Tests a heart device that closes the left atrial appendage to prevent stroke
Tests a device closing a heart pouch in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: The Fourth Left Atrial Appendage Occlusion Study
Key facts
- Where
- Albuquerque, Ann Arbor, Asheville, Atlanta, Atlantis, Austin, Baltimore, Birmingham, Boise, Brentwood, Burlington, Canton, Charlottesville, Cincinnati, Cleveland, Coeur d'Alene, Dallas, Detroit, Evanston, Fountain Valley, Hackensack, Hershey, Indianapolis, Jacksonville, Jonesboro, Kansas City, Largo, Lexington, Loma Linda, Los Angeles, Manhasset, Memphis, Milwaukee, New Orleans, New York, Ocala, Pasadena, Philadelphia, Pittsburgh, Providence, Rochester, Rock Island, Sacramento, St Louis, Tacoma, Tampa, The Woodlands, Tulsa, Tyler, West Des Moines, and Wilmington, United StatesSee the 53 sites
Where in United States
- Presbyterian Healthcare Services d.b.a. Presbyterian Heart GroupAlbuquerque, United StatesTaking people
- University of MichiganAnn Arbor, United StatesTaking people
- Mission Hospital HCAAsheville, United StatesTaking people
- Emory UniversityAtlanta, United StatesTaking people
- JFK Medical Center Limited Partnership d/b/a HCA Florida JFK HospitalAtlantis, United StatesNo longer taking part
- Texas Cardiac Arrhythmia Research FoundationAustin, United StatesNo longer taking part
- University of Maryland, BaltimoreBaltimore, United StatesTaking people
- Affinity Hospital dba Grandview Medical CenterBirmingham, United StatesNo longer taking part
- St Luke's Regional Medical Center, LtdBoise, United StatesTaking people
- Glanecare, Inc. d/b/a HCA Florida Brandon HospitalBrentwood, United StatesNo longer taking part
- Lahey Clinic, IncBurlington, United StatesTaking people
- Aultman HospitalCanton, United StatesTaking people
- The Rector and Visitors of the University of VirginiaCharlottesville, United StatesTaking people
- TriHealth Inc.Cincinnati, United StatesTaking people
- University of CincinnatiCincinnati, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- Kootenai Health Inc.Coeur d'Alene, United StatesTaking people
- Baylor Research InstituteDallas, United StatesTaking people
- Henry Ford Health SystemDetroit, United StatesTaking people
- Northwestern UniversityEvanston, United StatesTaking people
- Memorial Health ServicesFountain Valley, United StatesTaking people
- Hackensack University Medical CenterHackensack, United StatesTaking people
- The Pennsylvania State University and The Milton S. Hershey Medical CenterHershey, United StatesTaking people
- Community Health Network, IncIndianapolis, United StatesTaking people
- St. Vincent's Health SystemJacksonville, United StatesNo longer taking part
- Arrhythmia Research GroupJonesboro, United StatesTaking people
- University of Kansas Medical Center Research Institute, IncKansas City, United StatesTaking people
- Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical CenterLargo, United StatesNo longer taking part
- Babtist Health LexingtonLexington, United StatesTaking people
- Loma Linda University HealthLoma Linda, United StatesNo longer taking part
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
- The Feinstein Institutes for Medical ResearchManhasset, United StatesNo longer taking part
- The University of TennesseeMemphis, United StatesTaking people
- The Medical College of WisconsinMilwaukee, United StatesTaking people
- Ochsner Clinic FoundationNew Orleans, United StatesTaking people
- Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College and The New York Presbyterian HospitalNew York, United StatesTaking people
- NYU Grossman School of MedicineNew York, United StatesNo longer taking part
- HCA Florida Ocala HospitalOcala, United StatesNo longer taking part
- Southern California Permanente Medical GroupPasadena, United StatesTaking people
- The Trustees of the University of PennsylvaniaPhiladelphia, United StatesTaking people
- University of Pittsburgh Medical Center (UPMC) Presbyterian Heart and Vascular InstitutePittsburgh, United StatesTaking people
- Rhode Island HospitalProvidence, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- Cardiovascular Medicine, PLLC and Unity Point Trinity Rock IslandRock Island, United StatesTaking people
- Sutter Valley Hospitals dba Sutter Institute for Medical ResearchSacramento, United StatesTaking people
- St Louis UniversitySt Louis, United StatesTaking people
- CommonSpirit Health Research InstituteTacoma, United StatesTaking people
- The University of South FloridaTampa, United StatesTaking people
- Heart Rhythm AssociatesThe Woodlands, United StatesNo longer taking part
- Saint Francis HospitalTulsa, United StatesTaking people
- CHRISTUS Northeast Texas Health SystemTyler, United StatesTaking people
- MercyOne Iowa Heart CenterWest Des Moines, United StatesTaking people
- Christiana Care Health Services, Inc.Wilmington, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hamilton Health Sciences Corporation
- Trial code
- NCT05963698
- Record updated
- 18 September 2026
- Original description
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.Read full original descriptionShow less
The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4)
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
Inclusion: (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism; Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. [Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).]; Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan to discontinue treatment with oral anticoagulants for the expected duration of the trial.
Exclusion: Prior left atrial appendage occlusion or removal (surgical or percutaneous); Prior percutaneous atrial septal defect or patent foramen ovale closure; Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation; Individuals being treated with direct thrombin inhibitors; Age < 18 years; Anticipated life-expectancy of < 2 years; Current left atrial appendage thrombus; Planned atrial fibrillation ablation within 90 days of enrollment; Women of childbearing potential unless they agree to employ effective birth control methods throughout the study; Patient unable or willing to give informed consent.