Health Trials

About this trial

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

Eligibility criteria

Qualifiers

Age ≥ 60 years

Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory arrest is not required) ± CABG

Mitral valve replacement (MVR) ± CABG

Mitral Valve Repair + CABG,

Disqualifiers

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

Trial design

Treatments tested in this trial

  • CardioGard Embolic Protection Cannula
  • Standard Aortic Cannula

Treatment groups

842 Participants
are divided into 2 treatment groups

Locations

28
Canada
London Health Sciences Centre LondonOntario, Canada
University of Ottawa Heart Institute OttawaOntario, Canada
Montreal Heart Institute MontrealQuebec, Canada
Hôpital LavalQC G1V 4G5, QuébecQuebec, Canada

Sponsors and collaborators

Icahn School of Medicine at Mount Sinai

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov