This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 interventi…
What they're measuring
1
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
Timeframe: within 3 days post-randomization
2
Number of patients who experience of death and delirium