Heart pouch closure during surgery may slash stroke risk

NCT ID NCT05478304

Prevention Sponsor: AtriCure, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether closing a small pouch in the heart (the left atrial appendage) during heart surgery can prevent strokes and blood clots. About 6,500 adults at risk for atrial fibrillation and stroke are taking part. The goal is to see if this simple addition to surgery is safe and effective at reducing future strokes.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

6,573 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Apr 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ischemic stroke prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke Systemic embolism

Contacts and locations

Locations

Abbott Northwestern / Minneapolis Heart

Minneapolis, Minnesota, 55407, United States
Albertinen Krankenhaus

Hamburg, 22457, Germany
Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States
Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States
Ascension St. Thomas West

Nashville, Tennessee, 37205, United States
Ascension St. Vincent

Carmel, Indiana, 46290, United States
Aspirus Hospital

Wausau, Wisconsin, 54401, United States
Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States
Bad Rothefelde Schüchtermann-Klinik

Bad Rothenfelde, Lower Saxony, 49 49214, Germany
Baptist Health

Lexington, Kentucky, 40503, United States
Baptist Health Jacksonville

Jacksonville, Florida, 32207, United States
Baptist Health South Florida

Miami, Florida, 33176, United States
Baycare Health System

Tampa, Florida, 33607, United States
Baylor Heart Hospital - Plano

Plano, Texas, 75093, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
CHI St. Vincent

Little Rock, Arkansas, 72205, United States
CKTCH Brno

Brno, 602 00, Czechia
Centennial Medical Center (TriStar)

Nashville, Tennessee, 37203, United States
Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H1T 1C8, Canada
Charleston Area Medical Center (CAMC)

Charleston, West Virginia, 25301, United States
Christ Hospital / Lindner Research Center

Cincinnati, Ohio, 45219, United States
Christiana Care Health Services

Newark, Delaware, 19718, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Corewell Health

Grand Rapids, Michigan, 49503, United States
Corewell Health East

Royal Oak, Michigan, 48073, United States
Deutsches Herzzentrum der Charité

Berlin, Brandenburg, 13353, Germany
Duke University

Durham, North Carolina, 27705, United States
Emory University Hospital

Atlanta, Georgia, 30308, United States
Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada
Franciscan

Indianapolis, Indiana, 46237, United States
Gold Coast University Hospital

Southport, Queensland, 4215, Australia
HCA Florida JFK Hospital

Atlantis, Florida, 33462, United States
HCA Medical City Dallas

Dallas, Texas, 75243, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada
Hartford Hospital

Hartford, Connecticut, 06102, United States
HealthPark Medical Center

Fort Myers, Florida, 33908, United States
Heart Center Research / Huntsville Hospital

Huntsville, Alabama, 35801, United States
Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States
HonorHealth Shea Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States
Hospital Clinic Barcelona

Barcelona, 08036, Spain
Hospital Clinico San Carlos

Madrid, 28040, Spain
Houston Methodist Hospital

Houston, Texas, 77030, United States
IUCPQ Hosptial Laval

Québec, G1V 4G5, Canada
Inova Fairfax Medical

Falls Church, Virginia, 22042, United States
Jackson Madison County General

Jackson, Tennessee, 38301, United States
Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States
Kansas University Medical Center

Kansas City, Kansas, 66160, United States
Keck Medical Center of USC

Los Angeles, California, 90033, United States
Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada
Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States
Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States
Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States
London Health Sciences Centre

London, Ontario, N6A 5A5, Canada
Loyola University Medical Center

Maywood, Illinois, 60153, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Medical University Hospital Graz

Graz, Styria, 8036, Austria
Medical University Vienna

Vienna, 1090, Austria
Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States
Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Memorial Care Long Beach Medical Center

Long Beach, California, 90806, United States
Memorial Hospital (SIU Medicine)

Springfield, Illinois, 62702, United States
Memorial Regional Hospital

Hollywood, Florida, 33021, United States
Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States
Mercy Medical Center

Des Moines, Iowa, 50266, United States
Mercy Medical Center

Coon Rapids, Minnesota, 55433, United States
Midwest Heart and Vascular (HCA)

