xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06027788</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY-23-00417</org_study_id>
      <secondary_id>5U01HL088942-16</secondary_id>
      <nct_id>NCT06027788</nct_id>
    </id_info>
    <brief_title>CTSN Embolic Protection Trial</brief_title>
    <official_title>Embolic Protection in Patients Undergoing High-Risk Valve Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Icahn School of Medicine at Mount Sinai</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic&#xD;
        Protection Cannula in high-risk valve surgery patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, multicenter, randomized controlled clinical trial that will evaluate&#xD;
        the effectiveness and safety of the CardioGard embolic protection cannula compared to a&#xD;
        standard cannula. The enrollment period is expected to last 30 months, and all patients will&#xD;
        be followed for 12 months post procedure.&#xD;
  &#xD;
        RANDOMIZATION Patients will be randomized 1:1 to the embolic protection device or to a&#xD;
        standard cannula in the operating room (OR) immediately after sternotomy and confirmation by&#xD;
        the surgical team of the patient's suitability for the proposed intervention (CardioGard&#xD;
        embolic protection device). Randomization will be with equal allocation and stratified by&#xD;
        site and by procedure (i.e., isolated valve surgery or combined procedures, such as double&#xD;
        valve or valve plus coronary artery bypass grafting, CABG). The randomization assignment will&#xD;
        be controlled centrally and performed through a web-based data collection system that&#xD;
        automates the delivery of the randomization codes. From the point of treatment assignment,&#xD;
        primary efficacy will be analyzed by intention-to-treat; that is, the patients will be&#xD;
        grouped by their assignments at randomization regardless of whether or not they actually&#xD;
        received the treatment to which they were assigned.&#xD;
  &#xD;
        STUDY POPULATION The patient population for this trial consists of patients age ≥ 60&#xD;
        undergoing different types of valve surgery with or without CABG via full or minimal-access&#xD;
        sternotomy using legally marketed valve(s). Specific inclusion and exclusion criteria are&#xD;
        listed below. All patients who meet the eligibility criteria may be included in the study&#xD;
        regardless of gender, race, or ethnicity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the OR immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device).</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The nature of the study precludes masking surgeons from treatment assignment. Investigators will, however, be blinded to all data from other clinical sites, except serious unexpected adverse events possibly or probably related to the intervention for Institutional Review Board (IRB)/Research Ethics Board (REB) reporting purposes. Patients will be blinded as to treatment assignment. All neurocognitive scoring and delirium assessments will be analyzed by neurocognitive core laboratory personnel who will be blinded to treatment assignment and clinical outcomes.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)</measure>
      <time_frame>within 3 days post-randomization</time_frame>
      <description>The combined number of patients who experience clinical ischemic strokes and acute kidney injuries that have occurred within 3 days post-randomization.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients who experience of death and delirium</measure>
      <time_frame>by 7 days post-randomization</time_frame>
      <description>The combined number of patients who experience death and delirium by 7 days post-randomization (with a blanking period for delirium of days 1 and 2 post-operatively).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who experience a clinical ischemic stroke</measure>
      <time_frame>within 3 days post-randomization</time_frame>
      <description>The proportion of patients who experience a clinical ischemic stroke within 3 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who experience a clinical ischemic stroke</measure>
      <time_frame>within 7 days post-randomization</time_frame>
      <description>The proportion of patients who experience a clinical ischemic stroke within 7 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with disabling clinical stroke</measure>
      <time_frame>within 3 days post-randomization</time_frame>
      <description>Number of patients with disabling clinical stroke within 3 days post-randomization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with disabling clinical stroke</measure>
      <time_frame>within 7 days post-randomization</time_frame>
      <description>Number of patients with disabling clinical stroke within 7 days post-randomization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)</measure>
      <time_frame>within 3 days post-randomization</time_frame>
      <description>Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery.&#xD;
  Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment.&#xD;
  These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)</measure>
      <time_frame>within 7 days post-randomization</time_frame>
      <description>Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery.&#xD;
  Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment.&#xD;
  These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2</measure>
      <time_frame>at baseline</time_frame>
      <description>Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at baseline days.&#xD;
  The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment.&#xD;
  0 - No symptoms.&#xD;
  - No significant disability. Able to carry out all usual activities, despite some symptoms.&#xD;
  - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.&#xD;
  3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance.&#xD;
  5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.&#xD;
  6 - Dead.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2</measure>
      <time_frame>at 30 days</time_frame>
      <description>Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 30 days.&#xD;
  The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment.&#xD;
  0 - No symptoms.&#xD;
  - No significant disability. Able to carry out all usual activities, despite some symptoms.&#xD;
  - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.&#xD;
  3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance.&#xD;
  5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.&#xD;
  6 - Dead.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2</measure>
      <time_frame>at 90 days</time_frame>
      <description>Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 90 days.&#xD;
  The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment.&#xD;
  0 - No symptoms.&#xD;
  - No significant disability. Able to carry out all usual activities, despite some symptoms.&#xD;
  - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.&#xD;
  3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance.&#xD;
  5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.&#xD;
  6 - Dead.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA) Score</measure>
      <time_frame>at baseline</time_frame>
      <description>Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at presurgical baseline.&#xD;
  The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above was considered normal. Higher values represent a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA) Score</measure>
      <time_frame>at 90 days</time_frame>
      <description>Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 90 days.&#xD;
  The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA) Score</measure>
      <time_frame>at 12 months</time_frame>
      <description>Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 12 months.&#xD;
  The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hopkins Verbal Learning Test-Revised (HVLT-R) (verbal learning and memory) Score</measure>
      <time_frame>at baseline</time_frame>
      <description>HVLT-R is a structured word-list memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score for immediate recall and learning. Participants are also asked to recall learned word-list items after a 20-minute delay, yielding a delayed recall score. Participants also perform a subsequent recognition task where they affirm or deny recognition of the word-list materials (from a larger group of 12 target and 12 foil words), the results of which provide a score for recognition discriminability (i.e., target hits - foil misses). The scores for all of these HVLT-R variables are converted to standardized &quot;T&quot; scores using normative data. The possible &quot;T&quot; score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hopkins Verbal Learning Test-Revised (verbal learning and memory) Score</measure>
      <time_frame>at 90 days post-randomization</time_frame>
      <description>Hopkins Verbal Learning Test-Revised (HVLT-R) is a structured word-list memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score for immediate recall and learning. Participants are also asked to recall learned word-list items after a 20-minute delay, yielding a delayed recall score. Participants also perform a subsequent recognition task where they affirm or deny recognition of the word-list materials (from a larger group of 12 target and 12 foil words), the results of which provide a score for recognition discriminability (i.e., target hits - foil misses). The scores for all of these HVLT-R variables are converted to standardized &quot;T&quot; scores using normative data. The possible &quot;T&quot; score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hopkins Verbal Learning Test-Revised (verbal learning and memory) Score</measure>
      <time_frame>at 12 months post-randomization</time_frame>
      <description>Hopkins Verbal Learning Test-Revised (HVLT-R) is a structured word-list memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score for immediate recall and learning. Participants are also asked to recall learned word-list items after a 20-minute delay, yielding a delayed recall score. Participants also perform a subsequent recognition task where they affirm or deny recognition of the word-list materials (from a larger group of 12 target and 12 foil words), the results of which provide a score for recognition discriminability (i.e., target hits - foil misses). The scores for all of these HVLT-R variables are converted to standardized &quot;T&quot; scores using normative data. The possible &quot;T&quot; score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief Visuospatial Memory Test - Revised (visual learning &amp; memory and constructional praxis)</measure>
      <time_frame>at 90 days post-procedure</time_frame>
