CTSN Embolic Protection Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorIcahn School of Medicine at Mount Sinai
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 groupsSponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov