CTSN Embolic Protection Trial

NARecruitingINTERVENTIONAL
Enrollment

842

Participants

Timeline

Start Date

September 18, 2023

Primary Completion Date

April 1, 2027

Study Completion Date

April 1, 2027

Conditions
DeliriumIschemic StrokeAcute Kidney InjuryHeart Valve DiseaseCoronary Artery Disease
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.

Trial Locations (28)

10032

RECRUITING

Columbia University Medical Center, New York

10065

NOT_YET_RECRUITING

New York Presbyterian-Cornell Medical Center, New York

10467

RECRUITING

Montefiore Medical Center, The Bronx

11220

RECRUITING

NYU Langone Hospital Brooklyn, New York

19104

RECRUITING

Hospital of the University of Pennsylvania, Philadelphia

20742

RECRUITING

University of Maryland, College Park

21287

RECRUITING

Johns Hopkins Medicine, Baltimore

RECRUITING

Northwell Health, New York

22903

NOT_YET_RECRUITING

University of Virginia, Charlottesville

26506

RECRUITING

West Virginia University, Morgantown

27710

RECRUITING

Duke University, Durham

30322

RECRUITING

Emory University, Atlanta

44106

NOT_YET_RECRUITING

University Hospitals, Cleveland

44195

RECRUITING

Cleveland Clinic, Cleveland

46804

RECRUITING

Indiana Ohio Heart, Fort Wayne

47405

NOT_YET_RECRUITING

Indiana University, Bloomington

48109

RECRUITING

University of Michigan, Ann Arbor

55905

RECRUITING

Mayo Clinic, Rochester

64111

RECRUITING

Saint Luke's Hospital of Kansas City, Kansas City

70506

RECRUITING

Ochsner Clinic, New Orleans

72117

RECRUITING

CHI St. Vincent Heart Institute, North Little Rock

90033

RECRUITING

Keck Hospital of the University of Southern California, Los Angeles

04102

RECRUITING

Maine Medical Center, Portland

02114

RECRUITING

Massachusetts General Hospital, Boston

Unknown

NOT_YET_RECRUITING

London Health Sciences Centre, London

NOT_YET_RECRUITING

University of Ottawa Heart Institute, Ottawa

NOT_YET_RECRUITING

Montreal Heart Institute, Montreal

QC G1V 4G5

NOT_YET_RECRUITING

Hôpital Laval, Québec

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Icahn School of Medicine at Mount Sinai

OTHER