CTSN Embolic Protection Trial

NCT06027788 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY-23-004175U01HL088942-16
• Study Type: interventional
• Target: 842
• Locations: 2 countries
• Sites: 28

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

Keywords

Embolic Protection; Cardiac Surgery; CardioGard

Outcome Measures

Primary Outcomes (2)

• Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)

  The combined number of patients who experience clinical ischemic strokes and acute kidney injuries that have occurred within 3 days post-randomization.

  within 3 days post-randomization

• Number of patients who experience of death and delirium

  The combined number of patients who experience death and delirium by 7 days post-randomization (with a blanking period for delirium of days 1 and 2 post-operatively).

  by 7 days post-randomization

Secondary Outcomes (38)

• Proportion of patients who experience a clinical ischemic stroke

  within 3 days post-randomization

• Proportion of patients who experience a clinical ischemic stroke

  within 7 days post-randomization

• Number of patients with disabling clinical stroke

  within 3 days post-randomization

• Number of patients with disabling clinical stroke

  within 7 days post-randomization

• Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)

  within 3 days post-randomization

Study Arms (2)

CardioGard Embolic Protection Cannula

ACTIVE COMPARATOR

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).

Device: CardioGard Embolic Protection Cannula

Standard Aortic Cannula

PLACEBO COMPARATOR

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

Device: Standard Aortic Cannula

Interventions

CardioGard Embolic Protection Cannula DEVICE

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.

CardioGard Embolic Protection Cannula

Standard Aortic Cannula DEVICE

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.

Standard Aortic Cannula

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (28)

CHI St. Vincent Heart Institute

North Little Rock, Arkansas, 72117, United States

RECRUITING

Keck Hospital of the University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Indiana University

Bloomington, Indiana, 47405, United States

NOT YET RECRUITING

Indiana Ohio Heart

Fort Wayne, Indiana, 46804, United States

RECRUITING

Ochsner Clinic

New Orleans, Louisiana, 70506, United States

RECRUITING

Maine Medical Center

Portland, Maine, 04102, United States

RECRUITING

Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

University of Maryland

College Park, Maryland, 20742, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

New York Presbyterian-Cornell Medical Center

New York, New York, 10065, United States

NOT YET RECRUITING

NYU Langone Hospital Brooklyn

New York, New York, 11220, United States

RECRUITING

Northwell Health

New York, New York, 21287, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

University Hospitals

Cleveland, Ohio, 44106, United States

NOT YET RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

NOT YET RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

London Health Sciences Centre

London, Ontario, Canada

NOT YET RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

NOT YET RECRUITING

Montreal Heart Institute

Montreal, Quebec, Canada

NOT YET RECRUITING

Hôpital Laval

Québec, Quebec, QC G1V 4G5, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Delirium; Ischemic Stroke; Acute Kidney Injury; Heart Valve Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Annetine C. Gelijns, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Steve Messe, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Alexander Iribarne, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Merlin

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The nature of the study precludes masking surgeons from treatment assignment. Investigators will, however, be blinded to all data from other clinical sites, except serious unexpected adverse events possibly or probably related to the intervention for Institutional Review Board (IRB)/Research Ethics Board (REB) reporting purposes. Patients will be blinded as to treatment assignment. All neurocognitive scoring and delirium assessments will be analyzed by neurocognitive core laboratory personnel who will be blinded to treatment assignment and clinical outcomes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Policy, Chair Department of Health Evidence & Policy

Model Details: Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the OR immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device).

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 7, 2023
• Study Start: September 18, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.
• Access Criteria: Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link to be included in the URL field below).

Locations

US (24); CA (4)