RECRUITING

CTSN Embolic Protection Trial

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Conditions

DeliriumIschemic StrokeAcute Kidney InjuryHeart Valve DiseaseCoronary Artery DiseaseEmbolic ProtectionCardiac SurgeryCardioGard

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Embolic Protection in Patients Undergoing High-Risk Valve Surgery

Quick Facts

Study Start:2023-09-06
Study Completion:2027-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06027788

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.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 60 years
  2. * Planned de novo or redo:
  3. * Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory arrest is not required) ± CABG
  4. * Mitral valve replacement (MVR) ± CABG
  5. * Mitral Valve Repair + CABG,
  6. * 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.
  7. * No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 7 days prior to randomization
  8. * Ability to provide informed consent and comply with the protocol Exclusion Criteria
  1. * History of clinical stroke within 3 months prior to randomization
  2. * Cerebral and or aortic arch arteriography or interventions within 3 days of the planned procedure
  3. * Coronary catheterization within 3 days of the planned procedure
  4. * Active endocarditis at time of randomization with vegetation criteria
  5. * Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
  6. * Participation in an interventional (drug or device) trial
  7. * Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair
  8. * Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigator

Contacts and Locations

Study Contact

Ellen Moquete
CONTACT
212-659-9651
ellen.moquete@mountsinai.org
Claudia Merlin
CONTACT
917-494-2387
Claudia.merlin@mountsinai.org

Principal Investigator

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 Locations (Sites)

CHI St. Vincent Heart Institute
North Little Rock, Arkansas, 72117
United States
Keck Hospital of the University of Southern California
Los Angeles, California, 90033
United States
Indiana Ohio Heart
Thousand Oaks, California, 91360
United States
Emory University
Atlanta, Georgia, 30322
United States
Indiana University
Bloomington, Indiana, 47405
United States
Ochsner Clinic
New Orleans, Louisiana, 70506
United States
Maine Medical Center
Portland, Maine, 04102
United States
Johns Hopkins Medicine
Baltimore, Maryland, 21287
United States
University of Maryland
College Park, Maryland, 20742
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
NYU Langone Hospital Brooklyn
New York, New York, 11220
United States
Northwell Health
New York, New York, 21287
United States
Duke University
Durham, North Carolina, 27710
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-06
Study Completion Date2027-04-01

Study Record Updates

Study Start Date2023-09-06
Study Completion Date2027-04-01

Terms related to this study

Keywords Provided by Researchers

  • Embolic Protection
  • Cardiac Surgery
  • CardioGard

Additional Relevant MeSH Terms

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