A Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure Syst… (NCT05224375) | Clinical Trial Compass
CompletedNot Applicable
A Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
Georgia29 participantsStarted 2021-12-09
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of the Laminar Left Atrial Appendage Closure System to treat patients with non-valvular atrial fibrillation that cannot take, or a have a reason to seek an alternative to anticoagulant medications.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject with documented Non-Valvular AF, defined as AF (paroxysmal, persistent, or permanent) in the absence of moderate-to-severe mitral stenosis or a mechanical heart valve.
✓. Subject must be ≥18 years of age.
✓. Subject has a calculated CHA2DS2-VASc score of 2 or greater, denoting a high risk for stroke or systemic embolism.
✓. Subject is recommended for chronic oral anticoagulation therapy (OAC), but is non eligible or has an appropriate rationale to seek a non-pharmacologic alternative to chronic OAC
✓. Subject deemed appropriate for LAA closure by the Site Heart Team
✓. Subject is eligible for the post-procedural antithrombotic regimen per protocol
✓. Subject (or legally authorized representative, (where allowed)) has been informed of the nature of the study, agrees to its provisions, is willing and able to comply with the protocol-required medications and follow-up visits, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
Exclusion criteria
✕. AF single episode or transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
✕. Recent (within 90 days pre-procedure) stroke or transient ischemic attack
✕. Subject with history of acute or recent myocardial infarction (MI) or unstable angina within 90 days
What they're measuring
1
Closure success using the Laminar Left Atrial Appendage Closure System