New device aims to catch surgical debris, prevent stroke and kidney damage
NCT ID NCT06027788
First seen May 30, 2026 · Last updated Jun 22, 2026 · Updated 3 times
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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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CHI St. Vincent Heart Institute
RECRUITINGNorth Little Rock, Arkansas, 72117, United States
Contact Email: •••••@•••••
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
Contact Email: •••••@•••••
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Columbia University Medical Center
RECRUITINGNew York, New York, 10032, United States
Contact Email: •••••@•••••
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Duke University
RECRUITINGDurham, North Carolina, 27710, United States
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Contact Email: •••••@•••••
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Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
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Contact Email: •••••@•••••
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Hospital of the University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
Contact Email: •••••@•••••
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Hôpital Laval
NOT_YET_RECRUITINGQuébec, Quebec, QC G1V 4G5, Canada
Contact Email: •••••@•••••
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Indiana Ohio Heart
WITHDRAWNFort Wayne, Indiana, 46804, United States
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Indiana University
WITHDRAWNBloomington, Indiana, 47405, United States
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Johns Hopkins Medicine
RECRUITINGBaltimore, Maryland, 21287, United States
Contact
Contact Email: •••••@•••••
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Keck Hospital of the University of Southern California
RECRUITINGLos Angeles, California, 90033, United States
Contact Email: •••••@•••••
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London Health Sciences Centre
RECRUITINGLondon, Ontario, Canada
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Contact Email: •••••@•••••
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Maine Medical Center
RECRUITINGPortland, Maine, 04102, United States
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Contact Email: •••••@•••••
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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Montefiore Medical Center
RECRUITINGThe Bronx, New York, 10467, United States
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Montreal Heart Institute
NOT_YET_RECRUITINGMontreal, Quebec, Canada
Contact Email: •••••@•••••
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NYU Langone Hospital Brooklyn
WITHDRAWNNew York, New York, 11220, United States
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New York Presbyterian-Cornell Medical Center
WITHDRAWNNew York, New York, 10065, United States
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Northwell Health
RECRUITINGNew York, New York, 21287, United States
Contact Email: •••••@•••••
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Ochsner Clinic
RECRUITINGNew Orleans, Louisiana, 70506, United States
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Contact Email: •••••@•••••
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Saint Luke's Hospital of Kansas City
RECRUITINGKansas City, Missouri, 64111, United States
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Contact Email: •••••@•••••
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University Hospitals
WITHDRAWNCleveland, Ohio, 44106, United States
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University of Maryland
RECRUITINGCollege Park, Maryland, 20742, United States
Contact Email: •••••@•••••
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
Contact Email: •••••@•••••
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University of Ottawa Heart Institute
RECRUITINGOttawa, Ontario, Canada
Contact Email: •••••@•••••
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University of Virginia
NOT_YET_RECRUITINGCharlottesville, Virginia, 22903, United States
Contact Email: •••••@•••••
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West Virginia University
RECRUITINGMorgantown, West Virginia, 26506, United States
Contact
Contact Email: •••••@•••••
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.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.