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Completed

NCT Number: NCT02389894

Neuroprotection in Patients Undergoing Aortic Valve Replacement

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

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Heart Diseases Heart Valve Diseases Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Atherosclerotic Stroke Vascular Diseases Ventricular Outflow Obstruction

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Embol-X Embolic Protection Device

Device

per the manufacturer's instructions for use (IFU).

Other names: Edwards Embol-X embolic protection device

CardioGard Cannula

Device

CardioGard Cannula, per the manufacturer's instructions for use (IFU).

Other names: CardioGard Emboli Protection Cannula

Primary outcomes

  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 outcomes

  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.

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

  13. Barthel Index <= 80

    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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2015
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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