Testing CardioGard Embolic Protection Cannula with Standard Aortic Cannula against a placebo for delirium
Official title: CTSN Embolic Protection Trial
Embolic Protection in Patients Undergoing High-Risk Valve Surgery
- 2 groups
- Sites in London, Ottawa and 2 more cities
- Recruiting
Interventions
- Medical device
CardioGard Embolic Protection Cannula
The 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.
- Medical device
Standard Aortic Cannula
An 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.
Canadian Sites (4)
2 of 4 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
- Not yet recruiting
Montreal Heart Institute
Montreal, Quebec
- Not yet recruiting
Hôpital Laval
Québec, Quebec
Eligibility Criteria
See who this study is looking for19 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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,
- +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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- +Ability to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and comply with the protocolProtocolThe detailed plan a study must follow.Read more →
- +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.
Exclusion
- −History of clinical stroke within 3 months prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →/baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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 interventionalInterventional studyA study where participants are given something to see what happens.Read more → (drug or device) trial
- −Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair
- −Planned concomitant carotid endarterectomy during index surgical procedure
- −Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives CardioGard Embolic Protection Cannula.
Registry label: A: CardioGard Embolic Protection Cannula
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Standard Aortic Cannula.
Registry label: B: Standard Aortic Cannula
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 60 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 842 people.
The study is currently expected to finish around April 2027.
The main measurement is taken over: within 3 days post-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI) — measured over within 3 days post-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
Number of patients who experience of death and delirium — measured over by 7 days post-randomization.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06027788 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About CardioGard Embolic Protection CannulaDevice
The 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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Standard Aortic CannulaDevice
An 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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 60 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 60 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: within 3 days post-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
The study as a whole is currently expected to finish around 2027-04-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 842 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 8 locations, including: London, Ontario, Canada; Ottawa, Ontario, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada; Ann Arbor, Michigan, United States; Rochester, Minnesota, United States, and 2 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
Other Sites (7)
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
New York Presbyterian-Cornell Medical Center
New York, New York, United States
NYU Langone Hospital Brooklyn
New York, New York, United States
Northwell Health
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.