      <description>Analogous to the HVLT-R, the Brief Visuospatial Memory Test (BVMT-R) assesses visual learning and memory by measuring how well individuals can recall a page of six line drawings presented visually for 10 seconds over three repetition trials. Examinee totals from the three repetition trials is taken as a measure of visual short-term learning and memory, and after a 20-minute delay, examinees are asked to reproduce as many as possible of the previously presented line drawings (assessing long-term visual memory retention and recall). Examinees are then shown 12 line drawings, six of which were the line drawings they were asked to reproduce earlier and six new drawings, and examinees are asked if they recognize the line drawings as ones they have seen before (assessing long-term visual recognition memory). Raw scores are converted to T-scores, normed by age and sex. A higher T-score representing a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral Trail Making Test - Parts A and B (executive function)</measure>
      <time_frame>at baseline</time_frame>
      <description>The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the &quot;trail.&quot; If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral Trail Making Test - Parts A and B (executive function)</measure>
      <time_frame>at 90 days post-randomization</time_frame>
      <description>The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the &quot;trail.&quot; If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral Trail Making Test - Parts A and B (executive function)</measure>
      <time_frame>at 12 months post-randomization</time_frame>
      <description>The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the &quot;trail.&quot; If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)</measure>
      <time_frame>baseline</time_frame>
      <description>The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for &quot;digit span&quot; range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)</measure>
      <time_frame>at 90 days post-randomization</time_frame>
      <description>The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for &quot;digit span&quot; range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)</measure>
      <time_frame>at 12 months post-randomization</time_frame>
      <description>The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for &quot;digit span&quot; range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Symbol Substitution Test (processing speed)</measure>
      <time_frame>at baseline</time_frame>
      <description>The WAIS-R Digit Symbol Substitution Test (DSST) is a paper-and-pencil cognitive test that consist of number-symbol pairs. It requires the examinee to copy, into spaces below rows of numbers, the symbols that are paired to each number. The DSST score is the number of digits coded correctly in a 90-second test period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)</measure>
      <time_frame>at baseline</time_frame>
      <description>The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)</measure>
      <time_frame>at 90 days post-randomization</time_frame>
      <description>The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)</measure>
      <time_frame>at 12 months post-randomization</time_frame>
      <description>The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Delirium</measure>
      <time_frame>first 7 days post-randomization</time_frame>
      <description>The incidence of delirium will be assessed daily by the Confusion Assessment Method (3D-CAM or CAM-ICU for intubated patients) during the first 7 days post-randomization.&#xD;
  The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4 and involves the presence/absence of delirium, but not its severity. Any error or behavioral observation consistent with a delirium feature means that feature is present.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Delirium</measure>
      <time_frame>first 7 days post-randomization</time_frame>
      <description>The duration of delirium will be measured as the number of days with positive CAM assessments by 7 days post-randomization.&#xD;
  The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Severity of Delirium</measure>
      <time_frame>first 7 days post-randomization</time_frame>
      <description>The severity of delirium will be measured during daily screening using standardized algorithms for extracting symptom severity from the 3D-CAM and CAM-ICU.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Patients who experience Acute kidney injury (AKI)</measure>
      <time_frame>within -7 days post-randomization</time_frame>
      <description>Number of Patients who experience Acute kidney injury will be assessed within 7 days post-randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause mortality</measure>
      <time_frame>within 90 days post-randomization</time_frame>
      <description>All-cause mortality within 90 days post-randomization will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause mortality</measure>
      <time_frame>within 12 months post-randomization</time_frame>
      <description>All-cause mortality within 12-months post-randomization will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of Index Hospitalization</measure>
      <time_frame>at hospital discharge, up to 30 days</time_frame>
      <description>Overall length of stay for the index hospitalization post-randomization will be measured and broken down by days spent in the ICU versus days not in the ICU.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Discharge disposition</measure>
      <time_frame>at hospital discharge, up to 30 days</time_frame>
      <description>Discharge disposition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmissions rates</measure>
