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 patient is a male or non-pregnant female ≥18 years of age
The patient has documented paroxysmal, persistent, or permanent non- valvular atrial fibrillation
The patient has a CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥ 3, and is recommended for oral anticoagulation therapy
The patient is deemed by their physician to be suitable for short-term warfarin therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation
Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
Patients with atrial fibrillation that is defined by a single occurrence, or that is transient or reversible (e.g., secondary to CABG, an interventional procedure, pneumonia, or hyperthyroidism)
Patients who require long-term anticoagulation for a condition other than atrial fibrillation
Patients with an indication for chronic P2Y12 platelet inhibition therapy
Parallel
LAmbre investigational device
DeviceRandomized 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.
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.
Major procedure related complications - device embolization
Procedure complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Major adverse event - Death
Death is observed by lack of oxygen, lack of pulse, succession of neurological activity.
Major adverse event
composite of cardiovascular death, overs CNS injury and major bleeding
mortality
cardiovascular or non-cardiovascular and reported cumulatively and individually
myocardial infarction
Defined as ST or nonST ECG changes with positive cardiac bio markers.
periprocedural stroke
Motor and sensory deficits observed and imaging confirmed.
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This trial is not recruiting at the moment. You can still explore other options:
