Neuroprotection in Patients Undergoing Aortic Valve Replacement

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT02389894
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 383
• Locations: 18
• Arms: 3
• Duration (Months): 22.1
• Patients Per Site: 21.3
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis; Brain Infarction; Cerebrovascular Accident; Stroke	Device: Embol-X Embolic Protection Device; Device: CardioGard Cannula	N/A

Detailed Description

This is a multicenter randomized trial in which patients diagnosed with calcific aortic stenosis (AS) with planned AVR will be randomized to 1) the treatment arm of the Edwards Life Science filter and cannula or the filter as a stand alone with any cannula or 2) to the treatment arm of the CardioGard cannula versus 3) standard care in a 1:1:1 ratio.

Study Design

• Study Type: Interventional
• Actual Enrollment: 383 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Neuroprotection In Patients Undergoing Aortic Valve Replacement
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: Embol-X Embolic Protection Device; per the manufacturer's instructions for use (IFU).; Other Names: Edwards Embol-X embolic protection device
Active Comparator: CardioGard Cannula The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.	Device: CardioGard Cannula; CardioGard Cannula, per the manufacturer's instructions for use (IFU).; Other Names: CardioGard Emboli Protection Cannula
No Intervention: Standard Cannula Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction [up to 10 days post procedure]

   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.

Secondary Outcome Measures

1. Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury [up to 30 days]

   The number of patients who have had a clinical ischemic stroke, acute kidney injury (AKI), or death within 30 days of surgery.

2. Number of Patients With Clinically Apparent Stroke at 7 Days [at 7 days]

   The number of patients who experience a clinically apparent stroke by 7 days post-op

3. Presence of Radiographic Infarcts [up to 10 days]

   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

4. Total Infarct Volume [Day 7]

   Total infarct volume measured on day 7 dwMRI.

5. Decline in Overall Neurocognition [baseline and 90 days]

   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.

6. Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days [baseline and 90 days]

   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.

7. Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days [baseline and 90 days]

   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.

8. Decline in Neurocognitive Function in the Executive Function Domain at 90 Day [baseline and 90 days]

   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.

9. Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days [baseline and 90 days]

   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.

10. Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days [baseline and 90 days]

    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.

11. Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days [baseline and 90 days]

    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.

12. Modified Rankin Scale >2 at 90 Days [90 days]

    The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead.

13. Barthel Index <= 80 [90 days]

    An overall score has full range from 0 to 100, with higher scores indicating greater independence.

14. Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days [7 days]

15. Mortality by 90 Days [up to 90 days]

    Incidence of all-cause mortality

16. Length of Stay for Index Hospitalization [up to 90 days]

17. Hospital Readmissions [up to 90 days]

    Rate of hospital readmissions

18. Quality of Life - Physical Health Composite [at 90 days]

    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.

19. Quality of Life - Mental Health Composite [at 90 days]

    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.

20. Number of Participants With Emboli Captured [day 1]

    Assessed by the presence of any debris captured in filter of embolic protection device

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 60 years

• Planned and scheduled surgical aortic valve replacement via a full or minimal-access sternotomy (using central aortic perfusion cannulae) for calcific aortic stenosis with a legally marketed valve

• No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization

• Ability to provide informed consent and comply with the protocol

Exclusion Criteria:

• Contraindication to legally marketed embolic protection devices (e.g. aneurysm of the ascending aorta, aortic trauma, porcelain aorta, known sensitivity to heparin)

• History of clinical stroke within 3 months prior to randomization

• Cardiac catheterization within 3 days of the planned aortic valve replacement

• Cerebral and or aortic arch arteriography or interventions within 3 days of the planned aortic valve replacement

• Active endocarditis at time of randomization

• Anticipated inability to tolerate or contraindication for MRI (e.g., known intolerance of MRI, permanent pacemaker at baseline or expected implantation of a permanent pacemaker)

• Any other concomitant aortic procedure such as root replacement

• Concomitant surgical procedures other than CABG, mitral annuloplasty, left atrial appendage (LAA) excision or exclusion, atrial septal defect (ASD) closure or patent foramen ovale (PFO) closure

• Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization

• Concurrent participation in an interventional (drug or device) trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033
2	Emory University	Atlanta	Georgia	United States	30308
3	University of Maryland	Baltimore	Maryland	United States	21201
4	NIH Heart Center at Suburban Hospital	Bethesda	Maryland	United States	20814
5	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03766
6	Montefiore Einstein Heart Center	Bronx	New York	United States	10467
7	Columbia University Medical Center	New York	New York	United States	10032
8	Mission Hospital	Asheville	North Carolina	United States	28801
9	Duke University	Durham	North Carolina	United States	27710
10	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
11	Ohio State University	Columbus	Ohio	United States	43210
12	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
13	Baylor Research Institute	Plano	Texas	United States	75093
14	University of Virginia	Charlottesville	Virginia	United States	22908
15	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G2B7
16	Toronto General Hospital	Toronto	Ontario	Canada	M5B 1W8
17	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1C8
18	Institut Universitaire de Cardiologie de Quebec (Hopital Laval)	Quebec		Canada	G1V 4G5

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Annetine C Gelijns, PhD, Icahn School of Medicine at Mount Sinai
• Study Chair: Richard Weisel, MD, Toronto General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Annetine Gelijns, Chair, Department of Population Health Science & Policy, Edmond A. Guggenheim Professor of Health Policy Co-Director, InCHOIR, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT02389894
• Other Study ID Numbers: GCO 08-1078-0009; 2U01HL088942-07
• First Posted: Mar 17, 2015
• Last Update Posted: Apr 29, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Annetine Gelijns, Chair, Department of Population Health Science & Policy, Edmond A. Guggenheim Professor of Health Policy Co-Director, InCHOIR, Icahn School of Medicine at Mount Sinai: Embolic Protection Device; Stroke; Brain Infarction; atheroma; Aortic Valve Replacement
• Additional relevant MeSH terms: Stroke; Brain Infarction; Aortic Valve Stenosis; Infarction

Study Results

Participant Flow

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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

Baseline Characteristics

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula	Total
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 Participants	133	118	132	383
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.6 (6.6)	74.6 (6.8)	73.6 (6.7)	73.9 (6.7)
Sex: Female, Male (Count of 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) (Count of Participants)
Hispanic or Latino	4 3%	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) (Count of Participants)
American Indian or Alaska Native	1 0.8%	1 0.8%	0 0%	2 0.5%
Asian	0 0%	0 0%	5 3.8%	5 1.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	6 4.5%	7 5.9%	6 4.5%	19 5%
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%
Unknown or Not Reported	0 0%	2 1.7%	3 2.3%	5 1.3%
Region of Enrollment (participants) [Number]
Canada	19 14.3%	19 16.1%	19 14.4%	57 14.9%
United States	114 85.7%	99 83.9%	113 85.6%	326 85.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	133	118	132
Number (95% Confidence Interval) [percentage of participants]	74.4 55.9%	68.0 57.6%	67.6 51.2%

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
Statistical Test of Hypothesis	p-Value	0.22
	Comments
	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
	Parameter Dispersion	Type: Value:
	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

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
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
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -11.2 to 13.8
	Parameter Dispersion	Type: Value:
	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
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

Outcome Measure Data

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
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.
Measure Participants	132	117	131
Count of Participants [Participants]	44 33.1%	25 21.2%	31 23.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Embol-X Embolic Protection Device, CardioGard Cannula
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	9.7
	Confidence Interval	(2-Sided) 95%; -1.2 to 20.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	The absolute difference was computed as Embol-x minus control

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CardioGard Cannula, Standard Cannula
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-2.8
	Confidence Interval	(2-Sided) 95%; -13.5 to 7.9
	Parameter Dispersion	Type: Value:
	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
Description	The number of patients who experience a clinically apparent stroke by 7 days post-op
Time Frame	at 7 days

Outcome Measure Data

Analysis Population Description

Two patients withdrew prior to day 7

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	133	117	131
Count of Participants [Participants]	11 8.3%	6 5.1%	8 6.1%

4. Secondary Outcome

Title	Presence of Radiographic Infarcts
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

Outcome Measure Data

Analysis Population Description

Denominator includes all patients with day 7 MRI

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	115	101	118
Count of Participants [Participants]	83 62.4%	66 55.9%	76 57.6%

5. Secondary Outcome

Title	Total Infarct Volume
Description	Total infarct volume measured on day 7 dwMRI.
Time Frame	Day 7

Outcome Measure Data

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
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.
Measure Participants	115	101	118
Median (Inter-Quartile Range) [mm^3]	74	42	35

6. Secondary Outcome

Title	Decline in Overall Neurocognition
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	98	81	96
Count of Participants [Participants]	28 21.1%	24 20.3%	31 23.5%

7. Secondary Outcome

Title	Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	117	94	111
Count of Participants [Participants]	31 23.3%	38 32.2%	35 26.5%

8. Secondary Outcome

Title	Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	116	95	112
Count of Participants [Participants]	36 27.1%	25 21.2%	32 24.2%

9. Secondary Outcome

Title	Decline in Neurocognitive Function in the Executive Function Domain at 90 Day
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	103	83	99
Count of Participants [Participants]	19 14.3%	25 21.2%	31 23.5%

10. Secondary Outcome

Title	Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	117	98	113
Count of Participants [Participants]	31 23.3%	28 23.7%	41 31.1%

11. Secondary Outcome

Title	Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	117	96	112
Count of Participants [Participants]	36 27.1%	28 23.7%	38 28.8%

12. Secondary Outcome

Title	Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	110	93	108
Count of Participants [Participants]	43 32.3%	30 25.4%	33 25%

13. Secondary Outcome

Title	Modified Rankin Scale >2 at 90 Days
Description	The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	127	110	123
Count of Participants [Participants]	5 3.8%	7 5.9%	5 3.8%

14. Secondary Outcome

Title	Barthel Index <= 80
Description	An overall score has full range from 0 to 100, with higher scores indicating greater independence.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	123	105	120
Count of Participants [Participants]	2 1.5%	2 1.7%	4 3%

15. Secondary Outcome

Title	Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	123	112	122
Count of Participants [Participants]	10 7.5%	7 5.9%	19 14.4%

16. Secondary Outcome

Title	Mortality by 90 Days
Description	Incidence of all-cause mortality
Time Frame	up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	133	118	132
Count of Participants [Participants]	4 3%	5 4.2%	3 2.3%

17. Secondary Outcome

Title	Length of Stay for Index Hospitalization
Time Frame	up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	133	117	131
Mean (Standard Deviation) [days]	10.4 (7.0)	9.8 (6.7)	10.3 (6.2)

18. Secondary Outcome

Title	Hospital Readmissions
Description	Rate of hospital readmissions
Time Frame	up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	133	117	131
Number [rate per 100-patient-months]	9.3	8.4	7.1

19. Secondary Outcome

Title	Quality of Life - Physical Health Composite
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	122	102	119
Mean (Standard Deviation) [T-Score]	43.0 (10.8)	44.9 (8.3)	44.2 (9.0)

20. Secondary Outcome

Title	Quality of Life - Mental Health Composite
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embol-X Embolic Protection Device	CardioGard Cannula	Standard Cannula
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.
Measure Participants	122	102	119
Mean (Standard Deviation) [T-Score]	55.2 (10.2)	55.4 (8.2)	54.8 (8.0)

21. Secondary Outcome

Title	Number of Participants With Emboli Captured
Description	Assessed by the presence of any debris captured in filter of embolic protection device
Time Frame	day 1

Outcome Measure Data

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
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.
Measure Participants	116	106	0
Count of Participants [Participants]	115 86.5%	79 66.9%	0 0%

Adverse Events

Time Frame	90 Days
Arm/Group Title	Embol-X Embolic Protection Device		CardioGard Cannula		Standard Cannula
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/133 (3%)		5/118 (4.2%)		3/132 (2.3%)
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 (54.1%)		53/118 (44.9%)		54/132 (40.9%)
Blood and lymphatic system disorders
Bleeding - Transfusion > 5 units RBC <24 hours following surgery	0/133 (0%)	0	1/118 (0.8%)	1	1/132 (0.8%)	1
Bleeding - Re-operation for hemorrhage or tamponade	5/133 (3.8%)	5	7/118 (5.9%)	7	5/132 (3.8%)	5
Anemia	1/133 (0.8%)	1	0/118 (0%)	0	0/132 (0%)	0
Disseminated Intravascular Coagulation	1/133 (0.8%)	1	0/118 (0%)	0	0/132 (0%)	0
Epistaxis	0/133 (0%)	0	1/118 (0.8%)	1	1/132 (0.8%)	1
Thrombocytopenia	1/133 (0.8%)	1	0/118 (0%)	0	1/132 (0.8%)	1
Cardiac disorders
Cardiac Arrhythmias - Cardiac arrest	5/133 (3.8%)	6	0/118 (0%)	0	2/132 (1.5%)	2
Cardiac Arrhythmias - Sustained ventricular arrhythmia requiring defibrillation or cardioversion	1/133 (0.8%)	1	0/118 (0%)	0	0/132 (0%)	0
Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio	42/133 (31.6%)	43	22/118 (18.6%)	25	25/132 (18.9%)	25
Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring permanent	7/133 (5.3%)	7	6/118 (5.1%)	6	3/132 (2.3%)	3
Pericardial Fluid Collection	4/133 (3%)	4	1/118 (0.8%)	1	0/132 (0%)	0
Myocardial Infarction - Non-Procedure Related	1/133 (0.8%)	1	0/118 (0%)	0	0/132 (0%)	0
Myocardial Infarction - Peri-CABG	2/133 (1.5%)	2	0/118 (0%)	0	0/132 (0%)	0
Heart Failure	2/133 (1.5%)	2	4/118 (3.4%)	4	8/132 (6.1%)	9
Bradycardia	0/133 (0%)	0	0/118 (0%)	0	2/132 (1.5%)	2
Cardiogenic shock	1/133 (0.8%)	1	0/118 (0%)	0	1/132 (0.8%)	1
Chest Pain	0/133 (0%)	0	0/118 (0%)	0	1/132 (0.8%)	1
Hypertension	1/133 (0.8%)	1	0/118 (0%)	0	0/132 (0%)	0
Orthostatic Hypertension	1/133 (0.8%)	1	0/118 (0%)	0	0/132 (0%)	0
Severe TR requiring TV replacement	0/133 (0%)	0	0/118 (0%)	0	1/132 (0.8%)	1
Syncope	1/133 (0.8%)	1	2/118 (1.7%)	2	0/132 (0%)	0
Endocrine disorders
Adrenal Insufficiency	0/133 (0%)	0	0/118 (0%)	0	1/132 (0.8%)	1
Gastrointestinal disorders
Appendicitis	0/133 (0%)	0	1/118 (0.8%)	1	0/132 (0%)	0
Cholecystitis	0/133 (0%)	0	1/118 (0.8%)	1	0/132 (0%)	0
GI Bleed	2/133 (1.5%)	2	0/118 (0%)	0	2/132 (1.5%)	2
Intra abdominal bleeding	0/133 (0%)	0	0/118 (0%)	0	1/132 (0.8%)	1
Pneumoperitoneum	1/133 (0.8%)	1	0/118 (0%)	0	0/132 (0%)	0
Small bowel obstruction/ileus	2/133 (1.5%)	2	0/118 (0%)	0	4/132 (3%)	4
General disorders
Fever	0/133 (0%)	0	0/118 (0%)	0	1/132 (0.8%)	1
Fluid Overload	1/133 (0.8%)	1	0/118 (0%)	0	0/132 (0%)	0
Foot Pain	0/133 (0%)	0	0/118 (0%)	0	1/132 (0.8%)	1
Weakness	0/133 (0%)	0	1/118 (0.8%)	1	0/132 (0%)	0
Hepatobiliary disorders
Hepatic Dysfunction (Liver injury and Impaired Liver function)	1/133 (0.8%)	1	1/118 (0.8%)	1	0/132 (0%)	0
Infections and infestations
