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Trial record 1 of 1 for:    NCT02389894
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Neuroprotection in Patients Undergoing Aortic Valve Replacement

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ClinicalTrials.gov Identifier: NCT02389894
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Annetine Gelijns, Icahn School of Medicine at Mount Sinai

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

Condition or disease Intervention/treatment Phase
Aortic Stenosis Brain Infarction Cerebrovascular Accident Stroke Device: Embol-X Embolic Protection Device Device: CardioGard Cannula Not Applicable

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

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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Embol-X Embolic Protection Device
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
Device: Embol-X Embolic Protection Device
per the manufacturer's instructions for use (IFU).
Other Name: Edwards Embol-X embolic protection device

Active Comparator: CardioGard Cannula
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
Device: CardioGard Cannula
CardioGard Cannula, per the manufacturer's instructions for use (IFU).
Other Name: CardioGard Emboli Protection Cannula

No Intervention: Standard Cannula
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.



Primary Outcome Measures :
  1. Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction [ Time Frame: up to 10 days post procedure ]
    freedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting > 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any present lesions.


Secondary Outcome Measures :
  1. Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury [ Time Frame: up to 30 days ]
    The number of patients who have had a clinical ischemic stroke, acute kidney injury (AKI), or death within 30 days of surgery.

  2. Number of Patients With Clinically Apparent Stroke at 7 Days [ Time Frame: at 7 days ]
    The number of patients who experience a clinically apparent stroke by 7 days post-op

  3. Presence of Radiographic Infarcts [ Time Frame: up to 10 days ]
    The proportion of patients with radiographic infarcts on day 7 (+/-3 days) MRI. Presences of radiographic infarcts were measured using diffusion-weighted 1.5 or 3T MRI scanners

  4. Total Infarct Volume [ Time Frame: Day 7 ]
    Total infarct volume measured on day 7 dwMRI.

  5. Decline in Overall Neurocognition [ Time Frame: baseline and 90 days ]
    Decline in neurocognitive function at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.

  6. Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days [ Time Frame: baseline and 90 days ]
    Decline in neurocognitive function in the verbal memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.

  7. Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days [ Time Frame: baseline and 90 days ]
    Decline in neurocognitive function in the visual memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.

  8. Decline in Neurocognitive Function in the Executive Function Domain at 90 Day [ Time Frame: baseline and 90 days ]
    Decline in neurocognitive function in the executive function domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.

  9. Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days [ Time Frame: baseline and 90 days ]
    Decline in neurocognitive function in the visuospatial/constructional praxis domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.

  10. Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days [ Time Frame: baseline and 90 days ]
    Decline in neurocognitive function in the Auditory-Verbal Simple attention domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.

  11. Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days [ Time Frame: baseline and 90 days ]
    Decline in neurocognitive function in the Visuomotor/Information Processing Speed domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.

  12. Modified Rankin Scale >2 at 90 Days [ Time Frame: 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.

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

  14. Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days [ Time Frame: 7 days ]
  15. Mortality by 90 Days [ Time Frame: up to 90 days ]
    Incidence of all-cause mortality

  16. Length of Stay for Index Hospitalization [ Time Frame: up to 90 days ]
  17. Hospital Readmissions [ Time Frame: up to 90 days ]
    Rate of hospital readmissions

  18. Quality of Life - Physical Health Composite [ Time Frame: at 90 days ]
    Quality of Life - Physical Health Composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10.

  19. Quality of Life - Mental Health Composite [ Time Frame: at 90 days ]
    Quality of life - Mental health composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10.

  20. Number of Participants With Emboli Captured [ Time Frame: day 1 ]
    Assessed by the presence of any debris captured in filter of embolic protection device



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 60 years
  • Planned and scheduled surgical aortic valve replacement via a full or minimal-access sternotomy (using central aortic perfusion cannulae) for calcific aortic stenosis with a legally marketed valve
  • No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization
  • Ability to provide informed consent and comply with the protocol

Exclusion Criteria:

  • Contraindication to legally marketed embolic protection devices (e.g. aneurysm of the ascending aorta, aortic trauma, porcelain aorta, known sensitivity to heparin)
  • History of clinical stroke within 3 months prior to randomization
  • Cardiac catheterization within 3 days of the planned aortic valve replacement
  • Cerebral and or aortic arch arteriography or interventions within 3 days of the planned aortic valve replacement
  • Active endocarditis at time of randomization
  • Anticipated inability to tolerate or contraindication for MRI (e.g., known intolerance of MRI, permanent pacemaker at baseline or expected implantation of a permanent pacemaker)
  • Any other concomitant aortic procedure such as root replacement
  • Concomitant surgical procedures other than CABG, mitral annuloplasty, left atrial appendage (LAA) excision or exclusion, atrial septal defect (ASD) closure or patent foramen ovale (PFO) closure
  • Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
  • Concurrent participation in an interventional (drug or device) trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389894


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, United States, 20814
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
United States, New York
Montefiore Einstein Heart Center
Bronx, New York, United States, 10467
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Mission Hospital
Asheville, North Carolina, United States, 28801
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor Research Institute
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G2B7
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Canada
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Annetine C Gelijns, PhD Icahn School of Medicine at Mount Sinai
Study Chair: Richard Weisel, MD Toronto General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Annetine Gelijns, Chair, Department of Population Health Science & Policy, Edmond A. Guggenheim Professor of Health Policy Co-Director, InCHOIR, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02389894     History of Changes
Other Study ID Numbers: GCO 08-1078-0009
2U01HL088942-07 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2015    Key Record Dates
Results First Posted: April 29, 2019
Last Update Posted: April 29, 2019
Last Verified: April 2019
Keywords provided by Annetine Gelijns, Icahn School of Medicine at Mount Sinai:
Embolic Protection Device
Stroke
Brain Infarction
atheroma
Aortic Valve Replacement
Additional relevant MeSH terms:
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Stroke
Brain Infarction
Aortic Valve Stenosis
Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction
Brain Ischemia