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Neuroprotection In Patients Undergoing Aortic Valve Replacement

Description

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.

Phase

N/A

Inclusion and Exclusion 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

  • 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

Sites

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