The Fourth Left Atrial Appendage Occlusion Study
Recruiting · NCT05963698 · Interventional (participants receive a specific treatment) · Lead sponsor: Hamilton Health Sciences Corporation
View the official record on ClinicalTrials.gov →Interventions studied
WATCHMAN device
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- (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 criteria
- Age \< 18 years
- Current left atrial appendage thrombus
- 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
- Planned atrial fibrillation ablation within 90 days of enrollment
- Individuals being treated with direct thrombin inhibitors
- Women of childbearing potential unless they agree to employ effective birth control methods throughout the study
- Anticipated life-expectancy of \< 2 years
- Patient unable or willing to give informed consent
Where it is running
60 locations listed across 29 US states.
- Affinity Hospital dba Grandview Medical Center - Birmingham, Alabama, United States
- Arrhythmia Research Group - Jonesboro, Arkansas, United States
- Memorial Health Services - Fountain Valley, California, United States
- Loma Linda University Health - Loma Linda, California, United States
- Southern California Permanente Medical Group - Pasadena, California, United States
- Sutter Valley Hospitals dba Sutter Institute for Medical Research - Sacramento, California, United States
- JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital - Atlantis, Florida, United States
- St. Vincent's Health System - Jacksonville, Florida, United States
- Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center - Largo, Florida, United States
- HCA Florida Ocala Hospital - Ocala, Florida, United States
- The University of South Florida - Tampa, Florida, United States
- Emory University - Atlanta, Georgia, United States
- St Luke's Regional Medical Center, Ltd - Boise, Idaho, United States
- Kootenai Health Inc. - Coeur d'Alene, Idaho, United States
- Northwestern University - Evanston, Illinois, United States
- Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island - Rock Island, Illinois, United States
- Community Health Network Inc. - Indianapolis, Indiana, United States
- MercyOne Iowa Heart Center - West Des Moines, Iowa, United States
- University of Kansas Medical Center Research Institute, Inc. - Kansas City, Kansas, United States
- Babtist Health Lexington - Lexington, Kentucky, United States
- Ochsner Clinic Foundation - New Orleans, Louisiana, United States
- University of Maryland Baltimore - Baltimore, Maryland, United States
- Lahey Clinic Inc. - Burlington, Massachusetts, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Henry Ford Health System - Detroit, Michigan, United States
- Henry Ford Health System - Detroit, Michigan, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Hackensack University Medical Center - Hackensack, New Jersey, United States
- Presbyterian Healthcare Services d.b.a. Presbyterian Heart Group - Albuquerque, New Mexico, United States
- The Feinstein Institutes for Medical Research - Manhasset, New York, United States
- Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College and The New York Presbyterian Hospital - New York, New York, United States
- NYU Grossman School of Medicine - New York, New York, United States
- Mission Hospital HCA - Asheville, North Carolina, United States
- Aultman Hospital - Canton, Ohio, United States
- TriHealth Inc. - Cincinnati, Ohio, United States
- University of Cincinnati - Cincinnati, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Saint Francis Hospital - Tulsa, Oklahoma, United States
- The Pennsylvania State University and The Milton S. Hershey Medical Center - Hershey, Pennsylvania, United States
- The Trustees of the University of Pennsylvania - Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center (UPMC) Presbyterian Heart and Vascular Institute - Pittsburgh, Pennsylvania, United States
- Rhode Island Hospital - Providence, Rhode Island, United States
- Glanecare, Inc. d/b/a HCA Florida Brandon Hospital - Brentwood, Tennessee, United States
- The University of Tennessee - Memphis, Tennessee, United States
- Texas Cardiac Arrhythmia Research Foundation - Austin, Texas, United States
- Baylor Research Institute - Dallas, Texas, United States
- Heart Rhythm Associates - The Woodlands, Texas, United States
- CHRISTUS Northeast Texas Health System - Tyler, Texas, United States
- The Rector and Visitors of the University of Virginia - Charlottesville, Virginia, United States
- CommonSpirit Health Research Institute - Tacoma, Washington, United States
- The Medical College of Wisconsin - Milwaukee, Wisconsin, United States
- University General Hospital Dr. Balmis - Alicante, Spain
- Charité Universitätsmedizin Berlin - Berlin, Germany
- Charité - Universitätsmedizin Berlin - Berlin, Germany
- Fondazione Poliambulanza Istituto Ospedaliero - Brescia, Italy
- Universitair Ziekenhuis Brussel - Brussels, Belgium
- Rigshospitalet (RH) - Copenhagen, Denmark
- Asklepios Kliniken Hamburg GmbH - Hamburg, Germany
- Asklepios Kliniken Hamburg GmbH - Hamburg, Germany
- Universitätsklinikum Hamburg-Eppendorf (UKE) - Hamburg, Germany
Showing 60 of 140 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →