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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
383
per the manufacturer's instructions for use (IFU).
CardioGard Cannula, per the manufacturer's instructions for use (IFU).
University of Southern California
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
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.
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University of Maryland
Baltimore, Maryland, United States
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Einstein Heart Center
The Bronx, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
...and 8 more locations
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