CardioGard for High-Risk Heart Valve Surgery

Inclusion Criteria: * Age ≥ 60 years * Planned de novo or redo: * Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory arrest is not required) ± CABG * Mitral valve replacement (MVR) ± CABG * Mitral Valve Repair + CABG, * Double/Triple valve surgery ± CABG; Ross procedure These procedures can be done via a full or minimal-access sternotomy (using central aortic perfusion cannulae) with legally marketed valve(s), and can be done in combination with an left atrial appendage (LAA) closure/excision or partial/complete Maze procedure. * Valve sparing aortic root replacement (David procedure) * Valve sparing aortic root replacement (David procedure) * No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 30 days prior to randomization * Ability to provide informed consent and comply with the protocol Exclusion Criteria: * History of clinical stroke within 3 months prior to randomization * Cerebral and or aortic arch arteriography or interventions within 3 days of the planned procedure * Coronary catheterization within 3 days of index procedure, and the required repeat NIHSS score post-catheterization is worse than the screening/baseline NIHSS score conducted prior to the catheterization * Active endocarditis at time of randomization with vegetation criteria * Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization * Participation in an interventional (drug or device) trial * Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair * Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigator * Planned concomitant carotid endarterectomy during index surgical procedure