Testing WATCHMAN device for atrial fibrillation
Official title: The Fourth Left Atrial Appendage Occlusion Study
The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4)
Interventions
WATCHMAN device
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
Canadian Sites (24)
University of Calgary
Calgary, Alberta, Canada
Vancouver Coastal Health Authority
Vancouver, British Columbia, Canada
St. Boniface Hospital Inc.
Winnipeg, Manitoba, Canada
Circulate Cardiac & Vascular Centre (CCVC)
Burlington, Ontario, Canada
Cambridge Cardiac Care Inc.
Cambridge, Ontario, Canada
Hamilton Health Sciences Corp
Hamilton, Ontario, Canada
Research St. Joseph's - Hamilton
Hamilton, Ontario, Canada
Waterloo Wellington Cardiovascular Research Institute (WWCRI)
Kitchener, Ontario, Canada
Lawson Health Research Institute
London, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Partners in Advanced Cardiac Evaluation (PACE)
Newmarket, Ontario, Canada
Ottawa Heart Institute Research Corp
Ottawa, Ontario, Canada
Niagara Health System - Niagara Falls
St. Catharines, Ontario, Canada
Niagara Health Systems - St. Catharines
St. Catharines, Ontario, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Lawrence Park Cardiology
Toronto, Ontario, Canada
Unity Health Toronto
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Institut de Cardiologie de Montreal (ICM)
Montreal, Quebec, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
Sherbrooke, Quebec, Canada
Prairie Valscular Research Inc. (PVRI)
Regina, Saskatchewan, Canada
Saskatchewan Health Authority
Saskatoon, Saskatchewan, Canada
Eligibility Criteria
See who this study is looking for13 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. \[Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).\]
- +(a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism
- +Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →, AND no documented plan to discontinue treatment with oral anticoagulants for the expected duration of the trial.
Exclusion
- −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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- −Individuals being treated with direct thrombin inhibitors
- −Anticipated life-expectancy of \< 2 years
- −Patient unable or willing to give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Women of childbearing potential unless they agree to employ effective birth controlControl groupThe group a new treatment is measured against.Read more → methods throughout the study
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: WATCHMAN device.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 4,000 people.
The study is currently expected to finish around December 2029.
The main measurement is taken over: The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpointEndpointThe specific thing a study measures to answer its question.Read more → events have occurred (an estimated average follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → of 4 years).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Ischemic stroke or systemic embolism — measured over The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpointEndpointThe specific thing a study measures to answer its question.Read more → events have occurred (an estimated average follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → of 4 years).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05963698 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About WATCHMAN deviceDevice
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpointEndpointThe specific thing a study measures to answer its question.Read more → events have occurred (an estimated average follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → of 4 years)..
The study as a whole is currently expected to finish around 2029-12-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 4,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 23 locations, including: Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Burlington, Ontario, Canada; Cambridge, Ontario, Canada; Hamilton, Ontario, Canada, and 17 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (8)
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
The Feinstein Institutes for Medical Research
Manhasset, New York, United States
Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College and The New York Presbyterian Hospital
New York, New York, United States
NYU Grossman School of Medicine
New York, New York, United States
CommonSpirit Health Research Institute
Tacoma, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.