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

  1. (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

  1. 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

ArmDescriptionAssigned Intervention
Experimental
WATCHMAN device 		Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
  • Device: 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 4116834, Arkansas 4099753 72401

Memorial Health Services
Fountain Valley 5350207, California 5332921 92708

Loma Linda University Health
Loma Linda 5367696, California 5332921 92354

Sutter Valley Hospitals dba Sutter Institute for Medical Research
Sacramento 5389489, California 5332921 95816

St. Vincent's Health System
Jacksonville 4160021, Florida 4155751 32204

The University of South Florida
Tampa 4174757, Florida 4155751 33620

Emory University
Atlanta 4180439, Georgia 4197000 30322

St Luke's Regional Medical Center, Ltd
Boise 5586437, Idaho 5596512 83712

Kootenai Health Inc.
Coeur d'Alene 5589173, Idaho 5596512 83814

Northwestern University
Evanston 4891382, Illinois 4896861 60208

Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island
Rock Island 4907907, Illinois 4896861 61201

Community Health Network Inc.
Indianapolis 4259418, Indiana 4921868 46256

MercyOne Iowa Heart Center
West Des Moines 4881346, Iowa 4862182 50266

University of Kansas Medical Center Research Institute, Inc.
Kansas City 4273837, Kansas 4273857 66160

Babtist Health Lexington
Lexington 4297983, Kentucky 6254925 40503

Ochsner Clinic Foundation
New Orleans 4335045, Louisiana 4331987 70121

University of Maryland Baltimore
Baltimore 4347778, Maryland 4361885 21201

Lahey Clinic Inc.
Burlington 4931737, Massachusetts 6254926 01805

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905

The Feinstein Institutes for Medical Research
Manhasset 5125766, New York 5128638 11030

Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College and The New York Presbyterian Hospital
New York 5128581, New York 5128638 10065

Mission Hospital HCA
Asheville 4453066, North Carolina 4482348 28801

Aultman Hospital
Canton 5149222, Ohio 5165418 44710

TriHealth Inc.
Cincinnati 4508722, Ohio 5165418 45202

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195

The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033

The Trustees of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104

University of Pittsburgh Medical Center (UPMC) Presbyterian Heart and Vascular Institute
Pittsburgh 5206379, Pennsylvania 6254927 15213

Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903

Glanecare, Inc. d/b/a HCA Florida Brandon Hospital
Brentwood 4608408, Tennessee 4662168 37027

Baylor Research Institute
Dallas 4684888, Texas 4736286 75204

CHRISTUS Northeast Texas Health System
Tyler 4738214, Texas 4736286 75701-2263

The Rector and Visitors of the University of Virginia
Charlottesville 4752031, Virginia 6254928 22903

CommonSpirit Health Research Institute
Tacoma 5812944, Washington 5815135 98405

The Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226

More Details

NCT ID
NCT05963698
Status
Recruiting
Sponsor
Hamilton Health Sciences Corporation

Study Contact

Program Director
905-521-2100
LAAOS-4@phri.ca

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.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center