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The Fourth Left Atrial Appendage Occlusion Study | Clinical Trials | Clareo Health

RECRUITINGNA

The Fourth Left Atrial Appendage Occlusion Study

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

NCT05963698•Hamilton Health Sciences Corporation

Summary

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (127)

Affinity Hospital dba Grandview Medical Center

Birmingham, Alabama, United States

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Memorial Health Services

Fountain Valley, California, United States

Loma Linda University Health

Loma Linda, California, United States

Southern California Permanente Medical Group

Pasadena, California, United States

Sutter Valley Hospitals dba Sutter Institute for Medical Research

Sacramento, California, United States

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

Atlantis, Florida, United States

St. Vincent's Health System

Jacksonville, Florida, United States

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

Largo, Florida, United States

The University of South Florida

Tampa, Florida, United States

Key Dates

Start Date

November 30, 2023

Primary Completion Date

September 1, 2029

Completion Date

December 1, 2029

Last Updated

March 12, 2026

Enrollment

4,000

ESTIMATED participants

Conditions

Atrial FibrillationStroke, IschemicSystemic Embolism

Interventions

WATCHMAN device

DEVICE

Contacts

Program Director

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Fourth Left Atrial Appendage Occlusion Study

Inclusion Criteria

Exclusion Criteria

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