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CTSN Embolic Protection Trial
Sponsor: Icahn School of Medicine at Mount Sinai
Summary
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
Official title: Embolic Protection in Patients Undergoing High-Risk Valve Surgery
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
842
Start Date
2023-09-18
Completion Date
2027-04-01
Last Updated
2025-07-20
Healthy Volunteers
No
Interventions
CardioGard Embolic Protection Cannula
The CardioGard embolic protection cannula is a device that combines the function of a standard aortic cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The device is comprised of 2 hollow tubes. The first tube is the standard main forward-flow tube to return oxygenated blood to the patient's aorta. The second tube attached to an existing bypass vent port, is a novel element located posteriorly to the main tube; its function is to facilitate blood and particle suction by directing the blood back to the reservoir of the coronary bypass machine, while the retrieved embolic debris is eliminated through the filter of the venous reservoir.
Standard Aortic Cannula
An aortic cannula is a device that is used routinely during cardiac surgery to return oxygenated blood from the cardiac bypass machine into the patient's aorta.
Locations (28)
CHI St. Vincent Heart Institute
North Little Rock, Arkansas, United States
Keck Hospital of the University of Southern California
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Bloomington, Indiana, United States
Indiana Ohio Heart
Fort Wayne, Indiana, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Johns Hopkins Medicine
Baltimore, Maryland, United States
University of Maryland
College Park, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Columbia University Medical Center
New York, New York, United States
New York Presbyterian-Cornell Medical Center
New York, New York, United States
NYU Langone Hospital Brooklyn
New York, New York, United States
Northwell Health
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
University Hospitals
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
London Health Sciences Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Hôpital Laval
Québec, Quebec, Canada