CTSN Embolic Protection Trial
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
| Condition(s) | Delirium, Ischemic Stroke, Acute Kidney Injury, Heart Valve Disease, Coronary Artery Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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 prio |
| Ages | 60 Years |
| Sex | All |
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
| Locations | 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 (+22 more sites) |
| Start date | 2023-09-18 |
| NCT ID | NCT06027788 |
| Official listing | https://clinicaltrials.gov/study/NCT06027788 |