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
Affinity Hospital dba Grandview Medical Center
Birmingham, Alabama 35243
Birmingham, Alabama 35243
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
Sutter Valley Hospitals dba Sutter Institute for Medical Research
Sacramento, California 95816
Sacramento, California 95816
St. Vincent's Health System
Jacksonville, Florida 32204
Jacksonville, Florida 32204
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
The Feinstein Institutes for Medical Research
Manhasset, New York 11030
Manhasset, New York 11030
NYU Grossman School of Medicine
New York, New York 10016
New York, New York 10016
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
Cleveland Clinic
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78705
Austin, Texas 78705
Baylor Research Institute
Dallas, Texas 75204
Dallas, Texas 75204
Heart Rhythm Associates
The Woodlands, Texas 77380
The Woodlands, Texas 77380
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
The Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- NCT ID
- NCT05963698
- 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.