Major Infection - Localized Infection	13/133 (9.8%)	14	7/118 (5.9%)	7	10/132 (7.6%)	11
Major Infection - Endocarditis	0/133 (0%)	0	1/118 (0.8%)	1	0/132 (0%)	0
Major Infection - Sepsis	1/133 (0.8%)	1	2/118 (1.7%)	2	4/132 (3%)	4
Metabolism and nutrition disorders
Dysphagia with PEG tube placement	0/133 (0%)	0	0/118 (0%)	0	1/132 (0.8%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung mass	0/133 (0%)	0	1/118 (0.8%)	1	0/132 (0%)	0
Nervous system disorders
Neurological Dysfunction- Transient Ischemic Attack - TIA	0/133 (0%)	0	0/118 (0%)	0	1/132 (0.8%)	1
Neurological Dysfunction- Ischemic Stroke	3/133 (2.3%)	4	3/118 (2.5%)	3	4/132 (3%)	4
Neurological Dysfunction- Toxic Metabolic Encephalopathy	2/133 (1.5%)	2	1/118 (0.8%)	1	1/132 (0.8%)	1
Neurological Dysfunction- Seizure	0/133 (0%)	0	0/118 (0%)	0	3/132 (2.3%)	3
Neurological Dysfunction- Other Neurological Dysfunction*	1/133 (0.8%)	1	0/118 (0%)	0	3/132 (2.3%)	3
Renal and urinary disorders
Acute Kidney Injury - Stage 1	3/133 (2.3%)	3	1/118 (0.8%)	1	0/132 (0%)	0
Acute Kidney Injury - Stage 2	4/133 (3%)	4	0/118 (0%)	0	2/132 (1.5%)	2
Acute Kidney Injury - Stage 3	7/133 (5.3%)	7	2/118 (1.7%)	2	2/132 (1.5%)	2
Renal Events (Renal Failure)	1/133 (0.8%)	1	0/118 (0%)	0	2/132 (1.5%)	2
Respiratory, thoracic and mediastinal disorders
Pleural Effusion	12/133 (9%)	14	10/118 (8.5%)	13	9/132 (6.8%)	11
Pneumothorax	3/133 (2.3%)	3	3/118 (2.5%)	3	3/132 (2.3%)	3
Respiratory Failure	8/133 (6%)	8	3/118 (2.5%)	3	10/132 (7.6%)	11
Hemothorax	0/133 (0%)	0	1/118 (0.8%)	1	0/132 (0%)	0
Hypercapnia	0/133 (0%)	0	0/118 (0%)	0	2/132 (1.5%)	2
Post-pericardiotomy Syndrome	0/133 (0%)	0	1/118 (0.8%)	1	0/132 (0%)	0
Shortness of Breath	1/133 (0.8%)	1	0/118 (0%)	0	1/132 (0.8%)	1
Skin and subcutaneous tissue disorders
Wound Dehiscence	3/133 (2.3%)	3	0/118 (0%)	0	0/132 (0%)	0
Surgical and medical procedures
Aortic Valve Re-operation	1/133 (0.8%)	1	0/118 (0%)	0	0/132 (0%)	0
Repair of Aorta	1/133 (0.8%)	1	0/118 (0%)	0	0/132 (0%)	0
Vascular disorders
Venous Thromboembolism Event - Deep Vein Thrombosis	2/133 (1.5%)	3	0/118 (0%)	0	2/132 (1.5%)	2
Venous Thromboembolism Event - Pulmonary Embolism	0/133 (0%)	0	1/118 (0.8%)	1	0/132 (0%)	0
Venous Thromboembolism Event - Other*	1/133 (0.8%)	1	0/118 (0%)	0	0/132 (0%)	0
Other (Not Including 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	45/133 (33.8%)		47/118 (39.8%)		43/132 (32.6%)
Cardiac disorders
Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio	23/133 (17.3%)	24	34/118 (28.8%)	34	24/132 (18.2%)	24
Infections and infestations
Major Infection - Localized Infection	8/133 (6%)	9	6/118 (5.1%)	7	7/132 (5.3%)	7
Renal and urinary disorders
Acute Kidney Injury - Stage 1	21/133 (15.8%)	22	13/118 (11%)	13	21/132 (15.9%)	21

Limitations/Caveats

[Not Specified]

More Information

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.