greater independence.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 123 105 120
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.6%
2
   1.9%
4
   3.3%
15.Secondary Outcome
Title Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days
Hide Description [Not Specified]
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 123 112 122
Measure Type: Count of Participants
Unit of Measure: Participants
10
   8.1%
7
   6.3%
19
  15.6%
16.Secondary Outcome
Title Mortality by 90 Days
Hide Description Incidence of all-cause mortality
Time Frame up to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 133 118 132
Measure Type: Count of Participants
Unit of Measure: Participants
4
   3.0%
5
   4.2%
3
   2.3%
17.Secondary Outcome
Title Length of Stay for Index Hospitalization
Hide Description [Not Specified]
Time Frame up to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 133 117 131
Mean (Standard Deviation)
Unit of Measure: days
10.4  (7.0) 9.8  (6.7) 10.3  (6.2)
18.Secondary Outcome
Title Hospital Readmissions
Hide Description Rate of hospital readmissions
Time Frame up to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 133 117 131
Measure Type: Number
Unit of Measure: rate per 100-patient-months
9.3 8.4 7.1
19.Secondary Outcome
Title Quality of Life - Physical Health Composite
Hide Description Quality 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.
Time Frame at 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 122 102 119
Mean (Standard Deviation)
Unit of Measure: T-Score
43.0  (10.8) 44.9  (8.3) 44.2  (9.0)
20.Secondary Outcome
Title Quality of Life - Mental Health Composite
Hide Description Quality 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.
Time Frame at 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 122 102 119
Mean (Standard Deviation)
Unit of Measure: T-Score
55.2  (10.2) 55.4  (8.2) 54.8  (8.0)
21.Secondary Outcome
Title Number of Participants With Emboli Captured
Hide Description Assessed by the presence of any debris captured in filter of embolic protection device
Time Frame day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Emboli are not captured by the standard cannula and therefore no data are available for this group in this outcome measure
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description:

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Overall Number of Participants Analyzed 116 106 0
Measure Type: Count of Participants
Unit of Measure: Participants
115
  99.1%
79
  74.5%
0
Time Frame 90 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Hide Arm/Group Description

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).

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).

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
All-Cause Mortality
Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/133 (3.01%)      5/118 (4.24%)      3/132 (2.27%)    
Hide Serious Adverse Events
Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   72/133 (54.14%)      53/118 (44.92%)      54/132 (40.91%)    
Blood and lymphatic system disorders       
Bleeding - Transfusion > 5 units RBC <24 hours following surgery   0/133 (0.00%)  0 1/118 (0.85%)  1 1/132 (0.76%)  1
Bleeding - Re-operation for hemorrhage or tamponade   5/133 (3.76%)  5 7/118 (5.93%)  7 5/132 (3.79%)  5
Anemia   1/133 (0.75%)  1 0/118 (0.00%)  0 0/132 (0.00%)  0
Disseminated Intravascular Coagulation   1/133 (0.75%)  1 0/118 (0.00%)  0 0/132 (0.00%)  0
Epistaxis   0/133 (0.00%)  0 1/118 (0.85%)  1 1/132 (0.76%)  1
Thrombocytopenia   1/133 (0.75%)  1 0/118 (0.00%)  0 1/132 (0.76%)  1
Cardiac disorders       
Cardiac Arrhythmias - Cardiac arrest   5/133 (3.76%)  6 0/118 (0.00%)  0 2/132 (1.52%)  2
Cardiac Arrhythmias - Sustained ventricular arrhythmia requiring defibrillation or cardioversion   1/133 (0.75%)  1 0/118 (0.00%)  0 0/132 (0.00%)  0
Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio   42/133 (31.58%)  43 22/118 (18.64%)  25 25/132 (18.94%)  25
Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring permanent   7/133 (5.26%)  7 6/118 (5.08%)  6 3/132 (2.27%)  3
Pericardial Fluid Collection   4/133 (3.01%)  4 1/118 (0.85%)  1 0/132 (0.00%)  0
Myocardial Infarction - Non-Procedure Related   1/133 (0.75%)  1 0/118 (0.00%)  0 0/132 (0.00%)  0
Myocardial Infarction - Peri-CABG   2/133 (1.50%)  2 0/118 (0.00%)  0 0/132 (0.00%)  0
Heart Failure   2/133 (1.50%)  2 4/118 (3.39%)  4 8/132 (6.06%)  9
Bradycardia   0/133 (0.00%)  0 0/118 (0.00%)  0 2/132 (1.52%)  2
Cardiogenic shock   1/133 (0.75%)  1 0/118 (0.00%)  0 1/132 (0.76%)  1
Chest Pain   0/133 (0.00%)  0 0/118 (0.00%)  0 1/132 (0.76%)  1
Hypertension   1/133 (0.75%)  1 0/118 (0.00%)  0 0/132 (0.00%)  0
Orthostatic Hypertension   1/133 (0.75%)  1 0/118 (0.00%)  0 0/132 (0.00%)  0
Severe TR requiring TV replacement   0/133 (0.00%)  0 0/118 (0.00%)  0 1/132 (0.76%)  1
Syncope   1/133 (0.75%)  1 2/118 (1.69%)  2 0/132 (0.00%)  0
Endocrine disorders       
Adrenal Insufficiency   0/133 (0.00%)  0 0/118 (0.00%)  0 1/132 (0.76%)  1
Gastrointestinal disorders       
Appendicitis   0/133 (0.00%)  0 1/118 (0.85%)  1 0/132 (0.00%)  0
Cholecystitis   0/133 (0.00%)  0 1/118 (0.85%)  1 0/132 (0.00%)  0
GI Bleed   2/133 (1.50%)  2 0/118 (0.00%)  0 2/132 (1.52%)  2
Intra abdominal bleeding   0/133 (0.00%)  0 0/118 (0.00%)  0 1/132 (0.76%)  1
Pneumoperitoneum   1/133 (0.75%)  1 0/118 (0.00%)  0 0/132 (0.00%)  0
Small bowel obstruction/ileus   2/133 (1.50%)  2 0/118 (0.00%)  0 4/132 (3.03%)  4
General disorders       
Fever   0/133 (0.00%)  0 0/118 (0.00%)  0 1/132 (0.76%)  1
Fluid Overload   1/133 (0.75%)  1 0/118 (0.00%)  0 0/132 (0.00%)  0
Foot Pain   0/133 (0.00%)  0 0/118 (0.00%)  0 1/132 (0.76%)  1
Weakness   0/133 (0.00%)  0 1/118 (0.85%)  1 0/132 (0.00%)  0
Hepatobiliary disorders       
Hepatic Dysfunction (Liver injury and Impaired Liver function)   1/133 (0.75%)  1 1/118 (0.85%)  1 0/132 (0.00%)  0
Infections and infestations       
Major Infection - Localized Infection   13/133 (9.77%)  14 7/118 (5.93%)  7 10/132 (7.58%)  11
Major Infection - Endocarditis   0/133 (0.00%)  0 1/118 (0.85%)  1 0/132 (0.00%)  0
Major Infection - Sepsis   1/133 (0.75%)  1 2/118 (1.69%)  2 4/132 (3.03%)  4
Metabolism and nutrition disorders       
Dysphagia with PEG tube placement   0/133 (0.00%)  0 0/118 (0.00%)  0 1/132 (0.76%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung mass   0/133 (0.00%)  0 1/118 (0.85%)  1 0/132 (0.00%)  0
Nervous system disorders       
