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Neuroprotection in Patients Undergoing Aortic Valve Replacement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02389894
First Posted: March 17, 2015
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Annetine Gelijns, Icahn School of Medicine at Mount Sinai
  Purpose
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).

Condition Intervention
Aortic Stenosis Brain Infarction Cerebrovascular Accident Stroke Device: Embol-X Embolic Protection Device Device: CardioGard Cannula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Neuroprotection In Patients Undergoing Aortic Valve Replacement

Resource links provided by NLM:


Further study details as provided by Annetine Gelijns, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • 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:
  • A composite endpoint of mortality, clinical stroke, and acute kidney injury [ Time Frame: up to 30 days ]
    The proportion of patients who have had a clinical ischemic stroke, acute kidney injury (AKI), or death within 30 days of surgery.

  • Clinical and Radiographic Brain Injury [ Time Frame: up to 90 days ]
    The proportion of patients who experience a non-silent stroke. The volume and number of brain lesions will be measured using 1.5 T DWI (3.0 T is acceptable if 1.5 T not available).

  • Safety of study device, as measured by Incidence of serious or protocol defined adverse events. [ Time Frame: up to 90 days ]
    Incidence of serious or protocol defined adverse events.

  • Emboli Volume [ Time Frame: Day 1 ]
    Volume of the emboli captured by the Embol-X filter will be processed using electron microscopy (EM)

  • Change in Hopkins Verbal Learning Test [ Time Frame: baseline and 90 days ]
    Change in neurocognitive function at 90 days as compared to baseline

  • Change in Trailmaking Tests A and B [ Time Frame: baseline and 90 days ]
    Change in neurocognitive function at 90 days as compared to baseline

  • Change in MCG Complex Figures [ Time Frame: baseline and 90 days ]
    Change in neurocognitive function at 90 days as compared to baseline

  • Change in Digit Span [ Time Frame: baseline and 90 days ]
    Change in neurocognitive function at 90 days as compared to baseline

  • Change in Digit Substitution Test [ Time Frame: baseline and 90 days ]
    Change in neurocognitive function at 90 days as compared to baseline

  • Change in COWA Verbal Fluency Test [ Time Frame: baseline and 90 days ]
    Change in neurocognitive function at 90 days as compared to baseline

  • Change in NIH Stroke Scale [ Time Frame: baseline and 90 days ]
    Neurological outcomes assessed at 90 days as compared to baseline

  • Change in Modified Rankin Scale [ Time Frame: baseline and 90 days ]
    Neurological outcomes assessed at 90 days as compared to baseline

  • Change in Barthel Index [ Time Frame: baseline and 90 days ]
    Neurological outcomes assessed at 90 days as compared to baseline

  • Change in confusion Assessment Method (CAM) Delirium Assessment [ Time Frame: baseline and 90 days ]
    Delirium assessed at 90 days as compared to baseline

  • Survival [ Time Frame: up to 90 days ]
    Incidence of all-cause mortality

  • Length of Stay hospitalization [ Time Frame: up to 90 days ]
  • Hospital Readmissions [ Time Frame: up to 90 days ]
    Incidence of hospital readmissions

  • Mortality [ Time Frame: up to 90 days ]
    Number of days alive out of the hospital

  • Quality of life [ Time Frame: up to 90 days ]
    Assessed by Short Form-12 (SF-12) and Geriatric Depression Scale (GDS) composite

  • Device Performance [ Time Frame: day 1 ]
    Assessed by need for additional surgery or re-intervention related to use of the embolic protection device


Enrollment: 383
Study Start Date: March 2015
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
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
Principal Investigator: Annetine C Gelijns, PhD Icahn School of Medicine at Mount Sinai
Study Chair: Richard Weisel, MD Toronto General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Submitted: March 10, 2015
First Posted: March 17, 2015
Last Update Posted: April 13, 2017
Last Verified: April 2017

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:
Infarction
Aortic Valve Stenosis
Stroke
Brain Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Ischemia