RecruitingDeliriumIschemic StrokeAcute Kidney Injury

CTSN Embolic Protection Trial

Eligible age

60+ yrs

Accepts

All genders

Locations

17 states

Healthy volunteers

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This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.

Sponsor: Icahn School of Medicine at Mount Sinai

✓ 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)

✕ 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