The Fourth Left Atrial Appendage Occlusion Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamilton Health Sciences Corporation
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.
Eligibility criteria
Qualifiers
(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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- WATCHMAN device
Treatment groups
4,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hamilton Health Sciences Corporation
Lead sponsor
McMaster University
Collaborator
Population Health Research Institute
Collaborator
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov