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Ischemic StrokeLeAAPSNCT05478304

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

A study testing AtriClip LAA Exclusion System in people with Ischemic Stroke and Systemic Embolism, run by AtriCure, Inc. at 138 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Systemic Embolism
What is being tested?
AtriClip LAA Exclusion System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,573 participants
Where
138 sitesin 10 countries
Study dates
25 Jan 2023to Apr 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 18Show fewer
  • 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

Trial locations and contacts

138 sites in 10 countries.

138 sites in 10 countries

United States102 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University Hospital

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • HCA Florida JFK Hospital

    Atlantis, Florida, 33462

  • UT Dell Medical School

    Austin, Texas, 78705

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana, 70808

  • St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of Colorado

    Boulder, Colorado, 80309

  • Ascension St. Vincent

    Carmel, Indiana, 46290

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Charleston Area Medical Center (CAMC)

    Charleston, West Virginia, 25301

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • TriHealth / Bethesda North Hospital

    Cincinnati, Ohio, 45202

  • Christ Hospital / Lindner Research Center

    Cincinnati, Ohio, 45219

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State Medical Center

    Columbus, Ohio, 43210

  • Riverside Methodist

    Columbus, Ohio, 43214

  • Mercy Medical Center

    Coon Rapids, Minnesota, 55433

  • HCA Medical City Dallas

    Dallas, Texas, 75243

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Mercy Medical Center

    Des Moines, Iowa, 50266

  • Duke University

    Durham, North Carolina, 27705

  • Inova Fairfax Medical

    Falls Church, Virginia, 22042

  • HealthPark Medical Center

    Fort Myers, Florida, 33908

  • University of Florida Hospital

    Gainesville, Florida, 32610

  • Corewell Health

    Grand Rapids, Michigan, 49503

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • UPMC Pinnacle

    Harrisburg, Pennsylvania, 17050

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Heart Center Research / Huntsville Hospital

    Huntsville, Alabama, 35801

  • Portneuf Medical Center

    Idaho Falls, Idaho, 83404

  • Franciscan

    Indianapolis, Indiana, 46237

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52245

  • Jackson Madison County General

    Jackson, Tennessee, 38301

  • Baptist Health Jacksonville

    Jacksonville, Florida, 32207

  • St. Bernard's Heart & Vascular

    Jonesboro, Arkansas, 72401

  • St. Luke's Hospital

    Kansas City, Kansas, 64111

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Midwest Heart and Vascular (HCA)

    Kansas City, Missouri, 64132

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Baptist Health

    Lexington, Kentucky, 40503

  • University of Kentucky

    Lexington, Kentucky, 40536

  • CHI St. Vincent

    Little Rock, Arkansas, 72205

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Memorial Care Long Beach Medical Center

    Long Beach, California, 90806

  • Keck Medical Center of USC

    Los Angeles, California, 90033

  • Norton Healthcare

    Louisville, Kentucky, 40202

  • University of Louisville Health / Jewish Hospital

    Louisville, Kentucky, 40202

  • Novant Presbyterian Hospital

    Louisville, Kentucky, 40205

  • North Shore University Hospital (Northwell)

    Manhasset, New York, 11030

  • Wellstar - Kennestone

    Marietta, Georgia, 30060

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Baptist Health South Florida

    Miami, Florida, 33176

  • Abbott Northwestern / Minneapolis Heart

    Minneapolis, Minnesota, 55407

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Centennial Medical Center (TriStar)

    Nashville, Tennessee, 37203

  • Ascension St. Thomas West

    Nashville, Tennessee, 37205

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Sentara Hospitals & Sentara Medical Group

    Norfolk, Virginia, 23507

  • Nebraska Methodist

    Omaha, Nebraska, 68114

  • The Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Orlando Regional Medical Center

    Orlando, Florida, 32806

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC Health System

    Pittsburgh, Pennsylvania, 15232

  • Baylor Heart Hospital - Plano

    Plano, Texas, 75093

  • WakeMed Health & Hospitals

    Raleigh, North Carolina, 27610

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Corewell Health East

    Royal Oak, Michigan, 48073

  • Sutter Sacramento Hospital

    Sacramento, California, 95816

  • University of Utah

    Salt Lake City, Utah, 84132

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • HonorHealth Shea Scottsdale Healthcare

