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Clinical Trials in Denmark / NCT05963698
Recruiting Not applicable

The Fourth Left Atrial Appendage Occlusion Study

NCT05963698 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2023-11-30
Last updated
2026-09-18

Condition(s) studied

Atrial FibrillationStroke, IschemicSystemic Embolism

Investigational drug(s) / intervention(s)

WATCHMAN device

WATCHMAN device: Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (150)

FacilityCityRegionStatus
Affinity Hospital dba Grandview Medical Center Birmingham Alabama Withdrawn
Arrhythmia Research Group Jonesboro Arkansas Recruiting
Memorial Health Services Fountain Valley California Recruiting
Loma Linda University Health Loma Linda California Withdrawn
Cedars-Sinai Medical Center Los Angeles California Recruiting
Southern California Permanente Medical Group Pasadena California Recruiting
Sutter Valley Hospitals dba Sutter Institute for Medical Research Sacramento California Recruiting
Christiana Care Health Services, Inc. Wilmington Delaware Recruiting
JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital Atlantis Florida Withdrawn
St. Vincent's Health System Jacksonville Florida Withdrawn
Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center Largo Florida Withdrawn
HCA Florida Ocala Hospital Ocala Florida Withdrawn
The University of South Florida Tampa Florida Recruiting
Emory University Atlanta Georgia Recruiting
St Luke's Regional Medical Center, Ltd Boise Idaho Recruiting
Kootenai Health Inc. Coeur d'Alene Idaho Recruiting
Northwestern University Evanston Illinois Recruiting
Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island Rock Island Illinois Recruiting
Community Health Network Inc. Indianapolis Indiana Recruiting
MercyOne Iowa Heart Center West Des Moines Iowa Recruiting
University of Kansas Medical Center Research Institute, Inc. Kansas City Kansas Recruiting
Babtist Health Lexington Lexington Kentucky Recruiting
Ochsner Clinic Foundation New Orleans Louisiana Recruiting
University of Maryland Baltimore Baltimore Maryland Recruiting
Lahey Clinic Inc. Burlington Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Henry Ford Health System Detroit Michigan Recruiting
Henry Ford Health System Detroit Michigan Recruiting
Mayo Clinic Rochester Minnesota Recruiting
St. Louis University, St Louis Missouri Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Presbyterian Healthcare Services d.b.a. Presbyterian Heart Group Albuquerque New Mexico Recruiting
The Feinstein Institutes for Medical Research Manhasset New York Withdrawn
Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College and The New York Presbyterian Hospital New York New York Recruiting
NYU Grossman School of Medicine New York New York Withdrawn
Mission Hospital HCA Asheville North Carolina Recruiting
Aultman Hospital Canton Ohio Recruiting
TriHealth Inc. Cincinnati Ohio Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
Cleveland Clinic Cleveland Ohio Recruiting

+ 110 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05963698 on ClinicalTrials.gov ↗ ← All trials in Denmark