CTSN Embolic Protection Trial

Not Applicable

Recruiting

• Conditions: Delirium; Ischemic Stroke; Acute Kidney Injury; Heart Valve Disease; Coronary Artery Disease

• Registration Number: NCT06027788
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-8-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 842

Inclusion Criteria

Inclusion Criteria:<br><br> - Age = 60 years<br><br> - Planned de novo or redo:<br><br> - Surgical aortic valve replacement SAVR ± ascending aortic repair (if<br> circulatory arrest is not required) ± CABG<br><br> - Mitral valve replacement (MVR) ± CABG<br><br> - Mitral Valve Repair + CABG,<br><br> - Double/Triple valve surgery ± CABG; Ross procedure These procedures can be done<br> via a full or minimal-access sternotomy (using central aortic perfusion<br> cannulae) with legally marketed valve(s), and can be done in combination with<br> an left atrial appendage (LAA) closure/excision or partial/complete Maze<br> procedure.<br><br> - No evidence of neurological impairment as defined by a NIHSS =1 and modified Rankin<br> scale (mRS) =2 within 7 days prior to randomization<br><br> - Ability to provide informed consent and comply with the protocol Exclusion Criteria<br><br>Exclusion Criteria:<br><br> - History of clinical stroke within 3 months prior to randomization<br><br> - Cerebral and or aortic arch arteriography or interventions within 3 days of the<br> planned procedure<br><br> - Coronary catheterization within 3 days of the planned procedure<br><br> - Active endocarditis at time of randomization with vegetation criteria<br><br> - Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to<br> randomization<br><br> - Participation in an interventional (drug or device) trial<br><br> - Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral<br> valve repair and tricuspid valve repair<br><br> - Anticipated requirement for prolonged mechanical ventilation greater than 48 hours<br> after surgery in the opinion of the investigator

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI);Number of patients who experience of death and delirium