Neuroprotection In Patients Undergoing Aortic Valve Replacement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 383
- Locations
- 35
- Primary Endpoint
- Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction
Study Overview
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).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Embol-X Embolic Protection Device (Device)
CardioGard Cannula
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
Intervention: CardioGard Cannula (Device)
Standard Cannula
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Outcomes
Primary Outcomes
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
- Total Infarct Volume(Day 7)
- Decline in Overall Neurocognition(baseline and 90 days)
- Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury(up to 30 days)
- Number of Patients With Clinically Apparent Stroke at 7 Days(at 7 days)
- Presence of Radiographic Infarcts(up to 10 days)
- Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days(baseline and 90 days)
- Quality of Life - Physical Health Composite(at 90 days)
- Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days(baseline and 90 days)
- Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days(baseline and 90 days)
- Decline in Neurocognitive Function in the Executive Function Domain at 90 Day(baseline and 90 days)
- Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days(baseline and 90 days)
- Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days(baseline and 90 days)
- Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days(7 days)
- Modified Rankin Scale >2 at 90 Days(90 days)
- Quality of Life - Mental Health Composite(at 90 days)
- Barthel Index <= 80(90 days)
- Hospital Readmissions(up to 90 days)
- Mortality by 90 Days(up to 90 days)
- Length of Stay for Index Hospitalization(up to 90 days)
- Number of Participants With Emboli Captured(day 1)
Investigators
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