NCT06027788From ClinicalTrials.govRecruiting

CTSN Embolic Protection Trial

Embolic Protection in Patients Undergoing High-Risk Valve Surgery

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

At a glance

Phase: Phase not stated
Study type: Interventional
Sponsor: Icahn School of Medicine at Mount Sinai
Enrolment target: 842
Started: 18 September 2023
Main results due: 1 April 2027
Study sites: 29
Registry updated: 28 September 2026

Can you take part?

Aged 60 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(29)

CHI St. Vincent Heart Institute
North Little Rock, Arkansas, United States
Recruiting
Keck Hospital of the University of Southern California
Los Angeles, California, United States
Recruiting
Emory University
Atlanta, Georgia, United States
Recruiting
Indiana University
Bloomington, Indiana, United States
Withdrawn
Indiana Ohio Heart
Fort Wayne, Indiana, United States
Withdrawn
Ochsner Clinic
New Orleans, Louisiana, United States
Recruiting
Maine Medical Center
Portland, Maine, United States
Recruiting
Johns Hopkins Medicine
Baltimore, Maryland, United States
Recruiting
University of Maryland
College Park, Maryland, United States
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Recruiting
University of Michigan
Ann Arbor, Michigan, United States
Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Recruiting
Columbia University Medical Center
New York, New York, United States
Recruiting
New York Presbyterian-Cornell Medical Center
New York, New York, United States
Withdrawn
NYU Langone Hospital Brooklyn
New York, New York, United States
Withdrawn
Northwell Health
New York, New York, United States
Recruiting
Montefiore Medical Center
The Bronx, New York, United States
Recruiting
Duke University
Durham, North Carolina, United States
Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Recruiting
University Hospitals
Cleveland, Ohio, United States
Withdrawn
Cleveland Clinic
Cleveland, Ohio, United States
Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recruiting
University of Virginia
Charlottesville, Virginia, United States
Not yet recruiting
West Virginia University
Morgantown, West Virginia, United States
Recruiting
London Health Sciences Centre
London, Ontario, Canada
Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Recruiting
Montreal Heart Institute
Montreal, Quebec, Canada
Not yet recruiting
Hôpital Laval
Québec, Quebec, Canada
Not yet recruiting

Showing 29 of 29 sites. 21 of the 29 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06027788. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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