United States, Canada842 participantsStarted 2023-09-18
Plain-language summary
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 interventi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically looking at ischemic stroke, acute kidney injury, delirium, and death as its main outcomes — given my diagnosis involving heart valve disease or coronary artery disease, how likely am I to face those particular risks during my procedure, and could joining this trial change how those risks are managed?
2The trial is listed as 'Phase NA,' which often means it's a device or surgical study rather than a drug trial — can you explain what exactly is being tested here, whether it involves an embolic protection device during my heart procedure, and what that would mean for how my surgery is performed?
3Since the trial is actively recruiting, what would actually be different about my care if I enrolled compared to the standard treatment I'd receive outside the trial, and is there any chance I'd be in a group that doesn't receive the embolic protection being studied?
4Delirium and acute kidney injury are listed as outcomes being tracked — are these complications I'm already at risk for based on my current condition, and would you recommend I consider this trial as a way to potentially reduce that risk, or is standard care just as protective?
5What are the practical demands of joining this trial — things like extra hospital visits, additional monitoring, or follow-up testing — and given my overall health situation, do you think the logistical burden is manageable or would pursuing standard treatment be a more straightforward path for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
Timeframe: within 3 days post-randomization
2
Number of patients who experience of death and delirium