CTSN Embolic Protection Trial

Recruiting now · Not applicable

Conditions studied: Delirium, Ischemic Stroke, Acute Kidney Injury, Heart Valve Disease, Coronary Artery Disease

In brief

This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.

Key facts

Study ID

NCT06027788

Run by

Icahn School of Medicine at Mount Sinai

People needed

842

Starts

2023-09-18

Expected to finish

2027-04-01

Last updated by the study team

2026-05-29

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Maine Medical Center — Portland, Maine, United States (enrolling)
• West Virginia University — Morgantown, West Virginia, United States (enrolling)
• London Health Sciences Centre — London, Ontario, Canada (enrolling)
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (enrolling)
• Johns Hopkins Medicine — Baltimore, Maryland, United States (enrolling)
• CHI St. Vincent Heart Institute — North Little Rock, Arkansas, United States (enrolling)
• University of Maryland — College Park, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Keck Hospital of the University of Southern California — Los Angeles, California, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Northwell Health — New York, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Ochsner Clinic — New Orleans, Louisiana, United States (enrolling)
• Hôpital Laval — Québec, Quebec, Canada
• Indiana University — Bloomington, Indiana, United States
• Indiana Ohio Heart — Fort Wayne, Indiana, United States
• New York Presbyterian-Cornell Medical Center — New York, New York, United States
• NYU Langone Hospital Brooklyn — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.