NCT06168942

A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination

Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).

Detailed description

This prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).

Conditions

• Non-valvular Atrial Fibrillation
• Stroke
• Systemic Embolism

Interventions

Type	Name	Description
DEVICE	Experimental: Laminar Left Atrial Appendage Closure System	Treatment with the Laminar Left Atrial Appendage Closure System.
DEVICE	Active Comparator: WATCHMAN / Amulet	Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder.

Timeline

• Start date: 2024-02-19
• Primary completion: 2028-12-01
• Completion: 2032-02-29
• First posted: 2023-12-13
• Last updated: 2026-04-13

Locations

71 sites across 11 countries: United States, Belgium, Czechia, Denmark, France, Germany, Italy, Lithuania, Netherlands, Poland, Spain

Regulatory

• FDA-regulated device study