The Fourth Left Atrial Appendage Occlusion Study
Purpose
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.
Conditions
- Atrial Fibrillation
- Stroke, Ischemic
- Systemic Embolism
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism 2. 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).] 3. 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 2. Current left atrial appendage thrombus 3. Prior left atrial appendage occlusion or removal (surgical or percutaneous) 4. Prior percutaneous atrial septal defect or patent foramen ovale closure 5. Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation 6. Planned atrial fibrillation ablation within 90 days of enrollment 7. Individuals being treated with direct thrombin inhibitors 8. Women of childbearing potential unless they agree to employ effective birth control methods throughout the study 9. Anticipated life-expectancy of < 2 years 10. Patient unable or willing to give informed consent
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized Controlled Trial
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Events Adjudication Committee is blinded to intervention assignment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental WATCHMAN device |
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device |
|
|
No Intervention Standard Care |
Participants will receive local, standard medical care |
|
Recruiting Locations
Arrhythmia Research Group
Jonesboro, Arkansas 72401
Jonesboro, Arkansas 72401
Memorial Health Services
Fountain Valley, California 92708
Fountain Valley, California 92708
Loma Linda University Health
Loma Linda, California 92354
Loma Linda, California 92354
Southern California Permanente Medical Group
Pasadena, California 91101
Pasadena, California 91101
Sutter Valley Hospitals dba Sutter Institute for Medical Research
Sacramento, California 95816
Sacramento, California 95816
JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital
Atlantis, Florida 33462
Atlantis, Florida 33462
St. Vincent's Health System
Jacksonville, Florida 32204
Jacksonville, Florida 32204
Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center
Largo, Florida 33770
Largo, Florida 33770
HCA Florida Ocala Hospital
Ocala, Florida 34471
Ocala, Florida 34471
The University of South Florida
Tampa, Florida 33620
Tampa, Florida 33620
Emory University
Atlanta, Georgia 30322
Atlanta, Georgia 30322
St Luke's Regional Medical Center, Ltd
Boise, Idaho 83712
Boise, Idaho 83712
Kootenai Health Inc.
Coeur d'Alene, Idaho 83814
Coeur d'Alene, Idaho 83814
Northwestern University
Evanston, Illinois 60208
Evanston, Illinois 60208
Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island
Rock Island, Illinois 61201
Rock Island, Illinois 61201
Community Health Network Inc.
Indianapolis, Indiana 46256
Indianapolis, Indiana 46256
MercyOne Iowa Heart Center
West Des Moines, Iowa 50266
West Des Moines, Iowa 50266
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Babtist Health Lexington
Lexington, Kentucky 40503
Lexington, Kentucky 40503
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
University of Maryland Baltimore
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Lahey Clinic Inc.
Burlington, Massachusetts 01805
Burlington, Massachusetts 01805
University of Michigan
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Henry Ford Health System
Detroit, Michigan 48202
Detroit, Michigan 48202
Henry Ford Health System
Detroit, Michigan 48202
Detroit, Michigan 48202
Mayo Clinic
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Presbyterian Healthcare Services d.b.a. Presbyterian Heart Group
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87106
The Feinstein Institutes for Medical Research
Manhasset, New York 11030
Manhasset, New York 11030
Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College and The New York Presbyterian Hospital
New York, New York 10065
New York, New York 10065
Mission Hospital HCA
Asheville, North Carolina 28801
Asheville, North Carolina 28801
Aultman Hospital
Canton, Ohio 44710
Canton, Ohio 44710
TriHealth Inc.
Cincinnati, Ohio 45202
Cincinnati, Ohio 45202
University of Cincinnati
Cincinnati, Ohio 45221
Cincinnati, Ohio 45221
Cleveland Clinic
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Saint Francis Hospital
Tulsa, Oklahoma 74136
Tulsa, Oklahoma 74136
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
University of Pittsburgh Medical Center (UPMC) Presbyterian Heart and Vascular Institute
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Rhode Island Hospital
Providence, Rhode Island 02903
Providence, Rhode Island 02903
Glanecare, Inc. d/b/a HCA Florida Brandon Hospital
Brentwood, Tennessee 37027
Brentwood, Tennessee 37027
The University of Tennessee
Memphis, Tennessee 38163
Memphis, Tennessee 38163
Baylor Research Institute
Dallas, Texas 75204
Dallas, Texas 75204
CHRISTUS Northeast Texas Health System
Tyler, Texas 75701-2263
Tyler, Texas 75701-2263
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
CommonSpirit Health Research Institute
Tacoma, Washington 98405
Tacoma, Washington 98405
The Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- Status
- Recruiting
- Sponsor
- Hamilton Health Sciences Corporation
Detailed Description
LAAOS-4 is a multicentre, prospective, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE) 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.