Neuroprotection in Patients Undergoing Aortic Valve Replacement

Completed

Phase N/A Results N/A

Eligibility 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