Neuroprotection in Patients Undergoing Aortic Valve Replacement

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Embol-X Embolic Protection Device Device
    Other Names: Edwards Embol-X embolic protection device
    Intervention Desc: per the manufacturer's instructions for use (IFU).
    ARM 1: Kind: Experimental
    Label: Embol-X Embolic Protection Device
    Description: use (IFU), during their surgery.
  • CardioGard Cannula Device
    Other Names: CardioGard Emboli Protection Cannula
    Intervention Desc: CardioGard Cannula, per the manufacturer's instructions for use (IFU).
    ARM 1: Kind: Experimental
    Label: CardioGard Cannula
    Description: The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary freedom from clinical or radiographic CNS infarction up to 10 days post procedure Yes
Secondary A composite endpoint of mortality, clinical stroke, and acute kidney injury up to 30 days Yes
Secondary Clinical and Radiographic Brain Injury up to 90 days Yes
Secondary Safety of study device, as measured by Incidence of serious or protocol defined adverse events. up to 90 days Yes
Secondary Emboli Volume Day 1 No
Secondary Change in Hopkins Verbal Learning Test baseline and 90 days No
Secondary Change in Trailmaking Tests A and B baseline and 90 days No
Secondary Change in MCG Complex Figures baseline and 90 days No
Secondary Change in Digit Span baseline and 90 days No
Secondary Change in Digit Substitution Test baseline and 90 days No
Secondary Change in COWA Verbal Fluency Test baseline and 90 days No
Secondary Change in NIH Stroke Scale baseline and 90 days No
Secondary Change in Modified Rankin Scale baseline and 90 days No
Secondary Change in Barthel Index baseline and 90 days No
Secondary Change in confusion Assessment Method (CAM) Delirium Assessment baseline and 90 days No
Secondary Survival up to 90 days No
Secondary Length of Stay hospitalization up to 90 days No
Secondary Hospital Readmissions up to 90 days No
Secondary Mortality up to 90 days No
Secondary Quality of life up to 90 days No
Secondary Device Performance day 1 No
Primary freedom from clinical or radiographic central nervous system (CNS) infarction up to 10 days post procedure Yes

Sponsors