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New treatment option for Delirium
Official title CTSN Embolic Protection Trial
ClinicalTrials.gov ID: NCT06027788
What this study is testing
- What it's testing
- This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
- Time commitment: about 30 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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,
You likely can't join if
- 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...
- 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 treatment (drug or device) trial
See the full eligibility 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...
- 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
- 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 treatment (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
The study team makes the final eligibility decision.
Where it's taking place
- North Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Atlanta, Georgia, United States
- Bloomington, Indiana, United States
- Fort Wayne, Indiana, United States
- New Orleans, Louisiana, United States
- Portland, Maine, United States
- Baltimore, Maryland, United States
- College Park, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Charlottesville, Virginia, United States
- Morgantown, West Virginia, United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 30 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include North Little Rock, Arkansas, United States; Los Angeles, California, United States; Atlanta, Georgia, United States; Bloomington, Indiana, United States; Fort Wayne, Indiana, United States; New Orleans, Louisiana, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.