New device aims to catch surgical debris, prevent stroke and kidney damage

NCT ID NCT06027788

Recruiting now Disease control Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests a special cannula that captures debris during high-risk heart valve surgery. The goal is to see if it reduces the chance of stroke, kidney injury, and delirium. About 842 patients aged 60 and older will be randomly assigned to receive either the new device or a standard cannula.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: CardioGard Embolic Protection Cannula (a device that combines a standard aortic cannula with a suction mechanism to capture debris during heart surgery)
What this could lead to: If it works, this device could reduce serious complications like stroke, kidney injury, and delirium after high-risk heart valve surgery.
What could go wrong: This is a relatively early-stage trial, and the device may not significantly reduce complications. There is also a risk that the suction mechanism could cause other issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

acute kidney injury coronary artery disorder delirium heart valve disorder ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE KIDNEY INJURY CORONARY ARTERY DISEASE DELIRIUM HEART VALVE DISEASE ISCHEMIC STROKE

Contacts and locations

Locations

CHI St. Vincent Heart Institute
RECRUITING

North Little Rock, Arkansas, 72117, United States
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Columbia University Medical Center
RECRUITING

New York, New York, 10032, United States
Duke University
RECRUITING

Durham, North Carolina, 27710, United States
Emory University
RECRUITING

Atlanta, Georgia, 30322, United States
Hospital of the University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Hôpital Laval
NOT_YET_RECRUITING

Québec, Quebec, QC G1V 4G5, Canada
Indiana Ohio Heart
WITHDRAWN

Fort Wayne, Indiana, 46804, United States
Indiana University
WITHDRAWN

Bloomington, Indiana, 47405, United States
Johns Hopkins Medicine
RECRUITING

Baltimore, Maryland, 21287, United States
Keck Hospital of the University of Southern California
RECRUITING

Los Angeles, California, 90033, United States
London Health Sciences Centre
RECRUITING

London, Ontario, Canada
Maine Medical Center
RECRUITING

Portland, Maine, 04102, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10467, United States
Montreal Heart Institute
NOT_YET_RECRUITING

Montreal, Quebec, Canada
NYU Langone Hospital Brooklyn
WITHDRAWN

New York, New York, 11220, United States
New York Presbyterian-Cornell Medical Center
WITHDRAWN

New York, New York, 10065, United States
Northwell Health
RECRUITING

New York, New York, 21287, United States
Ochsner Clinic
RECRUITING

New Orleans, Louisiana, 70506, United States
Saint Luke's Hospital of Kansas City
RECRUITING

Kansas City, Missouri, 64111, United States
University Hospitals
WITHDRAWN

Cleveland, Ohio, 44106, United States
University of Maryland
RECRUITING

College Park, Maryland, 20742, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Ottawa Heart Institute
RECRUITING

Ottawa, Ontario, Canada
University of Virginia
NOT_YET_RECRUITING

Charlottesville, Virginia, 22903, United States
West Virginia University
RECRUITING

Morgantown, West Virginia, 26506, United States

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