CTSN Embolic Protection Trial

Description

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

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Study Overview

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Study Details

Study overview

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

Embolic Protection in Patients Undergoing High-Risk Valve Surgery

CTSN Embolic Protection Trial

Condition
Delirium
Intervention / Treatment

-

Contacts and Locations

North Little Rock

CHI St. Vincent Heart Institute, North Little Rock, Arkansas, United States, 72117

Los Angeles

Keck Hospital of the University of Southern California, Los Angeles, California, United States, 90033

Thousand Oaks

Indiana Ohio Heart, Thousand Oaks, California, United States, 91360

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Bloomington

Indiana University, Bloomington, Indiana, United States, 47405

New Orleans

Ochsner Clinic, New Orleans, Louisiana, United States, 70506

Portland

Maine Medical Center, Portland, Maine, United States, 04102

Baltimore

Johns Hopkins Medicine, Baltimore, Maryland, United States, 21287

College Park

University of Maryland, College Park, Maryland, United States, 20742

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 7 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 the planned procedure
  • * 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

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

Annetine C. Gelijns, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Steve Messe, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Alexander Iribarne, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

2027-04-01