Status:
RECRUITING
CTSN Embolic Protection Trial
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Delirium
Ischemic Stroke
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
Detailed Description
This is a prospective, multicenter, randomized controlled clinical trial that will evaluate the effectiveness and safety of the CardioGard embolic protection cannula compared to a standard cannula. Th...
Eligibility Criteria
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,
- 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
- 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
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
842 Patients enrolled
Trial Details
Trial ID
NCT06027788
Start Date
September 18 2023
End Date
April 1 2027
Last Update
July 20 2025
Active Locations (28)
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1
CHI St. Vincent Heart Institute
North Little Rock, Arkansas, United States, 72117
2
Keck Hospital of the University of Southern California
Los Angeles, California, United States, 90033
3
Emory University
Atlanta, Georgia, United States, 30322
4
Indiana University
Bloomington, Indiana, United States, 47405