The Fourth Left Atrial Appendage Occlusion Study

Description

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

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Study Overview

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Study Details

Study overview

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.

The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4)

The Fourth Left Atrial Appendage Occlusion Study

Condition
Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Birmingham

Affinity Hospital dba Grandview Medical Center, Birmingham, Alabama, United States, 35243

Jonesboro

Arrhythmia Research Group, Jonesboro, Arkansas, United States, 72401

West Des Moines

MercyOne Iowa Heart Center, West Des Moines, Iowa, United States, 50266

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

New York

NYU Grossman School of Medicine, New York, New York, United States, 10016

Canton

Aultman Hospital, Canton, Ohio, United States, 44710

Austin

Texas Cardiac Arrhythmia Research Foundation, Austin, Texas, United States, 78705

Tyler

CHRISTUS Northeast Texas Health System, Tyler, Texas, United States, 75701-2263

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hamilton Health Sciences Corporation,

Jeff Healey, PRINCIPAL_INVESTIGATOR, Hamilton Health Sciences Corporation

Study Record Dates

2029-12-01