    Scottsdale, Arizona, 85258

  • Swedish Heart and Vascular Research

    Seattle, Washington, 98122

  • Sanford USD Medical Center

    Sioux Falls, South Dakota, 57105

  • Memorial Hospital (SIU Medicine)

    Springfield, Illinois, 62702

  • St. Lukes Hospital

    St Louis, Missouri, 63017

  • Washington University

    St Louis, Missouri, 63110

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141

  • Stanford University

    Stanford, California, 94305

  • St. Joseph Hospital

    Syracuse, New York, 13203

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Baycare Health System

    Tampa, Florida, 33607

  • The Toledo Hospital (Promedica)

    Toledo, Ohio, 43606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Trinity Mother Frances (CHRISTUS)

    Tyler, Texas, 75702

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Aspirus Hospital

    Wausau, Wisconsin, 54401

  • Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • Trinity Health (formerly St. Joseph Mercy)

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada14 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Queen Elizabeth II - Nova Scotia Health

    Halifax, Nova Scotia, B3H 3A7

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H1T 1C8

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W7

  • Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • IUCPQ Hosptial Laval

    Québec, G1V 4G5

  • New Brunswick Heart Centre

    Saint John, New Brunswick, E2L 4L2

  • St Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Germany6 sites

  • Rhön-Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale, Bavaria, 97616

  • Bad Rothefelde Schüchtermann-Klinik

    Bad Rothenfelde, Lower Saxony, 49 49214

  • Deutsches Herzzentrum der Charité

    Berlin, Brandenburg, 13353

  • University Heart Venter Freiburg Bad Krozingen

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • University Heart and Vascular Center Hamburg

    Hamburg, 20246

  • Albertinen Krankenhaus

    Hamburg, 22457

Other trials in Germany

United Kingdom5 sites

  • Royal Papworth Hospital

    Cambridge, CB2 0AY

  • St. Bartholomew's Hospital

    London, Greater London, EC1A 7BE

  • The James Cook University Hospital

    Middlesbrough, North Yorkshire, TS4 3BW

  • Northern General Hospital

    Sheffield, Great Britain, S5 7AU

  • The Royal Wolverhampton NHS Trust

    Wolverhampton, West Midlands, WV10 0QP

Other trials in United Kingdom

Australia3 sites

  • Victorian Heart Hospital and Monash University

    Clayton, Victoria, 3168

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Gold Coast University Hospital

    Southport, Queensland, 4215

Other trials in Australia

Austria2 sites

  • Medical University Hospital Graz

    Graz, Styria, 8036

  • Medical University Vienna

    Vienna, 1090

Other trials in Austria

Belgium2 sites

  • UZ Brussels

    Jette, Brussels Capital, 1090

  • University Hospitals UZ Leuven

    Leuven, Brabant, 3000

Other trials in Belgium

Spain2 sites

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Clinico San Carlos

    Madrid, 28040

Other trials in Spain

Czechia1 site

  • CKTCH Brno

    Brno, 602 00

Other trials in Czechia

New Zealand1 site

  • Waikato Hospital-Hamilton

    Hamilton, Waikato Region, 3240

Other trials in New Zealand

About this study

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.

Being tested
AtriClip LAA Exclusion System
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtriClip LAA Exclusion SystemDevice

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

Study groups in NCT05478304
Study groupRoleWhat they receive
TreatmentExperimentalLAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
Receives: Device: AtriClip LAA Exclusion System
ControlNo interventionNo LAAE concomitant to and at the time of planned cardiac surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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

    Measured: 30 days post index procedure

Secondary outcomes (1)

  1. Powered Secondary Effectiveness endpoint

    Time to the first occurrence of ischemic stroke or systemic arterial embolism

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study start25 Jan 2023
  3. Primary completionDec 2031 (estimated)
  4. Study completionApr 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
6,573 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05478304
Sponsor's protocol ID
CP-2021-05
Acronym
LeAAPS
Status last verified
Mar 2026
First submitted
15 Jul 2022
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 39395566

Questions about this trial

What is this clinical trial studying?

A study testing AtriClip LAA Exclusion System in people with Ischemic Stroke and Systemic Embolism, run by AtriCure, Inc. at 138 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Canada, Germany, United Kingdom, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint (time frame: Common termination point (median follow-up for 5 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05478304, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

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