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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
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.
Serious adverse events
Absence of device or procedure related serious adverse events at 6 months after device implantation
Time frame: 6 months
Stable device placement
Stable device placement in left atrial appendage as assessed by transesophageal echocardiogram (TEE) at 6 months after device implant
Time frame: 6 months
Residual jet flow
Successful sealing around the device at the LAA orifice (residual jet flow of \< 5 mm) as measured by transesophageal echocardiogram (TEE) at 6 months after device implant
Time frame: 6 months
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