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

LAAOS-4

The Fourth Left Atrial Appendage Occlusion Study

Lead PI & Sponsor

Dr. Jeff Healey, PHRI

Local PI

Dr. Allan Skanes

Research Staff

Trinity Papamandjaris

Objective

The purpose of the LAAOS-4 study is to determine if closure of the left atrial appendage using a closure device called the WATCHMAN FLX™ or FLX PROTM, in addition to taking oral anticoagulant medications, is more effective at reducing strokes and blood clots in your body, than taking oral anticoagulant medications on their own.

Target Number of Patients

20

Currently Enrolled

0

Primary Outcomes

  • Ischemic stroke or systemic embolism

Secondary Outcomes

  • All-cause stroke or systemic embolism
  • All-cause stroke, systemic embolism or transient ischemic attack (TIA)
  • Decrease of two or more points in MoCA score, obtained at year two or End Of Study (EOS) visit
  • New disabling ischemic stroke with modified Rankin Score (mRS) >2, measured at 90 days post-stroke
  • Cardiovascular mortality
  • All-cause mortality

Inclusion Criteria

  • a) Persistent or permanent AF OR (b) Paroxysmal AF in participants with a history of ischemic stroke or systemic embolism
  • Increased risk of stroke, defined as a CHA2DS2-VASc score of ≥ 4
  • Treatment with OAC for at least 90 days prior to enrollment, AND no documented plan to permanently discontinue treatment with OAC for the expected duration of the trial

Exclusion Criteria

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

Atrial fibrillation is a common heart condition that happens when the top two chambers of the heart, called the atria, beat too fast and with an irregular rhythm (fibrillation). This condition can decrease the heart’s pumping capacity, which can cause blood cells to pool and stick together, forming clots in a small pouch on the heart called the left atrial appendage. If a clot escapes from the appendage and gets into your arteries, it may block the blood supply to your brain and cause a stroke. Atrial fibrillation is associated with a 3-5 times increased risk of stroke.

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