Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

NCT05478304 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CP-2021-05
• Study Type: interventional
• Target: 6,573
• Locations: 9 countries
• Sites: 136

Brief 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.

Conditions

Ischemic Stroke; Systemic Embolism

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint

  Time to the first occurrence of ischemic stroke or systemic arterial embolism as adjudicated by the Clinical Events Committee (CEC), or any procedure wherein the LAA was excluded, occluded, or amputated following the index procedure.

  Common termination point (median follow-up for 5 years)

• Primary Safety Endpoint

  Occurrence of at least one of the following events assessed through 30 days post index procedure: * Pericardial effusion requiring percutaneous or surgical treatment * Major bleeding attributable to index surgical procedure * Deep sternal wound infection * Myocardial infarction

  30 days post index procedure

Secondary Outcomes (1)

• Powered Secondary Effectiveness endpoint

  Common termination point (median follow-up for 5 years)

Study Arms (2)

Treatment

EXPERIMENTAL

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

Device: AtriClip LAA Exclusion System

Control

NO INTERVENTION

No LAAE concomitant to and at the time of planned cardiac surgery

Interventions

AtriClip LAA Exclusion System DEVICE

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Clinically significant atrial fibrillation or atrial flutter:
• 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
• 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.

Sponsors & Collaborators

• AtriCure, Inc.: lead
• Population Health Research Institute: collaborator

Study Sites (138)

Heart Center Research / Huntsville Hospital

Huntsville, Alabama, 35801, United States

Location

HonorHealth Shea Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

St. Bernard's Heart & Vascular

Jonesboro, Arkansas, 72401, United States

Location

CHI St. Vincent

Little Rock, Arkansas, 72205, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Memorial Care Long Beach Medical Center

Long Beach, California, 90806, United States

Location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Sutter Sacramento Hospital

Sacramento, California, 95816, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado

Boulder, Colorado, 80309, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

HCA Florida JFK Hospital

Atlantis, Florida, 33462, United States

Location

HealthPark Medical Center

Fort Myers, Florida, 33908, United States

Location

University of Florida Hospital

Gainesville, Florida, 32610, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Baptist Health Jacksonville

Jacksonville, Florida, 32207, United States

Location

Baptist Health South Florida

Miami, Florida, 33176, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Baycare Health System

Tampa, Florida, 33607, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Wellstar - Kennestone

Marietta, Georgia, 30060, United States

Location

St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States

Location

Portneuf Medical Center

Idaho Falls, Idaho, 83404, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Memorial Hospital (SIU Medicine)

Springfield, Illinois, 62702, United States

Location

Ascension St. Vincent

Carmel, Indiana, 46290, United States

Location

Franciscan

Indianapolis, Indiana, 46237, United States

Location

Mercy Medical Center

Des Moines, Iowa, 50266, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52245, United States

Location

St. Luke's Hospital

Kansas City, Kansas, 64111, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Baptist Health

Lexington, Kentucky, 40503, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Norton Healthcare

Louisville, Kentucky, 40202, United States

Location

University of Louisville Health / Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Novant Presbyterian Hospital

Louisville, Kentucky, 40205, United States

Location

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, 70808, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Corewell Health

Grand Rapids, Michigan, 49503, United States

Location

Corewell Health East

Royal Oak, Michigan, 48073, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Trinity Health (formerly St. Joseph Mercy)

Ypsilanti, Michigan, 48197, United States

Location

Mercy Medical Center

Coon Rapids, Minnesota, 55433, United States

Location

Abbott Northwestern / Minneapolis Heart

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Midwest Heart and Vascular (HCA)

Kansas City, Missouri, 64132, United States

Location

St. Lukes Hospital

St Louis, Missouri, 63017, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

Nebraska Methodist

Omaha, Nebraska, 68114, United States

Location

The Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

North Shore University Hospital (Northwell)

Manhasset, New York, 11030, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

St. Joseph Hospital

Syracuse, New York, 13203, United States

Location

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States

Location

Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

TriHealth / Bethesda North Hospital

Cincinnati, Ohio, 45202, United States

Location

Christ Hospital / Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State Medical Center

Columbus, Ohio, 43210, United States

Location

Riverside Methodist

Columbus, Ohio, 43214, United States

Location

The Toledo Hospital (Promedica)

Toledo, Ohio, 43606, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

UPMC Pinnacle

Harrisburg, Pennsylvania, 17050, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Health System

Pittsburgh, Pennsylvania, 15232, United States

Location

Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57105, United States

Location

Jackson Madison County General

Jackson, Tennessee, 38301, United States

Location

Centennial Medical Center (TriStar)

Nashville, Tennessee, 37203, United States

Location

Ascension St. Thomas West

Nashville, Tennessee, 37205, United States

Location

UT Dell Medical School

Austin, Texas, 78705, United States

Location

HCA Medical City Dallas

Dallas, Texas, 75243, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Baylor Heart Hospital - Plano

Plano, Texas, 75093, United States

Location

Trinity Mother Frances (CHRISTUS)

Tyler, Texas, 75702, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Inova Fairfax Medical

Falls Church, Virginia, 22042, United States

Location

Sentara Hospitals & Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

Swedish Heart and Vascular Research

Seattle, Washington, 98122, United States

Location

Charleston Area Medical Center (CAMC)

Charleston, West Virginia, 25301, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Aspirus Hospital

Wausau, Wisconsin, 54401, United States

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Victorian Heart Hospital and Monash University

Clayton, Victoria, 3168, Australia

Location

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Medical University Hospital Graz

Graz, Styria, 8036, Austria

Location

Medical University Vienna

Vienna, 1090, Austria

Location

University Hospitals UZ Leuven

Leuven, Brabant, 3000, Belgium

Location

UZ Brussels

Jette, Brussels Capital, 1090, Belgium

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

New Brunswick Heart Centre

Saint John, New Brunswick, E2L 4L2, Canada

Location

Queen Elizabeth II - Nova Scotia Health

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H1T 1C8, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

IUCPQ Hosptial Laval

Québec, G1V 4G5, Canada

Location

CKTCH Brno

Brno, 602 00, Czechia

Location

University Heart Venter Freiburg Bad Krozingen

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Rhön-Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, Bavaria, 97616, Germany

Location

Deutsches Herzzentrum der Charité

Berlin, Brandenburg, 13353, Germany

Location

Bad Rothefelde Schüchtermann-Klinik

Bad Rothenfelde, Lower Saxony, 49 49214, Germany

Location

University Heart and Vascular Center Hamburg

Hamburg, 20246, Germany

Location

Albertinen Krankenhaus

Hamburg, 22457, Germany

Location

Waikato Hospital-Hamilton

Hamilton, Waikato Region, 3240, New Zealand

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Northern General Hospital

Sheffield, Great Britain, S5 7AU, United Kingdom

Location

St. Bartholomew's Hospital

London, Greater London, EC1A 7BE, United Kingdom

Location

The James Cook University Hospital

Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom

Location

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Royal Papworth Hospital

Cambridge, CB2 0AY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39395566 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Richard Whitlock, MD

  McMaster University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 28, 2022
• Study Start: January 25, 2023
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): April 1, 2032
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); NZ (1); DE (6); AU (3); BE (2); GB (5); US (102); CA (14); ES (2)