An interventional study of Embol-X Embolic Protection Device and CardioGard Cannula in Aortic Stenosis, Brain Infarction and Cerebrovascular Accident, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 18 sites in 2 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-04-29.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Prevention
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
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.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's enrollment of 383 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
Device: CardioGard Cannula
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
per the manufacturer's instructions for use (IFU).
Also known as: Edwards Embol-X embolic protection device
CardioGard Cannula, per the manufacturer's instructions for use (IFU).
Also known as: CardioGard Emboli Protection Cannula
Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction
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
Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury
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
Number of Patients With Clinically Apparent Stroke at 7 Days
The number of patients who experience a clinically apparent stroke by 7 days post-op
Time frame: at 7 days
Presence of Radiographic Infarcts
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
Total Infarct Volume
Total infarct volume measured on day 7 dwMRI.
Time frame: Day 7
Decline in Overall Neurocognition
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
Decline in Neurocognitive Function in the Verbal Memory Domain at 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.
Time frame: baseline and 90 days
Decline in Neurocognitive Function in the Visual Memory Domain at 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.
Time frame: baseline and 90 days
Decline in Neurocognitive Function in the Executive Function Domain at 90 Day
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
Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 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.
Time frame: baseline and 90 days
Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 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.
Time frame: baseline and 90 days
Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 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.
Time frame: baseline and 90 days
Modified Rankin Scale >2 at 90 Days
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
Barthel Index <= 80
An overall score has full range from 0 to 100, with higher scores indicating greater independence.
Time frame: 90 days
Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days
Time frame: 7 days
Mortality by 90 Days
Incidence of all-cause mortality
Time frame: up to 90 days
Length of Stay for Index Hospitalization
Time frame: up to 90 days
Hospital Readmissions
Rate of hospital readmissions
Time frame: up to 90 days
Quality of Life - Physical Health Composite
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
Quality of Life - Mental Health Composite
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
Number of Participants With Emboli Captured
Assessed by the presence of any debris captured in filter of embolic protection device
Time frame: day 1
| Milestone | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Started | 133 | 118 | 132 |
| Completed | 125 | 108 | 123 |
| Not completed | 8 | 10 | 9 |
| Withdrew: Death | 4 | 5 | 3 |
| Withdrew: Withdrawal by subject | 2 | 4 | 5 |
| Withdrew: Lost to follow-up | 2 | 1 | 1 |
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.
| percentage of participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction | 74.4 (66.4 to 82.5) | 68.0 (59.1 to 76.8) | 67.6 (58.8 to 76.4) |
The number of patients who have had a clinical ischemic stroke, acute kidney injury (AKI), or death within 30 days of surgery.
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury | 44 | 25 | 31 |
The number of patients who experience a clinically apparent stroke by 7 days post-op
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Number of Patients With Clinically Apparent Stroke at 7 Days | 11 | 6 | 8 |
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
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Presence of Radiographic Infarcts | 83 | 66 | 76 |
Total infarct volume measured on day 7 dwMRI.
| mm^3 | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Total Infarct Volume | 74 (0 to 322) | 42 (0 to 151) | 35 (0 to 168) |
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.
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Decline in Overall Neurocognition | 28 | 24 | 31 |
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.
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days | 31 | 38 | 35 |
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.
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days | 36 | 25 | 32 |
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.
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Decline in Neurocognitive Function in the Executive Function Domain at 90 Day | 19 | 25 | 31 |
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.
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days | 31 | 28 | 41 |
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.
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days | 36 | 28 | 38 |
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.
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days | 43 | 30 | 33 |
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.
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Modified Rankin Scale >2 at 90 Days | 5 | 7 | 5 |
An overall score has full range from 0 to 100, with higher scores indicating greater independence.
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Barthel Index <= 80 | 2 | 2 | 4 |
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days | 10 | 7 | 19 |
Incidence of all-cause mortality
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Mortality by 90 Days | 4 | 5 | 3 |
| days | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Length of Stay for Index Hospitalization | 10.4 ± 7.0 | 9.8 ± 6.7 | 10.3 ± 6.2 |
Rate of hospital readmissions
| rate per 100-patient-months | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Hospital Readmissions | 9.3 | 8.4 | 7.1 |
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.
| T-Score | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Quality of Life - Physical Health Composite | 43.0 ± 10.8 | 44.9 ± 8.3 | 44.2 ± 9.0 |
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.
| T-Score | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Quality of Life - Mental Health Composite | 55.2 ± 10.2 | 55.4 ± 8.2 | 54.8 ± 8.0 |
Assessed by the presence of any debris captured in filter of embolic protection device
| Participants | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Number of Participants With Emboli Captured | 115 | 79 | 0 |
Collected over 90 Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Embol-X Embolic Protection Device | 4/133 (3%) | 72/133 (54.1%) | 45/133 (33.8%) |
| CardioGard Cannula | 5/118 (4.2%) | 53/118 (44.9%) | 47/118 (39.8%) |
| Standard Cannula | 3/132 (2.3%) | 54/132 (40.9%) | 43/132 (32.6%) |
| Event | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversioCardiac disorders | 42/133 | 22/118 | 25/132 |
| Major Infection - Localized InfectionInfections and infestations | 13/133 | 7/118 | 10/132 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 12/133 | 10/118 | 9/132 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 8/133 | 3/118 | 10/132 |
| Heart FailureCardiac disorders | 2/133 | 4/118 | 8/132 |
| Bleeding - Re-operation for hemorrhage or tamponadeBlood and lymphatic system disorders | 5/133 | 7/118 | 5/132 |
| Acute Kidney Injury - Stage 3Renal and urinary disorders | 7/133 | 2/118 | 2/132 |
| Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring permanentCardiac disorders | 7/133 | 6/118 | 3/132 |
| Cardiac Arrhythmias - Cardiac arrestCardiac disorders | 5/133 | 0/118 | 2/132 |
| Major Infection - SepsisInfections and infestations | 1/133 | 2/118 | 4/132 |
| Event | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula |
|---|---|---|---|
| Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversioCardiac disorders | 23/133 | 34/118 | 24/132 |
| Acute Kidney Injury - Stage 1Renal and urinary disorders | 21/133 | 13/118 | 21/132 |
| Major Infection - Localized InfectionInfections and infestations | 8/133 | 6/118 | 7/132 |
| Age, Continuous(years) | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula | Total |
|---|---|---|---|---|
| Mean | 73.6 ± 6.6 | 74.6 ± 6.8 | 73.6 ± 6.7 | 73.9 ± 6.7 |
| Sex: Female, Male(Participants) | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula | Total |
|---|---|---|---|---|
| Female | 52 | 49 | 46 | 147 |
| Male | 81 | 69 | 86 | 236 |
| Ethnicity (NIH/OMB)(Participants) | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula | Total |
|---|---|---|---|---|
| Hispanic or Latino | 4 | 5 | 8 | 17 |
| Not Hispanic or Latino | 127 | 110 | 121 | 358 |
| Unknown or Not Reported | 2 | 3 | 3 | 8 |
| Race (NIH/OMB)(Participants) | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 0 | 2 |
| Asian | 0 | 0 | 5 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 7 | 6 | 19 |
| White | 126 | 108 | 118 | 352 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 3 | 5 |
| Region of Enrollment(participants) | Embol-X Embolic Protection Device | CardioGard Cannula | Standard Cannula | Total |
|---|---|---|---|---|
| Canada | 19 | 19 | 19 | 57 |
| United States | 114 | 99 | 113 | 326 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai →