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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

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, Arkansas 72401

Memorial Health Services
Fountain Valley, California 92708

Loma Linda University Health
Loma Linda, California 92354

Southern California Permanente Medical Group
Pasadena, California 91101

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

JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital
Atlantis, Florida 33462

St. Vincent's Health System
Jacksonville, Florida 32204

Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center
Largo, Florida 33770

HCA Florida Ocala Hospital
Ocala, Florida 34471

The University of South Florida
Tampa, Florida 33620

Emory University
Atlanta, Georgia 30322

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

Kootenai Health Inc.
Coeur d'Alene, Idaho 83814

Northwestern University
Evanston, Illinois 60208

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

Community Health Network Inc.
Indianapolis, Indiana 46256

MercyOne Iowa Heart Center
West Des Moines, Iowa 50266

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

Babtist Health Lexington
Lexington, Kentucky 40503

Ochsner Clinic Foundation
New Orleans, Louisiana 70121

University of Maryland Baltimore
Baltimore, Maryland 21201

Lahey Clinic Inc.
Burlington, Massachusetts 01805

University of Michigan
Ann Arbor, Michigan 48109

Henry Ford Health System
Detroit, Michigan 48202

Henry Ford Health System
Detroit, Michigan 48202

Mayo Clinic
Rochester, Minnesota 55905

Hackensack University Medical Center
Hackensack, New Jersey 07601

Presbyterian Healthcare Services d.b.a. Presbyterian Heart Group
Albuquerque, New Mexico 87106

The Feinstein Institutes for Medical Research
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

Mission Hospital HCA
Asheville, North Carolina 28801

Aultman Hospital
Canton, Ohio 44710

TriHealth Inc.
Cincinnati, Ohio 45202

University of Cincinnati
Cincinnati, Ohio 45221

Cleveland Clinic
Cleveland, Ohio 44195

Saint Francis Hospital
Tulsa, Oklahoma 74136

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

The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania 19104

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

Rhode Island Hospital
Providence, Rhode Island 02903

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

The University of Tennessee
Memphis, Tennessee 38163

Baylor Research Institute
Dallas, Texas 75204

CHRISTUS Northeast Texas Health System
Tyler, Texas 75701-2263

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

CommonSpirit Health Research Institute
Tacoma, Washington 98405

The Medical College of Wisconsin
Milwaukee, Wisconsin 53226

More Details

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.