Kansas City, Missouri, 64132, United States
Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada
Munson Medical Center

Traverse City, Michigan, 49684, United States
Nebraska Methodist

Omaha, Nebraska, 68114, United States
New Brunswick Heart Centre

Saint John, New Brunswick, E2L 4L2, Canada
North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States
North Shore University Hospital (Northwell)

Manhasset, New York, 11030, United States
Northern General Hospital

Sheffield, Great Britain, S5 7AU, United Kingdom
Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States
Norton Healthcare

Louisville, Kentucky, 40202, United States
Novant Presbyterian Hospital

Louisville, Kentucky, 40205, United States
Ohio State Medical Center

Columbus, Ohio, 43210, United States
Orlando Regional Medical Center

Orlando, Florida, 32806, United States
Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada
Our Lady of the Lake Hospital

Baton Rouge, Louisiana, 70808, United States
Piedmont Hospital

Atlanta, Georgia, 30309, United States
Portneuf Medical Center

Idaho Falls, Idaho, 83404, United States
Queen Elizabeth II - Nova Scotia Health

Halifax, Nova Scotia, B3H 3A7, Canada
Rhön-Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, Bavaria, 97616, Germany
Riverside Methodist

Columbus, Ohio, 43214, United States
Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada
Royal Papworth Hospital

Cambridge, CB2 0AY, United Kingdom
Sanford USD Medical Center

Sioux Falls, South Dakota, 57105, United States
Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States
Sentara Hospitals & Sentara Medical Group

Norfolk, Virginia, 23507, United States
St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada
St. Bartholomew's Hospital

London, Greater London, EC1A 7BE, United Kingdom
St. Bernard's Heart & Vascular

Jonesboro, Arkansas, 72401, United States
St. Francis Hospital

Roslyn, New York, 11576, United States
St. Joseph Hospital

Syracuse, New York, 13203, United States
St. Luke's Hospital

Kansas City, Kansas, 64111, United States
St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States
St. Lukes Hospital

St Louis, Missouri, 63017, United States
St. Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia
Stanford University

Stanford, California, 94305, United States
Sutter Sacramento Hospital

Sacramento, California, 95816, United States
Swedish Heart and Vascular Research

Seattle, Washington, 98122, United States
Tampa General Hospital

Tampa, Florida, 33606, United States
The James Cook University Hospital

Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom
The Nebraska Medical Center

Omaha, Nebraska, 68198, United States
The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom
The Toledo Hospital (Promedica)

Toledo, Ohio, 43606, United States
Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada
TriHealth / Bethesda North Hospital

Cincinnati, Ohio, 45202, United States
Trinity Health (formerly St. Joseph Mercy)

Ypsilanti, Michigan, 48197, United States
Trinity Mother Frances (CHRISTUS)

Tyler, Texas, 75702, United States
UPMC Health System

Pittsburgh, Pennsylvania, 15232, United States
UPMC Pinnacle

Harrisburg, Pennsylvania, 17050, United States
UT Dell Medical School

Austin, Texas, 78705, United States
UZ Brussels

Jette, Brussels Capital, 1090, Belgium
University Heart Venter Freiburg Bad Krozingen

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
University Heart and Vascular Center Hamburg

Hamburg, 20246, Germany
University Hospitals UZ Leuven

Leuven, Brabant, 3000, Belgium
University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States
University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada
University of Colorado

Boulder, Colorado, 80309, United States
University of Florida Hospital

Gainesville, Florida, 32610, United States
University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52245, United States
University of Kentucky

Lexington, Kentucky, 40536, United States
University of Louisville Health / Jewish Hospital

Louisville, Kentucky, 40202, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Texas Southwestern

Dallas, Texas, 75390, United States
University of Utah

Salt Lake City, Utah, 84132, United States
Victorian Heart Hospital and Monash University

Clayton, Victoria, 3168, Australia
Waikato Hospital-Hamilton

Hamilton, Waikato Region, 3240, New Zealand
Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States
WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States
Washington University

St Louis, Missouri, 63110, United States
Wellstar - Kennestone

Marietta, Georgia, 30060, United States
West Virginia University

Morgantown, West Virginia, 26506, United States

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