Clinical investigation with CE-marked medical devices, multicenter, prospective, randomized and controlled. Patients with non-valvular atrial fibrillation at high embolic risk and with at least one high bleeding risk criterion according to the Munich consensus document will be randomized to left atrial appendage closure with either the Amplatzer Amulet™ or the LAmbre™ device. The study is designed to compare the efficacy and safety of both devices regarding successful implantation, effective appendage closure, and clinical outcomes at follow-up.
Clinical investigation with CE-marked medical devices, multicenter, prospective, randomized and controlled. Patients with non-valvular atrial fibrillation at high embolic risk and with at least one high bleeding risk criterion according to the Munich consensus document will be randomized to left atrial appendage closure with either the Amplatzer Amulet™ or the LAmbre™ device. The study is designed to compare the efficacy and safety of both devices regarding successful implantation, effective appendage closure, and clinical outcomes at follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Left atrial appendage closure with the Amplatzer Amulet™ device. The procedure will be performed according to standard practice using the manufacturer's instructions for use.
Left atrial appendage closure with the LAmbre™ device. The procedure will be performed according to standard practice using the manufacturer's instructions for use.
EFFICACY: Device success
Percentage Device success defined as: Successful deployment and stable implantation of the assigned device within the left atrial appendage during the index procedure and no crossover to the alternative device and effective closure of the appendage with a residual leak ≤5 mm as assessed by TEE(Transesophageal Echocardiography) or CCTA (Cardiac Computed Tomography Angiography) at 90 days.
Time frame: 3 months
SAFETY: Clinical success
Percentage of Device success plus absence of all-cause mortality, stroke, systemic embolism, or procedure-related complications at 90 days.
Time frame: 3 months
SAFETY: Procedure-related complications
Percentage of Composite of death, stroke, systemic or pulmonary embolism, air embolism, any bleeding, pericardial effusion, vascular access complication, device-related complication, or AKI (Acute Kidney Injury) within 7 days (or later if related to the procedure).
Time frame: 7 days
EFFICACY: Residual leak
Percentage of residual leak \>5 mm as assessed by TEE or CCTA (core lab evaluation).
Time frame: 3 months
EFFICACY: Residual leak
Percentage of residual leak \>5 mm as assessed by TEE or CCTA (core lab evaluation).
Time frame: 12 months
SAFETY:Device-related thrombus (DRT)
Percentage of Homogeneous mass (TEE) or hypoattenuated thickening (CCTA) on the atrial surface of the device, adjudicated by independent imaging experts.
Time frame: 3 months
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SAFETY: MACE
Percentage of Composite of all-cause mortality, cardiovascular mortality, ischemic or hemorrhagic stroke, systemic embolism, pulmonary embolism, myocardial infarction, and bleeding (classified by BARC (Bleeding Academic Research Consortium)).
Time frame: 3 months
SAFETY: MACE
Percentage of Composite of all-cause mortality, cardiovascular mortality, ischemic or hemorrhagic stroke, systemic embolism, pulmonary embolism, myocardial infarction, and bleeding (classified by BARC (Bleeding Academic Research Consortium)).
Time frame: 12 months