ACTIVE_NOT_RECRUITING

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

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Conditions

Ischemic StrokeSystemic Embolism

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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 trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

Official Title

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Quick Facts

Study Start:2023-01-25
Study Completion:2032-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05478304

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects ≥ 18 years of age
  2. * Documentation of any of the following clinical criteria:
  3. * CHA2DS2-VASc ≥ 4 with age ≥ 65
  4. * CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP
  5. * CHA2DS2-VASc = 3 with age ≥ 75
  6. * CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
  7. * CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP
  1. * Clinically significant atrial fibrillation or atrial flutter:
  2. * Anytime in the past and
  3. * Documented by an electrocardiographic recording and
  4. * Episode lasting 6 minutes or longer1\*
  5. * Prior procedure involving opening the pericardium or entering the pericardial space
  6. * Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
  7. * Planned cardiac surgical procedure using non-sternotomy approaches
  8. * Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
  9. * Active endocarditis
  10. * Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms
  11. * Known allergy to Nitinol or nickel sensitivity
  12. * Known medical condition with expected survival of less than 1 year
  13. * Other comorbidities that in the investigator's opinion make the subject unsuitable candidate to complete the protocol required visits.
  14. * Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial.
  15. * Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
  16. * Pregnancy
  17. * Known severe symptomatic carotid disease

Contacts and Locations

Principal Investigator

Richard Whitlock, MD
STUDY_CHAIR
McMaster University

Study Locations (Sites)

Heart Center Research / Huntsville Hospital
Huntsville, Alabama, 35801
United States
HonorHealth Shea Scottsdale Healthcare
Scottsdale, Arizona, 85258
United States
St. Bernard's Heart & Vascular
Jonesboro, Arkansas, 72401
United States
CHI St. Vincent
Little Rock, Arkansas, 72205
United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
United States
Memorial Care Long Beach Medical Center
Long Beach, California, 90806
United States
Keck Medical Center of USC
Los Angeles, California, 90033
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
Sutter Sacramento Hospital
Sacramento, California, 95816
United States
Stanford University
Stanford, California, 94305
United States
University of Colorado
Boulder, Colorado, 80309
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
Christiana Care Health Services
Newark, Delaware, 19718
United States
Medstar Washington Hospital Center
Washington, District of Columbia, 20010
United States
HCA Florida JFK Hospital
Atlantis, Florida, 33462
United States
HealthPark Medical Center
Fort Myers, Florida, 33908
United States
University of Florida Hospital
Gainesville, Florida, 32610
United States
Memorial Regional Hospital
Hollywood, Florida, 33021
United States
Baptist Health Jacksonville
Jacksonville, Florida, 32207
United States
Baptist Health South Florida
Miami, Florida, 33176
United States
Advent South
Orlando, Florida, 32803
United States
Orlando Regional Medical Center
Orlando, Florida, 32806
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Baycare Health System
Tampa, Florida, 33607
United States
Emory University Hospital
Atlanta, Georgia, 30308
United States
Piedmont Hospital
Atlanta, Georgia, 30309
United States
Wellstar - Kennestone
Marietta, Georgia, 30060
United States
St. Luke's Regional Medical Center
Boise, Idaho, 83712
United States
Portneuf Medical Center
Idaho Falls, Idaho, 83404
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Memorial Hospital (SIU Medicine)
Springfield, Illinois, 62702
United States
Ascension St. Vincent
Carmel, Indiana, 46290
United States
Franciscan
Indianapolis, Indiana, 46237
United States
Mercy Medical Center
Des Moines, Iowa, 50266
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52245
United States
St. Luke's Hospital
Kansas City, Kansas, 64111
United States
Kansas University Medical Center
Kansas City, Kansas, 66160
United States
Baptist Health
Lexington, Kentucky, 40503
United States
University of Kentucky
Lexington, Kentucky, 40536
United States
Norton Healthcare
Louisville, Kentucky, 40202
United States
University of Louisville Health / Jewish Hospital
Louisville, Kentucky, 40202
United States
Novant Presbyterian Hospital
Louisville, Kentucky, 40205
United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, 70808
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Corewell Health
Grand Rapids, Michigan, 49503
United States
Corewell Health East
Royal Oak, Michigan, 48073
United States
Munson Medical Center
Traverse City, Michigan, 49684
United States
Trinity Health (formerly St. Joesph Mercy)
Ypsilanti, Michigan, 48197
United States
Mercy Medical Center
Coon Rapids, Minnesota, 55433
United States
Abbott Northwestern / Minneapolis Heart
Minneapolis, Minnesota, 55407
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801
United States
Midwest Heart and Vascular (HCA)
Kansas City, Missouri, 64132
United States
St. Lukes Hospital
Saint Louis, Missouri, 63017
United States
Washington University
Saint Louis, Missouri, 63110
United States
Mercy Hospital St. Louis
Saint Louis, Missouri, 63141
United States
Nebraska Methodist
Omaha, Nebraska, 68114
United States
The Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Rutgers Robert Woods Johnson Medical School
New Brunswick, New Jersey, 08903
United States
The Valley Hospital
Paramus, New Jersey, 07552
United States
North Shore University Hospital (Northwell)
Manhasset, New York, 11030
United States
St. Francis Hospital
Roslyn, New York, 11576
United States
St. Joseph Hospital
Syracuse, New York, 13203
United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
United States
Duke University
Durham, North Carolina, 27705
United States
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610
United States
Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
TriHealth / Bethesda North Hospital
Cincinnati, Ohio, 45202
United States
Christ Hospital / Lindner Research Center
Cincinnati, Ohio, 45219
United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Ohio State Medical Center
Columbus, Ohio, 43210
United States
Riverside Methodist
Columbus, Ohio, 43214
United States
The Toledo Hospital (Promedica)
Toledo, Ohio, 43606
United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
United States
UPMC Pinnacle
Harrisburg, Pennsylvania, 17050
United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
UPMC Health System
Pittsburgh, Pennsylvania, 15232
United States
Lankenau Hospital
Wynnewood, Pennsylvania, 19096
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
United States
Sanford USD Medical Center
Sioux Falls, South Dakota, 57105
United States
Jackson Madison County General
Jackson, Tennessee, 38301
United States
Centennial Medical Center (TriStar)
Nashville, Tennessee, 37203
United States
Ascension St. Thomas West
Nashville, Tennessee, 37205
United States
UT Dell Medical School
Austin, Texas, 78705
United States
HCA Medical City Dallas
Dallas, Texas, 75243
United States
University of Texas Southwestern
Dallas, Texas, 75390
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Baylor Heart Hospital - Plano
Plano, Texas, 75093
United States
Trinity Mother Frances (CHRISTUS)
Tyler, Texas, 75702
United States
University of Utah
Salt Lake City, Utah, 84132
United States
Inova Fairfax Medical
Falls Church, Virginia, 22042
United States
Sentara Hospitals & Sentara Medical Group
Norfolk, Virginia, 23507
United States
Swedish Heart and Vascular Research
Seattle, Washington, 98122
United States
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, 25301
United States
West Virginia University
Morgantown, West Virginia, 26506
United States
Columbia St. Mary's
Milwaukee, Wisconsin, 53211
United States
Aspirus Hospital
Wausau, Wisconsin, 54401
United States

Collaborators and Investigators

Sponsor: AtriCure, Inc.

  • Richard Whitlock, MD, STUDY_CHAIR, McMaster University

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 Date2023-01-25
Study Completion Date2032-04

Study Record Updates

Study Start Date2023-01-25
Study Completion Date2032-04

Terms related to this study

Additional Relevant MeSH Terms

  • Ischemic Stroke
  • Systemic Embolism