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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,826
Randomized 1:1 to either experimental group or control group.
Major procedure related complications - cardiac perforation
Cardiac perforation can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Time frame: up to 7 days following implant procedure
Major procedure related complications - pericardial effusion with tamponade or requiring drainage
Common complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Time frame: up to 7 days following implant procedure
Major procedure related complications - device embolization
Procedure complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Time frame: up to 7 days following implant procedure
Major adverse event - Death
Death is observed by lack of oxygen, lack of pulse, succession of neurological activity.
Time frame: up to 7 days following implant procedure
Major adverse event - all strokes
Stroke is identified by neurologic imaging and transient or permanent motor or sensory deficient.
Time frame: up to 7 days following implant procedure
Major adverse event - systemic embolization
Systemic embolization assessed by onsite symptoms and confirmed by diagnostic imaging.
Time frame: up to 7 days following implant procedure
Major adverse event - major bleeding
Visual bleeding or a drop in hemoglobin of 2 units and requiring transfusion.
Time frame: up to 7 days following implant procedure
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Major adverse event
composite of cardiovascular death, overs CNS injury and major bleeding
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
mortality
cardiovascular or non-cardiovascular and reported cumulatively and individually
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
myocardial infarction
Defined as ST or nonST ECG changes with positive cardiac bio markers.
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
periprocedural stroke
Motor and sensory deficits observed and imaging confirmed.
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
bleeding complications
Visual bleeding or a drop in hemoglobin
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
major procedure-related complications
vascular or cardiac complications occurring due to the procedure.
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
vascular complications
vascular complications are hematomas, aneurysms, and ischemic limb.
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years