An interventional study of Left Atrial Appendage Closure in Non-valvular Atrial Fibrillation, sponsored by Biosense Webster, Inc.. Active, not recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Biosense Webster, Inc. · Not applicable, Interventional, and Treatment
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.
Left atrial appendage closure (LAAC) is an approved therapy for stroke prevention in atrial fibrillation patients who are recommended for chronic oral anticoagulation therapy (OAC), but are non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants in accordance with evidence-based decision-making criteria and current scientific guidelines.
The objective 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 who are deemed appropriate for LAAC to reduce the risk of stroke and systemic embolism.
Patients will be followed for 5 years after the procedure.
Biosense Webster, Inc. is the lead sponsor of 65 studies on the registry; 10 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure system.
Device: Left Atrial Appendage Closure
Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure System.
Composite Adverse Events
Composite rate of all-cause mortality, stroke, systemic embolism, life threatening or major bleeding (BARC Type 3 or 5), pericardial effusion requiring drainage, device embolization, and device- or procedure-related events requiring open cardiac surgery or major endovascular intervention.
Time frame: 45 days
Composite Adverse Events
Composite rate of all-cause mortality, stroke, systemic embolism, life threatening or major bleeding (BARC Type 3 or 5), pericardial effusion requiring drainage, device embolization, and device- or procedure-related events requiring open cardiac surgery or major endovascular intervention.
Time frame: 12 months
LAA Closure Rate
Rate of LAA closure defined by peri-device flow ≤ 3mm in width per TEE evaluated by independent core laboratory.
Time frame: 45 days
LAA Closure Rate
Rate of LAA closure defined by peri-device flow ≤ 3mm in width per TEE evaluated by independent core laboratory.
Time frame: 12 months
LAA Closure Rate
Rate of LAA closure per CCTA evaluated by independent core laboratory. Contrast patency defined as LAA density ≥100 HU or ≥25% of that of the left atrium.
Time frame: 45 days
Composite of Ischemic Stroke or System Embolism
Composite of ischemic stroke or systemic embolism.
Time frame: 12 months
Device-Related Thrombus
Rate of device-related thrombus (DRT) per CCTA evaluated by independent core laboratory.
Time frame: 45 days
Device-Related Thrombus
Rate of DRT per TEE evaluated by independent core laboratory.
Time frame: 12 months
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Biosense Webster, Inc.