Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
NCT ID: NCT05478304
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
6573 participants
INTERVENTIONAL
2023-01-25
2032-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
AtriClip LAA Exclusion System
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
Control
No LAAE concomitant to and at the time of planned cardiac surgery
No interventions assigned to this group
Interventions
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AtriClip LAA Exclusion System
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Anytime in the past and
* Documented by an electrocardiographic recording and
* Episode lasting 6 minutes or longer1\*
* Prior procedure involving opening the pericardium or entering the pericardial space
* Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
* Planned cardiac surgical procedure using non-sternotomy approaches
o Partial sternotomies will be allowed.
* Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
* Active endocarditis
* Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms
* Known allergy to Nitinol or nickel sensitivity
* Known medical condition with expected survival of less than 1 year
* Other comorbidities that in the investigator's opinion make the subject unsuitable candidate to complete the protocol required visits.
* Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial.
* Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
* Pregnancy
* Known severe symptomatic carotid disease
18 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
AtriCure, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Whitlock, MD
Role: STUDY_CHAIR
McMaster University
Locations
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Heart Center Research / Huntsville Hospital
Huntsville, Alabama, United States
HonorHealth Shea Scottsdale Healthcare
Scottsdale, Arizona, United States
St. Bernard's Heart & Vascular
Jonesboro, Arkansas, United States
CHI St. Vincent
Little Rock, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Memorial Care Long Beach Medical Center
Long Beach, California, United States
Keck Medical Center of USC
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Sutter Sacramento Hospital
Sacramento, California, United States
Stanford University
Stanford, California, United States
University of Colorado
Boulder, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Christiana Care Health Services
Newark, Delaware, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
HCA Florida JFK Hospital
Atlantis, Florida, United States
HealthPark Medical Center
Fort Myers, Florida, United States
University of Florida Hospital
Gainesville, Florida, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Baptist Health Jacksonville
Jacksonville, Florida, United States
Baptist Health South Florida
Miami, Florida, United States
Advent South
Orlando, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Baycare Health System
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Piedmont Hospital
Atlanta, Georgia, United States
Wellstar - Kennestone
Marietta, Georgia, United States
St. Luke's Regional Medical Center
Boise, Idaho, United States
Portneuf Medical Center
Idaho Falls, Idaho, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Memorial Hospital (SIU Medicine)
Springfield, Illinois, United States
Ascension St. Vincent
Carmel, Indiana, United States
Franciscan
Indianapolis, Indiana, United States
Mercy Medical Center
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
St. Luke's Hospital
Kansas City, Kansas, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Baptist Health
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Norton Healthcare
Louisville, Kentucky, United States
University of Louisville Health / Jewish Hospital
Louisville, Kentucky, United States
Novant Presbyterian Hospital
Louisville, Kentucky, United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Corewell Health East
Royal Oak, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Trinity Health (formerly St. Joesph Mercy)
Ypsilanti, Michigan, United States
Mercy Medical Center
Coon Rapids, Minnesota, United States
Abbott Northwestern / Minneapolis Heart
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Midwest Heart and Vascular (HCA)
Kansas City, Missouri, United States
St. Lukes Hospital
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Mercy Hospital St. Louis
St Louis, Missouri, United States
Nebraska Methodist
Omaha, Nebraska, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers Robert Woods Johnson Medical School
New Brunswick, New Jersey, United States
The Valley Hospital
Paramus, New Jersey, United States
North Shore University Hospital (Northwell)
Manhasset, New York, United States
St. Francis Hospital
Roslyn, New York, United States
St. Joseph Hospital
Syracuse, New York, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, United States
Wake Forest Baptist
Winston-Salem, North Carolina, United States
TriHealth / Bethesda North Hospital
Cincinnati, Ohio, United States
Christ Hospital / Lindner Research Center
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State Medical Center
Columbus, Ohio, United States
Riverside Methodist
Columbus, Ohio, United States
The Toledo Hospital (Promedica)
Toledo, Ohio, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
UPMC Pinnacle
Harrisburg, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Health System
Pittsburgh, Pennsylvania, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Jackson Madison County General
Jackson, Tennessee, United States
Centennial Medical Center (TriStar)
Nashville, Tennessee, United States
Ascension St. Thomas West
Nashville, Tennessee, United States
UT Dell Medical School
Austin, Texas, United States
HCA Medical City Dallas
Dallas, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Baylor Heart Hospital - Plano
Plano, Texas, United States
Trinity Mother Frances (CHRISTUS)
Tyler, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Inova Fairfax Medical
Falls Church, Virginia, United States
Sentara Hospitals & Sentara Medical Group
Norfolk, Virginia, United States
Swedish Heart and Vascular Research
Seattle, Washington, United States
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Columbia St. Mary's
Milwaukee, Wisconsin, United States
Aspirus Hospital
Wausau, Wisconsin, United States
Gold Coast University Hospital
Southport, Queensland, Australia
Victorian Heart Hospital and Monash University
Clayton, Victoria, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Medical University Hospital Graz
Graz, Styria, Austria
Medical University Vienna
Vienna, , Austria
University Hospitals UZ Leuven
Leuven, Brabant, Belgium
UZ Brussels
Jette, Brussels Capital, Belgium
Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Royal Columbian Hospital
New Westminster, British Columbia, Canada
New Brunswick Heart Centre
Saint John, New Brunswick, Canada
Queen Elizabeth II - Nova Scotia Health
Halifax, Nova Scotia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Heart Institute
Ottawa, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
IUCPQ Hosptial Laval
Québec, , Canada
CKTCH Brno
Brno, , Czechia
University Heart Venter Freiburg Bad Krozingen
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Rhön-Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, Bavaria, Germany
Deutsches Herzzentrum der Charité
Berlin, Brandenburg, Germany
Bad Rothefelde Schüchtermann-Klinik
Bad Rothenfelde, Lower Saxony, Germany
University Heart and Vascular Center Hamburg
Hamburg, , Germany
Albertinen Krankenhaus
Hamburg, , Germany
Waikato Hospital-Hamilton
Hamilton, Waikato Region, New Zealand
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Northern General Hospital
Sheffield, Great Britain, United Kingdom
St. Bartholomew's Hospital
London, Greater London, United Kingdom
The James Cook University Hospital
Middlesbrough, North Yorkshire, United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom
Royal Papworth Hospital
Cambridge, , United Kingdom
Countries
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References
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Whitlock RP, McCarthy PM, Gerdisch MW, Ramlawi B, Alexander JH, Sultan I, Rose DZ, Healey JS, Sharma YA, Belley-Cote EP, Connolly SJ. The left atrial appendage exclusion for prophylactic stroke reduction (LEAAPS) trial: Rationale and design. Am Heart J. 2025 Jun;284:94-102. doi: 10.1016/j.ahj.2024.10.006. Epub 2024 Oct 11.
Other Identifiers
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CP-2021-05
Identifier Type: -
Identifier Source: org_study_id
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