      <time_frame>first 90 days</time_frame>
      <description>Readmission rates will be calculated for the first 90 days following randomization. Hospitalizations will be classified for all causes including for cardiovascular readmissions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmissions rates</measure>
      <time_frame>up to 1 year post-randomization</time_frame>
      <description>Readmission rates will be calculated for the duration of follow-up, out to 1 year. Hospitalizations will be classified for all causes including for cardiovascular readmissions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days Alive out of Hospital</measure>
      <time_frame>within 90 days post-randomization</time_frame>
      <description>Days alive out of hospital and nursing/rehab facilities within 90 days after randomization</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">842</enrollment>
    <condition>Delirium</condition>
    <condition>Ischemic Stroke</condition>
    <condition>Acute Kidney Injury</condition>
    <arm_group>
      <arm_group_label>CardioGard Embolic Protection Cannula</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In patients assigned to the embolic protection device group, the CardioGard Embolic Protection Cannula is used instead, according to the manufacturer's instructions for use (IFU).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Aortic Cannula</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>In patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CardioGard Embolic Protection Cannula</intervention_name>
      <description>The CardioGard embolic protection cannula is a device that combines the function of a standard aortic cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The device is comprised of 2 hollow tubes. The first tube is the standard main forward-flow tube to return oxygenated blood to the patient's aorta. The second tube attached to an existing bypass vent port, is a novel element located posteriorly to the main tube; its function is to facilitate blood and particle suction by directing the blood back to the reservoir of the coronary bypass machine, while the retrieved embolic debris is eliminated through the filter of the venous reservoir.</description>
      <arm_group_label>CardioGard Embolic Protection Cannula</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Standard Aortic Cannula</intervention_name>
      <description>An aortic cannula is a device that is used routinely during cardiac surgery to return oxygenated blood from the cardiac bypass machine into the patient's aorta.</description>
      <arm_group_label>Standard Aortic Cannula</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 60 years&#xD;
  &#xD;
            -  Planned de novo or redo:&#xD;
  &#xD;
                 -  Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory&#xD;
                    arrest is not required) ± CABG&#xD;
  &#xD;
                 -  Mitral valve replacement (MVR) ± CABG&#xD;
  &#xD;
                 -  Mitral Valve Repair + CABG,&#xD;
  &#xD;
                 -  Double/Triple valve surgery ± CABG; Ross procedure These procedures can be done&#xD;
                    via a full or minimal-access sternotomy (using central aortic perfusion cannulae)&#xD;
                    with legally marketed valve(s), and can be done in combination with an left&#xD;
                    atrial appendage (LAA) closure/excision or partial/complete Maze procedure.&#xD;
  &#xD;
            -  No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin&#xD;
               scale (mRS) ≤2 within 7 days prior to randomization&#xD;
  &#xD;
            -  Ability to provide informed consent and comply with the protocol Exclusion Criteria&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of clinical stroke within 3 months prior to randomization&#xD;
  &#xD;
            -  Cerebral and or aortic arch arteriography or interventions within 3 days of the&#xD;
               planned procedure&#xD;
  &#xD;
            -  Coronary catheterization within 3 days of the planned procedure&#xD;
  &#xD;
            -  Active endocarditis at time of randomization with vegetation criteria&#xD;
  &#xD;
            -  Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to&#xD;
               randomization&#xD;
  &#xD;
            -  Participation in an interventional (drug or device) trial&#xD;
  &#xD;
            -  Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve&#xD;
               repair and tricuspid valve repair&#xD;
  &#xD;
            -  Anticipated requirement for prolonged mechanical ventilation greater than 48 hours&#xD;
               after surgery in the opinion of the investigator&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Annetine C. Gelijns, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ellen Moquete</last_name>
      <phone>212-659-9651</phone>
      <email>ellen.moquete@mountsinai.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Claudia Merlin</last_name>
      <phone>917-494-2387</phone>
      <email>Claudia.merlin@mountsinai.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHI St. Vincent Heart Institute</name>
        <address>
          <city>North Little Rock</city>
          <state>Arkansas</state>
          <zip>72117</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lynn Bass</last_name>
        <email>Lynn.bass@commonspirit.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Keck Hospital of the University of Southern California</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90033</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Edward Lozano</last_name>
