An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendag… (NCT05565599) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
United States58 participantsStarted 2022-10-21
Plain-language summary
This is an early feasibility 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:
* Documented non-valvular atrial fibrillation (AF), defined as AF (paroxysmal, persistent, or permanent) in the absence of moderate-to-severe mitral stenosis or a mechanical heart valve
* Participant greater than or equal to (\>=)18 years old
* CHA2DS2-VASc score \>=2 in men and \>= 3 in women
* Participant is recommended for chronic oral anticoagulation therapy (OAC) but is not eligible or has an appropriate rationale to seek a non-pharmacologic alternative to chronic OAC
* Participant deemed appropriate for LAA closure by the Site Heart Team using an evidenced based decision-making tool
* Participant eligible for the protocol-specified post-procedural antithrombotic regimen
* Participant or Legally Authorized Representative informed of the nature of the study, is willing and able to comply with the protocol, and has provided written informed consent per Institutional Review Board (IRB) requirements
Exclusion Criteria:
* Single episode, transient, or reversible AF (for example, secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
* Stroke or transient ischemic attack within 90 days before the index procedure
* Myocardial infarction or unstable angina within 90 days before the index procedure
* Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (\<)30 milliliters per minute (mL/min)/1.73 sqaure meter (m\^2), or dialysis at the time of screening
* Active infection with bacte…