NCT03122028

Clinical Investigation of the LAmbre Left Atrial Appendage Closure System

A Prospective, Non-Randomized, Multi-Center, Open-Label, Non-Comparative, Interventional Clinical Investigation of the LAmbre Left Atrial Appendage Closure System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or permanent atrial fibrillation, by using imaging approaches, i.e. combined trans-esophageal and transthoracic echocardiography. The conducted LA-EU-01 study was a prospective, non-randomized, multi-center, open-label, non-comparative, interventional clinical investigation with the participation of two clinical centers in Germany and the inclusion of 61 subjects. Participating subjects were patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability and scheduled for interventional closure of the left atrial appendage who could not be treated with anticoagulation. After the procedure of implantation of the LAmbreTM Left Atrial Appendage Closure System, patients underwent a first follow up assessment prior to hospital discharge then at 30 days, 6 and 12 months.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	LAA closure system	Patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability and cannot be treated with anticoagulation and scheduled for interventional left atrial appendage closure.

Timeline

• Start date: 2013-11-05
• Primary completion: 2016-03-09
• Completion: 2016-11-09
• First posted: 2017-04-20
• Last updated: 2017-04-21