Recruiting

Embolic Protection

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06027788

Conditions

Delirium

Ischemic Stroke

Acute Kidney Injury

Heart Valve Disease

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

CardioGard Embolic Protection Cannula

Standard Aortic Cannula

Study Details

Brief summary:

This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.

Conditions

Delirium

Ischemic Stroke

Acute Kidney Injury

Heart Valve Disease

Coronary Artery Disease

Study ID

NCT06027788

Start date

Sep 18, 2023

Status verified date

May, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 60 years
  • Planned de novo or redo:

  • Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory arrest is not required) ± CABG
  • Mitral valve replacement (MVR) ± CABG
  • Mitral Valve Repair + CABG,
  • Double/Triple valve surgery ± CABG; Ross procedure These procedures can be done via a full or minimal-access sternotomy (using central aortic perfusion cannulae) with legally marketed valve(s), and can be done in combination with an left atrial appendage (LAA) closure/excision or partial/complete Maze procedure.
  • Valve sparing aortic root replacement (David procedure)
  • Valve sparing aortic root replacement (David procedure)
  • No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 30 days prior to randomization
  • Ability to provide informed consent and comply with the protocol

Exclusion Criteria:

  • History of clinical stroke within 3 months prior to randomization
  • Cerebral and or aortic arch arteriography or interventions within 3 days of the planned procedure
  • Coronary catheterization within 3 days of index procedure, and the required repeat NIHSS score post-catheterization is worse than the screening/baseline NIHSS score conducted prior to the catheterization
  • Active endocarditis at time of randomization with vegetation criteria
  • Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
  • Participation in an interventional (drug or device) trial
  • Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair
  • Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigator
  • Planned concomitant carotid endarterectomy during index surgical procedure

Study Design

Enrollment

842 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: CardioGard Embolic Protection Cannula

In patients assigned to the embolic protection device group, the CardioGard Embolic Protection Cannula is used instead, according to the manufacturer's instructions for use (IFU).

placebo comparator: Standard Aortic Cannula

In patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice

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.

Primary outcome measure

  • Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI) [ Time Frame: within 3 days post-randomization ]
  • Number of patients who experience of death and delirium [ Time Frame: by 7 days post-randomization ]

Central Contacts and Locations

Central contacts

Claudia Merlin

917-494-2387Claudia.merlin@mountsinai.org

Locations

CHI St. Vincent Heart Institute

Recruiting

North Little Rock, Arkansas, United States, 72117

Contacts

Lynn Bass

Lynn.bass@commonspirit.org

Principal Investigator:

Thurston Bauer

Keck Hospital of the University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Edward Lozano

edwardlo@med.usc.edu

Principal Investigator:

Vaughn Starnes

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Sonya Mathewson

sbmathe@emory.edu

Principal Investigator:

Michael Halkos

Ochsner Clinic

Recruiting

New Orleans, Louisiana, United States, 70506

Contacts

Nicolle Scholl

nicolle.scholl@ochsner.org

Principal Investigator:

Eugene Parrino

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Contacts

Monica Palmeri

Monica.Palmeri@mainehealth.org

Principal Investigator:

Ansar Hassan

Johns Hopkins Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Lisa Fornaresio, PhD

lisa.fornaresio@jhmi.edu

Principal Investigator:

James S Gammie

University of Maryland

Recruiting

College Park, Maryland, United States, 20742

Contacts

Kaitlyn Masih

KMasih@som.umaryland.edu

Principal Investigator:

Mehrdad Ghoreishi

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Ana M Pico

APICO@mgh.harvard.edu

Principal Investigator:

Nathaniel Langer

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

China Green

chjgreen@med.umich.edu

Principal Investigator:

Gorav Ailawadi

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jennifer Martin

Martin.Jennifer2@mayo.edu

Principal Investigator:

Paul Tang

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Rosann Gans

rgans@saint-lukes.org

Principal Investigator:

Keith Allen

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Bo Lu

bl2699@cumc.columbia.edu

Principal Investigator:

Isaac George

Northwell Health

Recruiting

New York, New York, United States, 21287

Contacts

Kristine Gowan

KMcGowan@northwell.edu

Principal Investigator:

Pey-Jen Yu

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Agnieszka Siemienik

asiemien@montefiore.org

Principal Investigator:

Daniel Goldstein

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Mary Motta

mary.motta@duke.edu

Principal Investigator:

Jeffrey Gaca

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Anna M Simmons

SIMMONA8@ccf.org

Principal Investigator:

Marc Gillinov

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Mary L Mayer

marylou.mayer@uphs.upenn.edu

Principal Investigator:

Michael Acker

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Misa Shaw

misa.shaw1@wvumedicine.org

Principal Investigator:

James Mehaffey

London Health Sciences Centre

Recruiting

London, Ontario, Canada

Contacts

Stephanie Fox

Stephanie.Fox@lhsc.on.ca

Principal Investigator:

Michael Chu

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada

Contacts

Nahya Awada

naawada@ottawaheart.ca

Principal Investigator:

Pierre Voisine

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Embolic Protection
  • Cardiac Surgery
  • CardioGard

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-05-29.