Neurological Dysfunction- Transient Ischemic Attack - TIA   0/133 (0.00%)  0 0/118 (0.00%)  0 1/132 (0.76%)  1
Neurological Dysfunction- Ischemic Stroke   3/133 (2.26%)  4 3/118 (2.54%)  3 4/132 (3.03%)  4
Neurological Dysfunction- Toxic Metabolic Encephalopathy   2/133 (1.50%)  2 1/118 (0.85%)  1 1/132 (0.76%)  1
Neurological Dysfunction- Seizure   0/133 (0.00%)  0 0/118 (0.00%)  0 3/132 (2.27%)  3
Neurological Dysfunction- Other Neurological Dysfunction*   1/133 (0.75%)  1 0/118 (0.00%)  0 3/132 (2.27%)  3
Renal and urinary disorders       
Acute Kidney Injury - Stage 1   3/133 (2.26%)  3 1/118 (0.85%)  1 0/132 (0.00%)  0
Acute Kidney Injury - Stage 2   4/133 (3.01%)  4 0/118 (0.00%)  0 2/132 (1.52%)  2
Acute Kidney Injury - Stage 3   7/133 (5.26%)  7 2/118 (1.69%)  2 2/132 (1.52%)  2
Renal Events (Renal Failure)   1/133 (0.75%)  1 0/118 (0.00%)  0 2/132 (1.52%)  2
Respiratory, thoracic and mediastinal disorders       
Pleural Effusion   12/133 (9.02%)  14 10/118 (8.47%)  13 9/132 (6.82%)  11
Pneumothorax   3/133 (2.26%)  3 3/118 (2.54%)  3 3/132 (2.27%)  3
Respiratory Failure   8/133 (6.02%)  8 3/118 (2.54%)  3 10/132 (7.58%)  11
Hemothorax   0/133 (0.00%)  0 1/118 (0.85%)  1 0/132 (0.00%)  0
Hypercapnia   0/133 (0.00%)  0 0/118 (0.00%)  0 2/132 (1.52%)  2
Post-pericardiotomy Syndrome   0/133 (0.00%)  0 1/118 (0.85%)  1 0/132 (0.00%)  0
Shortness of Breath   1/133 (0.75%)  1 0/118 (0.00%)  0 1/132 (0.76%)  1
Skin and subcutaneous tissue disorders       
Wound Dehiscence   3/133 (2.26%)  3 0/118 (0.00%)  0 0/132 (0.00%)  0
Surgical and medical procedures       
Aortic Valve Re-operation   1/133 (0.75%)  1 0/118 (0.00%)  0 0/132 (0.00%)  0
Repair of Aorta   1/133 (0.75%)  1 0/118 (0.00%)  0 0/132 (0.00%)  0
Vascular disorders       
Venous Thromboembolism Event - Deep Vein Thrombosis   2/133 (1.50%)  3 0/118 (0.00%)  0 2/132 (1.52%)  2
Venous Thromboembolism Event - Pulmonary Embolism   0/133 (0.00%)  0 1/118 (0.85%)  1 0/132 (0.00%)  0
Venous Thromboembolism Event - Other*   1/133 (0.75%)  1 0/118 (0.00%)  0 0/132 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Embol-X Embolic Protection Device CardioGard Cannula Standard Cannula
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/133 (33.83%)      47/118 (39.83%)      43/132 (32.58%)    
Cardiac disorders       
Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio   23/133 (17.29%)  24 34/118 (28.81%)  34 24/132 (18.18%)  24
Infections and infestations       
Major Infection - Localized Infection   8/133 (6.02%)  9 6/118 (5.08%)  7 7/132 (5.30%)  7
Renal and urinary disorders       
Acute Kidney Injury - Stage 1   21/133 (15.79%)  22 13/118 (11.02%)  13 21/132 (15.91%)  21
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Annetine C. Gelijns, PhD
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-659-9568
EMail: annetine.gelijns@mssm.edu
Layout table for additonal information
Responsible Party: Annetine Gelijns, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02389894    
Other Study ID Numbers: GCO 08-1078-0009
2U01HL088942-07 ( U.S. NIH Grant/Contract )
First Submitted: March 10, 2015
First Posted: March 17, 2015
Results First Submitted: December 12, 2017
Results First Posted: April 29, 2019
Last Update Posted: April 29, 2019