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ACTIVE NOT RECRUITING
NCT05478304
NA

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Sponsor: AtriCure, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6573

Start Date

2023-01-25

Completion Date

2032-04

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

DEVICE

AtriClip LAA Exclusion System

LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery

Locations (138)

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

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

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. Joseph 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

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

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