NCT05565599

An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Non-valvular Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Left Atrial Appendage Closure	Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure System.

Timeline

• Start date: 2022-10-21
• Primary completion: 2024-08-07
• Completion: 2029-09-01
• First posted: 2022-10-04
• Last updated: 2025-09-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study