NCT06465706

Assessing the Safety and Efficacy of the LAmbre™ Plus Device

A Prospective, Multicenter, Randomized Controlled Trial Assessing the Safety and Efficacy of the LAmbre™ Plus Left Atrial Appendage Closure System to REDUCE the Risk of Thromboembolism in Patients With Non-Valvular Atrial Fibrillation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,826 (estimated)
• Sponsor: Kansas City Heart Rhythm Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Randomized controlled trial assessing the safety and efficacy of the LAmbre Plus LAA Closure System to rescue the risk of thromboembolism in patients with non-valvular AF.

Detailed description

The goal of this clinical trial is to demonstrate the safety and efficacy of the LAmbre Plus device in patients with non-valvular atrial fibrillation in comparison with the commercially available transcatheter LAAO device(s). The main questions it aims to answer are: Overall safety of the device that is assessed at the 12 month time period. Overall efficacy, after all subjects have reached the 18 month time period. Participants will be randomized to either the LAmbre device or other FDA approved LAAO devices.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	LAmbre investigational device	Randomized 1:1 to either experimental group or control group.

Timeline

• Start date: 2024-09-01
• Primary completion: 2029-10-01
• Completion: 2030-01-31
• First posted: 2024-06-20
• Last updated: 2024-08-23

Regulatory

• FDA-regulated device study