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RECRUITING
NCT06027788
NA

CTSN Embolic Protection Trial

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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