RECRUITING

The Fourth Left Atrial Appendage Occlusion Study

Conditions

Atrial Fibrillation Stroke, Ischemic Systemic Embolism WATCHMAN Left Atrial Appendage (LAA)LAA Device Left Atrial Appendage Occlusion

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-30

Study Completion:2029-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05963698

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Program Director

CONTACT

905-521-2100

LAAOS-4@phri.ca

Principal Investigator

Jeff Healey

PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Study Locations (Sites)

Affinity Hospital dba Grandview Medical Center

Birmingham, Alabama, 35243

United States

Arrhythmia Research Group

Jonesboro, Arkansas, 72401

United States

MercyOne Iowa Heart Center

West Des Moines, Iowa, 50266

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

NYU Grossman School of Medicine

New York, New York, 10016

United States

Aultman Hospital

Canton, Ohio, 44710

United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705

United States

CHRISTUS Northeast Texas Health System

Tyler, Texas, 75701-2263

United States

Collaborators and Investigators

Sponsor: Hamilton Health Sciences Corporation

Jeff Healey, PRINCIPAL_INVESTIGATOR, Hamilton Health Sciences Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-30

Study Completion Date2029-12-01

Study Record Updates

Study Start Date2023-11-30

Study Completion Date2029-12-01

Terms related to this study

Keywords Provided by Researchers

WATCHMAN
Left Atrial Appendage (LAA)
LAA Device
Left Atrial Appendage Occlusion

Additional Relevant MeSH Terms

Atrial Fibrillation
Stroke, Ischemic
Systemic Embolism