        <email>edwardlo@med.usc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Indiana Ohio Heart</name>
        <address>
          <city>Thousand Oaks</city>
          <state>California</state>
          <zip>91360</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Barbara Anderson</last_name>
        <email>banderson2@lutheran-hosp.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Emory University</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30322</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Sonya Mathewson</last_name>
        <email>sbmathe@emory.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Indiana University</name>
        <address>
          <city>Bloomington</city>
          <state>Indiana</state>
          <zip>47405</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Srdjan Kurbalija</last_name>
        <email>skurbalija@iuhealth.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ochsner Clinic</name>
        <address>
          <city>New Orleans</city>
          <state>Louisiana</state>
          <zip>70506</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Nicolle Scholl</last_name>
        <email>nicolle.scholl@ochsner.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Maine Medical Center</name>
        <address>
          <city>Portland</city>
          <state>Maine</state>
          <zip>04102</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Monica Palmeri</last_name>
        <email>Monica.Palmeri@mainehealth.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Johns Hopkins Medicine</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21287</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lisa Fornaresio, PhD</last_name>
        <email>lisa.fornaresio@jhmi.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Maryland</name>
        <address>
          <city>College Park</city>
          <state>Maryland</state>
          <zip>20742</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kaitlyn Masih</last_name>
        <email>KMasih@som.umaryland.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Massachusetts General Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ana M Pico</last_name>
        <email>APICO@mgh.harvard.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Michigan</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Bret Weber</last_name>
        <email>bwe@med.umich.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Saint Luke's Hospital of Kansas City</name>
        <address>
          <city>Kansas City</city>
          <state>Missouri</state>
          <zip>64111</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Dartmouth-Hitchcock Medical Center</name>
        <address>
          <city>Lebanon</city>
          <state>New Hampshire</state>
          <zip>03756</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Montefiore Medical Center</name>
        <address>
          <city>Bronx</city>
          <state>New York</state>
          <zip>10467</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Agnieszka Siemienik</last_name>
        <email>asiemien@montefiore.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Northwell Health</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>21287</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Shangyi Liu</last_name>
        <email>sliu11@northwell.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Duke University</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27710</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Shelly Fincannon</last_name>
        <email>shelly.fincannon@duke.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cleveland Clinic</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Anna M Simmons</last_name>
        <email>SIMMONA8@ccf.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital of the University of Pennsylvania</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Mary L Mayer</last_name>
        <email>marylou.mayer@uphs.upenn.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hôpital Laval</name>
        <address>
          <city>Quebec City</city>
          <state>Quebec</state>
          <zip>QC G1V 4G5</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Annie Bergeron</last_name>
        <email>annie.bergeron@criucpq.ulaval.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
      <investigator_full_name>Annetine Gelijns</investigator_full_name>
      <investigator_title>Professor of Health Policy, Chair Department of Health Evidence &amp; Policy</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Acute Kidney Injury</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>De-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.</ipd_time_frame>
      <ipd_access_criteria>Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link to be included in the URL field below).</ipd_access_criteria>
      <ipd_url>https://biolincc.nhlbi.nih.gov/studies/</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06027788
  org study id: STUDY-23-00417
  secondary id: 5U01HL088942-16
  nct id: NCT06027788
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic
        Protection Cannula in high-risk valve surgery patients.
  This is a prospective, multicenter, randomized controlled clinical trial that will evaluate
        the effectiveness and safety of the CardioGard embolic protection cannula compared to a
        standard cannula. The enrollment period is expected to last 30 months, and all patients will
        be followed for 12 months post procedure.
  
        RANDOMIZATION Patients will be randomized 1:1 to the embolic protection device or to a
        standard cannula in the operating room (OR) immediately after sternotomy and confirmation by
        the surgical team of the patient's suitability for the proposed intervention (CardioGard
        embolic protection device). Randomization will be with equal allocation and stratified by
        site and by procedure (i.e., isolated valve surgery or combined procedures, such as double
        valve or valve plus coronary artery bypass grafting, CABG). The randomization assignment will
        be controlled centrally and performed through a web-based data collection system that
        automates the delivery of the randomization codes. From the point of treatment assignment,
        primary efficacy will be analyzed by intention-to-treat; that is, the patients will be
        grouped by their assignments at randomization regardless of whether or not they actually
        received the treatment to which they were assigned.
  
        STUDY POPULATION The patient population for this trial consists of patients age ≥ 60
        undergoing different types of valve surgery with or without CABG via full or minimal-access
        sternotomy using legally marketed valve(s). Specific inclusion and exclusion criteria are
        listed below. All patients who meet the eligibility criteria may be included in the study
        regardless of gender, race, or ethnicity.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the OR immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device).
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: The nature of the study precludes masking surgeons from treatment assignment. Investigators will, however, be blinded to all data from other clinical sites, except serious unexpected adverse events possibly or probably related to the intervention for Institutional Review Board (IRB)/Research Ethics Board (REB) reporting purposes. Patients will be blinded as to treatment assignment. All neurocognitive scoring and delirium assessments will be analyzed by neurocognitive core laboratory personnel who will be blinded to treatment assignment and clinical outcomes.
  measure: Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
  time frame: within 3 days post-randomization
  description: The combined number of patients who experience clinical ischemic strokes and acute kidney injuries that have occurred within 3 days post-randomization.
  measure: Number of patients who experience of death and delirium
  time frame: by 7 days post-randomization
  description: The combined number of patients who experience death and delirium by 7 days post-randomization (with a blanking period for delirium of days 1 and 2 post-operatively).
  measure: Proportion of patients who experience a clinical ischemic stroke
  time frame: within 3 days post-randomization
  description: The proportion of patients who experience a clinical ischemic stroke within 3 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
  measure: Proportion of patients who experience a clinical ischemic stroke
  time frame: within 7 days post-randomization
  description: The proportion of patients who experience a clinical ischemic stroke within 7 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
  measure: Number of patients with disabling clinical stroke
  time frame: within 3 days post-randomization
  description: Number of patients with disabling clinical stroke within 3 days post-randomization
  measure: Number of patients with disabling clinical stroke
  time frame: within 7 days post-randomization
  description: Number of patients with disabling clinical stroke within 7 days post-randomization
  measure: Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
  time frame: within 3 days post-randomization
  description: Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery.
  Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment.
  These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.
  measure: Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
  time frame: within 7 days post-randomization
  description: Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery.
  Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment.
  These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.
  measure: Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
  time frame: at baseline
  description: Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at baseline days.
  The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment.
  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.
  3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance.
  5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6 - Dead.
  measure: Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
  time frame: at 30 days
  description: Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 30 days.
  The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment.
  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.
  3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance.
  5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6 - Dead.
  measure: Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
  time frame: at 90 days
  description: Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 90 days.
  The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment.
  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.
  3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance.
  5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6 - Dead.
  measure: Montreal Cognitive Assessment (MoCA) Score
  time frame: at baseline
  description: Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at presurgical baseline.
  The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above was considered normal. Higher values represent a better outcome.
  measure: Montreal Cognitive Assessment (MoCA) Score
  time frame: at 90 days
  description: Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 90 days.
  The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.
  measure: Montreal Cognitive Assessment (MoCA) Score
  time frame: at 12 months
  description: Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 12 months.
