CTSN Embolic Protection Trial

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Aug 31, 2023

Keywords

ClinConnect Summary

The CTSN Embolic Protection Trial is studying the CardioGard Embolic Protection Cannula, a device designed to help protect patients from potential complications during high-risk heart valve surgeries. This trial is looking for participants who are at least 60 years old and are scheduled for specific surgeries, such as aortic or mitral valve replacement, or other heart procedures. To be eligible, participants should have no serious neurological issues and must be able to understand and agree to take part in the trial.

If you join the trial, you will be randomly assigned to either receive the CardioGard device or standard care during your surgery. The goal is to see if the device can help prevent complications like stroke and kidney injury during and after surgery. This trial is currently recruiting participants of all genders, and it's important to note that certain medical conditions may disqualify someone from participating, such as a recent stroke or infection in the heart. Overall, the trial aims to improve outcomes for patients undergoing these types of heart surgeries.

Gender

ALL

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