CTSN Embolic Protection Trial

Prior treatment

• History of clinical stroke within 3 months prior to randomization
• 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
• Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
• Participation in an interventional (drug or device) trial
• 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

Other

• Cerebral and or aortic arch arteriography or interventions within 3 days of the planned procedure
• Active endocarditis at time of randomization with vegetation criteria
• Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair

• 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