Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial (LeAAPS)

March 20, 2026 updated by: AtriCure, Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6573

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Gold Coast University Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Victorian Heart Hospital and Monash University
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital Melbourne
  • Austria
      • Vienna, Austria, 1090
        • Medical University Vienna
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University Hospital Graz
  • Belgium
    • Brabant
      • Leuven, Brabant, Belgium, 3000
        • University Hospitals UZ Leuven
    • Brussels Capital
      • Jette, Brussels Capital, Belgium, 1090
        • UZ Brussels
  • Canada
      • Québec, Canada, G1V 4G5
        • IUCPQ Hosptial Laval
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W7
        • Royal Columbian Hospital
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • New Brunswick Heart Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Queen Elizabeth II - Nova Scotia Health
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Montreal, Quebec, Canada, H1T 1C8
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
  • Czechia
      • Brno, Czechia, 602 00
        • CKTCH Brno
  • Germany
      • Hamburg, Germany, 22457
        • Albertinen Krankenhaus
      • Hamburg, Germany, 20246
        • University Heart and Vascular Center Hamburg
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • University Heart Venter Freiburg Bad Krozingen
    • Bavaria
      • Bad Neustadt an der Saale, Bavaria, Germany, 97616
        • Rhön-Klinikum Campus Bad Neustadt
    • Brandenburg
      • Berlin, Brandenburg, Germany, 13353
        • Deutsches Herzzentrum der Charité
    • Lower Saxony
      • Bad Rothenfelde, Lower Saxony, Germany, 49 49214
        • Bad Rothefelde Schüchtermann-Klinik
  • New Zealand
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3240
        • Waikato Hospital-Hamilton
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0AY
        • Royal Papworth Hospital
    • Great Britain
      • Sheffield, Great Britain, United Kingdom, S5 7AU
        • Northern General Hospital
    • Greater London
      • London, Greater London, United Kingdom, EC1A 7BE
        • St. Bartholomew's Hospital
    • North Yorkshire
      • Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW
        • The James Cook University Hospital
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research / Huntsville Hospital
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Shea Scottsdale Healthcare
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • St. Bernard's Heart & Vascular
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
      • Little Rock, Arkansas, United States, 72205
        • CHI St. Vincent
    • California
      • Long Beach, California, United States, 90806
        • Memorial Care Long Beach Medical Center
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
      • Sacramento, California, United States, 95816
        • Sutter Sacramento Hospital
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Boulder, Colorado, United States, 80309
        • University of Colorado
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health Services
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Florida
      • Atlantis, Florida, United States, 33462
        • HCA Florida JFK Hospital
      • Fort Myers, Florida, United States, 33908
        • HealthPark Medical Center
      • Gainesville, Florida, United States, 32610
        • University of Florida Hospital
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Jacksonville, Florida, United States, 32207
        • Baptist Health Jacksonville
      • Miami, Florida, United States, 33176
        • Baptist Health South Florida
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
      • Tampa, Florida, United States, 33607
        • BayCare Health System
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital
      • Marietta, Georgia, United States, 30060
        • Wellstar - Kennestone
    • Idaho
      • Boise, Idaho, United States, 83712
        • St. Luke's Regional Medical Center
      • Idaho Falls, Idaho, United States, 83404
        • Portneuf Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Springfield, Illinois, United States, 62702
        • Memorial Hospital (SIU Medicine)
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Ascension St. Vincent
      • Indianapolis, Indiana, United States, 46237
        • Franciscan
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • Mercy Medical Center
      • Iowa City, Iowa, United States, 52245
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
      • Kansas City, Kansas, United States, 64111
        • St. Luke's Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Health / Jewish Hospital
      • Louisville, Kentucky, United States, 40205
        • Novant Presbyterian Hospital
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health
      • Royal Oak, Michigan, United States, 48073
        • Corewell Health East
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Ypsilanti, Michigan, United States, 48197
        • Trinity Health (formerly St. Joseph Mercy)
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern / Minneapolis Heart
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Midwest Heart and Vascular (HCA)
      • St Louis, Missouri, United States, 63110
        • Washington University
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital St. Louis
      • St Louis, Missouri, United States, 63017
        • St. Lukes Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • The Nebraska Medical Center
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital (Northwell)
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital
      • Syracuse, New York, United States, 13203
        • St. Joseph Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health Carolinas Medical Center
      • Durham, North Carolina, United States, 27705
        • Duke University
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Health & Hospitals
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist
    • Ohio
      • Cincinnati, Ohio, United States, 45202
        • TriHealth / Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45219
        • Christ Hospital / Lindner Research Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist
      • Columbus, Ohio, United States, 43210
        • Ohio State Medical Center
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital (Promedica)
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network
      • Harrisburg, Pennsylvania, United States, 17050
        • UPMC Pinnacle
      • Lancaster, Pennsylvania, United States, 17602
        • Lancaster General Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Health System
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford USD Medical Center
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Jackson Madison County General
      • Nashville, Tennessee, United States, 37205
        • Ascension St. Thomas West
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center (TriStar)
    • Texas
      • Austin, Texas, United States, 78705
        • UT Dell Medical School
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
      • Dallas, Texas, United States, 75243
        • HCA Medical City Dallas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Plano, Texas, United States, 75093
        • Baylor Heart Hospital - Plano
      • Tyler, Texas, United States, 75702
        • Trinity Mother Frances (CHRISTUS)
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • INOVA Fairfax Medical
      • Norfolk, Virginia, United States, 23507
        • Sentara Hospitals & Sentara Medical Group
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Heart and Vascular Research
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Charleston Area Medical Center (CAMC)
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Hospital

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
Device: AtriClip LAA Exclusion System
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint
Time Frame: Common termination point (median follow-up for 5 years)
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
Time Frame: 30 days post index procedure

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Powered Secondary Effectiveness endpoint
Time Frame: Common termination point (median follow-up for 5 years)
Time to the first occurrence of ischemic stroke or systemic arterial embolism
Common termination point (median follow-up for 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AtriCure, Inc.

Collaborators

Population Health Research Institute

Investigators

  • Study Chair: Richard Whitlock, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

April 1, 2032

Study Registration Dates

First Submitted

July 15, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-2021-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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