LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs

Peri-device leak size (in mm) three months after successful LAAO as assessed with TOE.

Defined as device deployed and implanted in correct position.

End time (closing of X-Ray) minus start time (access site puncture).

Defined as exclusion of the LAA with residual peri device leak size ≤ 5mm and no device-related complications during index hospitalization.

defined as technical success with no procedure-related complications, except for uncomplicated (minor) device embolization

All complications which are a result of the presence of the device and require either a surgical or percutaneous intervention or other medical treatment (device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection/pericarditis, endocarditis, device perforation/laceration or device allergy)

Pericardial effusion with or without tamponade requiring pericardiocentesis or surgical intervention.

Defined as Bleeding Academic Research Consortium (BARC) type ≥ 3.

Large peri device leak size (in mm) >5 mm three months after successful LAAO as assessed with TOE.

Device thrombus at three months after successful LAAO as assessed with TOE.

Cardiovascular Death:

• Death due to proximate cardiac cause, e.g. myocardial infarction, cardiac tamponade, worsening heart failure, and endocarditis.
• Death caused by non-coronary, non-CNS vascular conditions such as pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.
• Death from vascular CNS causes from haemorrhagic stroke or from ischaemic stroke.
• All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure.
• Sudden or unwitnessed death defined as non-traumatic, unexpected fatal event occurring within 1 hour of the onset of symptoms in an apparently healthy subject. If death is not witnessed, the definition applies when the victim was in good health 24 hours before the event.
• Death of unknown cause:

Non-cardiovascular death: Death of a primary cause that is clearly related to another condition (e.g. trauma, cancer, suicide).

Incidence of ischaemic stroke or systemic embolism, as described below.

Defined as an acute episode of focal or global neurological deficit with at least one of the following: change in the level of consciousness, hemiplegia, hemiparesis, one-sided numbness or sensory loss, dysphasia or aphasia, hemianopia, amaurosis fugax or any other neurological signs or symptoms consistent with stroke. It is caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. A transient ischemic attack (TIA) should be clearly distinguished from ischemic stroke, based on focal neurological symptoms lasting <24 hours and imaging-confirmed absence of acute brain infarction. Therefore, it is mandatory to recommend imaging confirmation as part of the diagnosis. Stroke assessment requires a neuroimaging and neurological examination, preferably by a neurologist.

Systemic embolism: Acute vascular insufficiency or occlusion of the extremities or any non-central nervous system organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g., trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.