CTSN Embolic Protection Trial

Summary

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

Eligibility

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

Conditions6

Locations24 sites

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