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CTSN Embolic Protection Trial

Sponsored by Icahn School of Medicine at Mount Sinai

About this study

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

This is a prospective, multicenter, randomized controlled clinical trial that will evaluate the effectiveness and safety of the CardioGard embolic protection cannula compared to a standard cannula. The enrollment period is expected to last 30 months, and all patients will be followed for 12 months post procedure. RANDOMIZATION Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the operating room (OR) immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device). Randomization will be with equal allocation and stratified by site and by procedure (i.e., isolated valve surgery or combined procedures, such as double valve or valve plus coronary arter…

Where this study is enrolling (19)

Show all 19 locations
Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.