| NCT ID | NCT06027788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 842 participants |
| Start Date | 2023-09-18 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 842 participants in total. It began in 2023-09-18 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
Eligibility Criteria
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
Contact & Investigator
Annetine C. Gelijns, PhD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06027788 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06027788 currently recruiting?
Yes, NCT06027788 is actively recruiting participants. Contact the research team at Claudia.merlin@mountsinai.org for enrollment information.
Where is the NCT06027788 trial being conducted?
This trial is being conducted at North Little Rock, United States, Los Angeles, United States, Atlanta, United States, Bloomington, United States and 11 additional locations.
Who is sponsoring the NCT06027788 clinical trial?
NCT06027788 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Annetine C. Gelijns, PhD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 842 participants.