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

NCT ID NCT06027788

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 842 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.