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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CardioGard Embolic Protection Cannula
DeviceThe CardioGard embolic protection cannula is a device that combines the function of a standard aortic cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The device is comprised of 2 hollow tubes. The first tube is the standard main forward-flow tube to return oxygenated blood to the patient's aorta. The second tube attached to an existing bypass vent port, is a novel element located posteriorly to the main tube; its function is to facilitate blood and particle suction by directing the blood back to the reservoir of the coronary bypass machine, while the retrieved embolic debris is eliminated through the filter of the venous reservoir.
Standard Aortic Cannula
DeviceAn aortic cannula is a device that is used routinely during cardiac surgery to return oxygenated blood from the cardiac bypass machine into the patient's aorta.
Treatment groups
842 Participants
are divided into 2 treatment groupsGroup A: CardioGard Embolic Protection CannulaActive comparator 1 intervention
Group B: Standard Aortic CannulaPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
The combined number of patients who experience clinical ischemic strokes and acute kidney injuries that have occurred within 3 days post-randomization.
Time frame
within 3 days post-randomization2
Number of patients who experience of death and delirium
The combined number of patients who experience death and delirium by 7 days post-randomization (with a blanking period for delirium of days 1 and 2 post-operatively).
Time frame
by 7 days post-randomizationSecondary outcomes
1
Proportion of patients who experience a clinical ischemic stroke
The proportion of patients who experience a clinical ischemic stroke within 3 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
Time frame
within 3 days post-randomization2
Proportion of patients who experience a clinical ischemic stroke
The proportion of patients who experience a clinical ischemic stroke within 7 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
Time frame
within 7 days post-randomization3
Number of patients with disabling clinical stroke
Number of patients with disabling clinical stroke within 3 days post-randomization
Time frame
within 3 days post-randomization4
Number of patients with disabling clinical stroke
Number of patients with disabling clinical stroke within 7 days post-randomization
Time frame
within 7 days post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov