Recruiting NCT05963698

The Fourth Left Atrial Appendage Occlusion Study

No phase Interventional Atrial Fibrillation Stroke, Ischemic Systemic Embolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: WATCHMAN device.
Who it may be relevant to: Registry conditions: Atrial Fibrillation, Stroke, Ischemic, Systemic Embolism. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Belgium, Canada, Denmark, France +7
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Interventions

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

Primary outcome measures

Ischemic stroke or systemic embolism [Time frame: The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]

Secondary outcome measures (6)

All-cause stroke or systemic embolism [Time frame: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]
All-cause stroke, systemic embolism, or transient ischemic attack (TIA) [Time frame: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]
Montreal Cognitive Assessment (MoCA) Score [Time frame: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]
New disabling ischemic strokes [Time frame: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]
Cardiovascular mortality [Time frame: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]
All-cause mortality [Time frame: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]

Eligibility criteria

Inclusion criteria

(a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism
Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. \[Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).\]
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

Age < 18 years
Current left atrial appendage thrombus
Prior left atrial appendage occlusion or removal (surgical or percutaneous)
Prior percutaneous atrial septal defect or patent foramen ovale closure
Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation
Planned atrial fibrillation ablation within 90 days of enrollment
Individuals being treated with direct thrombin inhibitors
Women of childbearing potential unless they agree to employ effective birth control methods throughout the study
Anticipated life-expectancy of < 2 years
Patient unable or willing to give informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Treatment

Study locations

United States · 51 centers

Affinity Hospital dba Grandview Medical Center — Birmingham
Arrhythmia Research Group — Jonesboro
Memorial Health Services — Fountain Valley
Loma Linda University Health — Loma Linda
Southern California Permanente Medical Group — Pasadena
Sutter Valley Hospitals dba Sutter Institute for Medical Research — Sacramento
JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital — Atlantis
St. Vincent's Health System — Jacksonville
… and 43 more centers

Canada · 24 centers

University of Calgary — Calgary
Vancouver Coastal Health Authority — Vancouver
St. Boniface Hospital Inc. — Winnipeg
Circulate Cardiac & Vascular Centre (CCVC) — Burlington
Cambridge Cardiac Care Inc. — Cambridge
Hamilton Health Sciences Corp — Hamilton
Research St. Joseph's - Hamilton — Hamilton
Waterloo Wellington Cardiovascular Research Institute (WWCRI) — Kitchener
… and 16 more centers

Germany · 18 centers