  The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.
  measure: Hopkins Verbal Learning Test-Revised (HVLT-R) (verbal learning and memory) Score
  time frame: at baseline
  description: HVLT-R is a structured word-list memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score for immediate recall and learning. Participants are also asked to recall learned word-list items after a 20-minute delay, yielding a delayed recall score. Participants also perform a subsequent recognition task where they affirm or deny recognition of the word-list materials (from a larger group of 12 target and 12 foil words), the results of which provide a score for recognition discriminability (i.e., target hits - foil misses). The scores for all of these HVLT-R variables are converted to standardized "T" scores using normative data. The possible "T" score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome
  measure: Hopkins Verbal Learning Test-Revised (verbal learning and memory) Score
  time frame: at 90 days post-randomization
  description: Hopkins Verbal Learning Test-Revised (HVLT-R) is a structured word-list memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score for immediate recall and learning. Participants are also asked to recall learned word-list items after a 20-minute delay, yielding a delayed recall score. Participants also perform a subsequent recognition task where they affirm or deny recognition of the word-list materials (from a larger group of 12 target and 12 foil words), the results of which provide a score for recognition discriminability (i.e., target hits - foil misses). The scores for all of these HVLT-R variables are converted to standardized "T" scores using normative data. The possible "T" score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome.
  measure: Hopkins Verbal Learning Test-Revised (verbal learning and memory) Score
  time frame: at 12 months post-randomization
  description: Hopkins Verbal Learning Test-Revised (HVLT-R) is a structured word-list memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score for immediate recall and learning. Participants are also asked to recall learned word-list items after a 20-minute delay, yielding a delayed recall score. Participants also perform a subsequent recognition task where they affirm or deny recognition of the word-list materials (from a larger group of 12 target and 12 foil words), the results of which provide a score for recognition discriminability (i.e., target hits - foil misses). The scores for all of these HVLT-R variables are converted to standardized "T" scores using normative data. The possible "T" score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome.
  measure: Brief Visuospatial Memory Test - Revised (visual learning & memory and constructional praxis)
  time frame: at 90 days post-procedure
  description: Analogous to the HVLT-R, the Brief Visuospatial Memory Test (BVMT-R) assesses visual learning and memory by measuring how well individuals can recall a page of six line drawings presented visually for 10 seconds over three repetition trials. Examinee totals from the three repetition trials is taken as a measure of visual short-term learning and memory, and after a 20-minute delay, examinees are asked to reproduce as many as possible of the previously presented line drawings (assessing long-term visual memory retention and recall). Examinees are then shown 12 line drawings, six of which were the line drawings they were asked to reproduce earlier and six new drawings, and examinees are asked if they recognize the line drawings as ones they have seen before (assessing long-term visual recognition memory). Raw scores are converted to T-scores, normed by age and sex. A higher T-score representing a better outcome.
  measure: Oral Trail Making Test - Parts A and B (executive function)
  time frame: at baseline
  description: The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
  measure: Oral Trail Making Test - Parts A and B (executive function)
  time frame: at 90 days post-randomization
  description: The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
  measure: Oral Trail Making Test - Parts A and B (executive function)
  time frame: at 12 months post-randomization
  description: The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
  measure: Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
  time frame: baseline
  description: The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
  measure: Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
  time frame: at 90 days post-randomization
  description: The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
  measure: Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
  time frame: at 12 months post-randomization
  description: The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
  measure: Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Symbol Substitution Test (processing speed)
  time frame: at baseline
  description: The WAIS-R Digit Symbol Substitution Test (DSST) is a paper-and-pencil cognitive test that consist of number-symbol pairs. It requires the examinee to copy, into spaces below rows of numbers, the symbols that are paired to each number. The DSST score is the number of digits coded correctly in a 90-second test period
  measure: Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
  time frame: at baseline
  description: The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
  measure: Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
  time frame: at 90 days post-randomization
  description: The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
  measure: Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
  time frame: at 12 months post-randomization
  description: The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
  measure: Incidence of Delirium
  time frame: first 7 days post-randomization
  description: The incidence of delirium will be assessed daily by the Confusion Assessment Method (3D-CAM or CAM-ICU for intubated patients) during the first 7 days post-randomization.
  The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4 and involves the presence/absence of delirium, but not its severity. Any error or behavioral observation consistent with a delirium feature means that feature is present.
  measure: Duration of Delirium
  time frame: first 7 days post-randomization
  description: The duration of delirium will be measured as the number of days with positive CAM assessments by 7 days post-randomization.
  The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
  measure: Severity of Delirium
  time frame: first 7 days post-randomization
  description: The severity of delirium will be measured during daily screening using standardized algorithms for extracting symptom severity from the 3D-CAM and CAM-ICU.
  measure: Number of Patients who experience Acute kidney injury (AKI)
  time frame: within -7 days post-randomization
  description: Number of Patients who experience Acute kidney injury will be assessed within 7 days post-randomization.
  measure: All-cause mortality
  time frame: within 90 days post-randomization
  description: All-cause mortality within 90 days post-randomization will be assessed.
  measure: All-cause mortality
  time frame: within 12 months post-randomization
  description: All-cause mortality within 12-months post-randomization will be assessed.
  measure: Length of Index Hospitalization
  time frame: at hospital discharge, up to 30 days
  description: Overall length of stay for the index hospitalization post-randomization will be measured and broken down by days spent in the ICU versus days not in the ICU.
  measure: Discharge disposition
  time frame: at hospital discharge, up to 30 days
  description: Discharge disposition
  measure: Readmissions rates
  time frame: first 90 days
  description: Readmission rates will be calculated for the first 90 days following randomization. Hospitalizations will be classified for all causes including for cardiovascular readmissions.
  measure: Readmissions rates
  time frame: up to 1 year post-randomization
  description: Readmission rates will be calculated for the duration of follow-up, out to 1 year. Hospitalizations will be classified for all causes including for cardiovascular readmissions.
  measure: Days Alive out of Hospital
  time frame: within 90 days post-randomization
  description: Days alive out of hospital and nursing/rehab facilities within 90 days after randomization
  arm group label: CardioGard Embolic Protection Cannula
  arm group type: Active Comparator
  description: In patients assigned to the embolic protection device group, the CardioGard Embolic Protection Cannula is used instead, according to the manufacturer's instructions for use (IFU).
  arm group label: Standard Aortic Cannula
  arm group type: Placebo Comparator
  description: In patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice
  intervention type: Device
  intervention name: CardioGard Embolic Protection Cannula
  description: The CardioGard embolic protection cannula is a device that combines the function of a standard aortic cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The device is comprised of 2 hollow tubes. The first tube is the standard main forward-flow tube to return oxygenated blood to the patient's aorta. The second tube attached to an existing bypass vent port, is a novel element located posteriorly to the main tube; its function is to facilitate blood and particle suction by directing the blood back to the reservoir of the coronary bypass machine, while the retrieved embolic debris is eliminated through the filter of the venous reservoir.
  arm group label: CardioGard Embolic Protection Cannula
  intervention type: Device
  intervention name: Standard Aortic Cannula
  description: An aortic cannula is a device that is used routinely during cardiac surgery to return oxygenated blood from the cardiac bypass machine into the patient's aorta.
  arm group label: Standard Aortic Cannula
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Annetine C. Gelijns, PhD
  role: Principal Investigator
  affiliation: Icahn School of Medicine at Mount Sinai
  last name: Ellen Moquete
  phone: 212-659-9651
  email: ellen.moquete@mountsinai.org
  last name: Claudia Merlin
  phone: 917-494-2387
  email: Claudia.merlin@mountsinai.org
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  country: Canada
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Icahn School of Medicine at Mount Sinai
  investigator full name: Annetine Gelijns
  investigator title: Professor of Health Policy, Chair Department of Health Evidence & Policy
  mesh term: Ischemic Stroke
  mesh term: Acute Kidney Injury
  sharing ipd: Yes
  ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: De-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.
  ipd access criteria: Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link to be included in the URL field below).
  ipd url: https://biolincc.nhlbi.nih.gov/studies/