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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57586

Enrollment

175

Registered

2025-01-23

Start date

2026-01-29

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation, increased risk of stroke atrial fibrillation, increased risk of stroke

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. (a) Persistent or permanent AF, OR, (b) Paroxysmal AF in participants with a history of ischemic stroke or systemic embolism 2. Increased risk of stroke, defined as a CHA2DS2-VASc score of >= 4 3. 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

Exclusion criteria: 1. Age

Design outcomes

Primary

Measure	Time frame
Ischemic stroke or systemic embolism	—

Secondary

Measure	Time frame
1. All-cause stroke or systemic embolism 2. All-cause stroke, systemic embolism, or transient ischemic attack (TIA) 3. Decrease of two or more points in MoCA score, obtained at year two or End of Study (EOS) visit 4. New disabling ischemic stroke with modified Rankin Score (mRS) > 2, measured at 90 days post-stroke 5. Cardiovascular mortality 6. All-cause mortality	—

Countries

Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

Public ContactT McCready

Hamilton Health Sciences, Population Health Research Institute (PHRI)

tara.mccready@phri.ca905 296-5748

Outcome results