NCT06027788 · Icahn School of Medicine at Mount Sinai
CTSN Embolic Protection Trial
(EMPRO)
What this study is about
This is a forward-looking, multi-center, randomly assigned effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
View original scientific description
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 interventional (drug or device) trial
- Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair
- Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigator
- Planned concomitant carotid endarterectomy during index surgical procedure
Where
- North Little Rock, Arkansas
- Los Angeles, California
- Atlanta, Georgia
- Bloomington, Indiana
- Fort Wayne, Indiana
- New Orleans, Louisiana
- Portland, Maine
- Baltimore, Maryland
- College Park, Maryland
- Boston, Massachusetts
- Ann Arbor, Michigan
- Rochester, Minnesota
And 8 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 29, 2026 · Source of record for eligibility and locations