Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Status: Active_not_recruiting
Location: See all (142) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subjects ≥ 18 years of age
• Documentation of any of the following clinical criteria:
‣ CHA2DS2-VASc ≥ 4 with age ≥ 65
⁃ CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP
⁃ CHA2DS2-VASc = 3 with age ≥ 75
⁃ CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
⁃ CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP
Locations
United States
Alabama
Heart Center Research / Huntsville Hospital
Huntsville
Arkansas
St. Bernard's Heart & Vascular
Jonesboro
Arkansas Heart Hospital
Little Rock
CHI St. Vincent
Little Rock
Arizona
HonorHealth Shea Scottsdale Healthcare
Scottsdale
California
Memorial Care Long Beach Medical Center
Long Beach
Keck Medical Center of USC
Los Angeles
Hoag Memorial Hospital Presbyterian
Newport Beach
Sutter Sacramento Hospital
Sacramento
Stanford University
Stanford
Colorado
University of Colorado
Boulder
Connecticut
Hartford Hospital
Hartford
Washington, D.c.
Medstar Washington Hospital Center
Washington D.c.
Delaware
Christiana Care Health Services
Newark
Florida
HCA Florida JFK Hospital
Atlantis
HealthPark Medical Center
Fort Myers
University of Florida Hospital
Gainesville
Memorial Regional Hospital
Hollywood
Baptist Health Jacksonville
Jacksonville
Baptist Health South Florida
Miami
Advent South
Orlando
Orlando Regional Medical Center
Orlando
Sarasota Memorial Hospital
Sarasota
Baycare Health System
Tampa
Tampa General Hospital
Tampa
Georgia
Emory University Hospital
Atlanta
Piedmont Hospital
Atlanta
Wellstar - Kennestone
Marietta
Iowa
Mercy Medical Center
Des Moines
University of Iowa Hospitals and Clinics
Iowa City
Idaho
St. Luke's Regional Medical Center
Boise
Portneuf Medical Center
Idaho Falls
Illinois
Northwestern Memorial Hospital
Chicago
Loyola University Medical Center
Maywood
Memorial Hospital (SIU Medicine)
Springfield
Indiana
Ascension St. Vincent
Carmel
Franciscan
Indianapolis
Kansas
Kansas University Medical Center
Kansas City
St. Luke's Hospital
Kansas City
Kentucky
Baptist Health
Lexington
University of Kentucky
Lexington
Norton Healthcare
Louisville
Novant Presbyterian Hospital
Louisville
University of Louisville Health / Jewish Hospital
Louisville
Louisiana
Our Lady of the Lake Hospital
Baton Rouge
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Tufts Medical Center
Boston
Maryland
Johns Hopkins Hospital
Baltimore
Michigan
University of Michigan
Ann Arbor
Corewell Health
Grand Rapids
Corewell Health East
Royal Oak
Munson Medical Center
Traverse City
Trinity Health (formerly St. Joesph Mercy)
Ypsilanti
Minnesota
Mercy Medical Center
Coon Rapids
Abbott Northwestern / Minneapolis Heart
Minneapolis
Mayo Clinic
Rochester
Missouri
Midwest Heart and Vascular (HCA)
Kansas City
Mercy Hospital St. Louis
St Louis
St. Lukes Hospital
St Louis
Washington University
St Louis
Mississippi
North Mississippi Medical Center
Tupelo
North Carolina
Atrium Health Carolinas Medical Center
Charlotte
Duke University
Durham
WakeMed Health & Hospitals
Raleigh
Wake Forest Baptist
Winston-salem
Nebraska
Nebraska Methodist
Omaha
The Nebraska Medical Center
Omaha
New Jersey
Hackensack University Medical Center
Hackensack
Rutgers Robert Woods Johnson Medical School
New Brunswick
The Valley Hospital
Paramus
New York
North Shore University Hospital (Northwell)
Manhasset
St. Francis Hospital
Roslyn
St. Joseph Hospital
Syracuse
Ohio
Christ Hospital / Lindner Research Center
Cincinnati
TriHealth / Bethesda North Hospital
Cincinnati
Cleveland Clinic Foundation
Cleveland
University Hospitals of Cleveland
Cleveland
Ohio State Medical Center
Columbus
Riverside Methodist
Columbus
The Toledo Hospital (Promedica)
Toledo
Pennsylvania
Lehigh Valley Health Network
Allentown
UPMC Pinnacle
Harrisburg
Lancaster General Hospital
Lancaster
Allegheny General Hospital
Pittsburgh
UPMC Health System
Pittsburgh
Lankenau Hospital
Wynnewood
South Carolina
Medical University of South Carolina (MUSC)
Charleston
South Dakota
Sanford USD Medical Center
Sioux Falls
Tennessee
Jackson Madison County General
Jackson
Ascension St. Thomas West
Nashville
Centennial Medical Center (TriStar)
Nashville
Texas
UT Dell Medical School
Austin
HCA Medical City Dallas
Dallas
University of Texas Southwestern
Dallas
Houston Methodist Hospital
Houston
Baylor Heart Hospital - Plano
Plano
Trinity Mother Frances (CHRISTUS)
Tyler
Utah
University of Utah
Salt Lake City
Virginia
Inova Fairfax Medical
Falls Church
Sentara Hospitals & Sentara Medical Group
Norfolk
Washington
Swedish Heart and Vascular Research
Seattle
Wisconsin
Columbia St. Mary's
Milwaukee
Aspirus Hospital
Wausau
West Virginia
Charleston Area Medical Center (CAMC)
Charleston
West Virginia University
Morgantown
Other Locations
Australia
Victorian Heart Hospital and Monash University
Clayton
St. Vincent's Hospital Melbourne
Fitzroy
Gold Coast University Hospital
Southport
Austria
Medical University Hospital Graz
Graz
Medical University Vienna
Vienna
Belgium
UZ Brussels
Jette
University Hospitals UZ Leuven
Leuven
Canada
Foothills Medical Centre
Calgary
University of Alberta Hospital
Edmonton
Queen Elizabeth II - Nova Scotia Health
Halifax
Hamilton General Hospital
Hamilton
Kingston General Hospital
Kingston
London Health Sciences Centre
London
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal
Montreal Heart Institute
Montreal
Royal Columbian Hospital
New Westminster
Ottawa Heart Institute
Ottawa
IUCPQ Hosptial Laval
Québec
New Brunswick Heart Centre
Saint John
St Michael's Hospital
Toronto
Toronto General Hospital
Toronto
Germany
Rhön-Klinikum Campus Bad Neustadt
Bad Neustadt An Der Saale
Bad Rothefelde Schüchtermann-Klinik
Bad Rothenfelde
Deutsches Herzzentrum der Charité
Berlin
University Heart Venter Freiburg Bad Krozingen
Freiburg Im Breisgau
Albertinen Krankenhaus
Hamburg
University Heart and Vascular Center Hamburg
Hamburg
New Zealand
Waikato Hospital-Hamilton
Hamilton
Spain
Hospital Clinic Barcelona
Barcelona
Hospital Clinico San Carlos
Madrid
United Kingdom
Royal Papworth Hospital
Cambridge
St. Bartholomew's Hospital
London
The James Cook University Hospital
Middlesbrough
Northern General Hospital
Sheffield
The Royal Wolverhampton NHS Trust
Wolverhampton
Time Frame
Start Date: 2023-01-25
Completion Date: 2032-04
Participants
Target number of participants: 6573
Treatments
Experimental: Treatment
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
No_intervention: Control
No LAAE concomitant to and at the time of planned cardiac surgery
Related Therapeutic Areas
Sponsors
Collaborators: Population Health Research Institute
Leads: AtriCure, Inc.