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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amplatzer Amulet™left atrial appendage occluder | Other |
| |
| LAmbre™left atrial appendage occluder | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients implanted with Amplatzer Amulet™ | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| SAFETY: Clinical success | Percentage of Device success plus absence of all-cause mortality, stroke, systemic embolism, or procedure-related complications at 90 days. | 3 months |
| SAFETY: Procedure-related complications |
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Inclusion Criteria:
(MUST MEET ALL INCLUSION CRITERIA)
Exclusion Criteria:
(MUST NOT MEET ANY EXCLUSION CRITERIA)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BORJA Rivero-Santana, MD, PhD | Contact | 0034696170677 | borja.riversa@gmail.com | |
| FUNDACION EPIC | Contact | 0034987876135 | iepic@fundacionepic.org |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39027946 | Background | Landmesser U, Skurk C, Tzikas A, Falk V, Reddy VY, Windecker S. Left atrial appendage closure for stroke prevention in atrial fibrillation: current status and perspectives. Eur Heart J. 2024 Aug 21;45(32):2914-2932. doi: 10.1093/eurheartj/ehae398. | |
| 39570242 | Background | Lakkireddy D, Ellis CR, Thaler D, Swarup V, Gambhir A, Hermiller J, Nielsen-Kudsk JE, Worthley S, Nair D, Schmidt B, Horton R, Gupta N, Anderson JA, Zhao H, Alkhouli M, Windecker S. 5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial. J Am Coll Cardiol. 2025 Mar 25;85(11):1141-1153. doi: 10.1016/j.jacc.2024.10.101. Epub 2024 Nov 18. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Patients implanted with LAmbre™ | Device | Left atrial appendage closure with the LAmbre™ device. The procedure will be performed according to standard practice using the manufacturer's instructions for use. |
|
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).
| 7 days |
| EFFICACY: Residual leak | Percentage of residual leak >5 mm as assessed by TEE or CCTA (core lab evaluation). | 3 months |
| EFFICACY: Residual leak | Percentage of residual leak >5 mm as assessed by TEE or CCTA (core lab evaluation). | 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. | 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)). | 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)). | 12 months |
| 38310499 | Background | Alkhouli M, Freeman JV, Ellis CR, Shah AP, Gada H, Coylewright M, Lo M, Makkar A, Agarwal H, Lakkireddy D. First Experience With Amulet in the United States: Early Insights From EMERGE LAA Postapproval Study. JACC Cardiovasc Interv. 2024 Jan 19:S1936-8798(23)01553-4. doi: 10.1016/j.jcin.2023.11.027. Online ahead of print. |
| 37943004 | Background | Bangash AB, Li Y, Huang W, Zhong J, Zheng H, Zhang D, Zeng A, Wang R, Zhao W, Wang M, Zhao Y, Yu L, Liu Q, Jiang R, Jiang C, Zhang J. Left atrial appendage occlusion using the LAmbre device in atrial fibrillation patients with a history of ischemic stroke: 1-Year outcomes from a multicenter study in China. Pacing Clin Electrophysiol. 2023 Dec;46(12):1478-1483. doi: 10.1111/pace.14866. Epub 2023 Nov 9. |
| 38088437 | Background | Samaras A, Papazoglou AS, Balomenakis C, Bekiaridou A, Moysidis DV, Patsiou V, Orfanidis A, Giannakoulas G, Kassimis G, Fragakis N, Saw J, Landmesser U, Alkhouli MA, Tzikas A. Residual leaks following percutaneous left atrial appendage occlusion and outcomes: a meta-analysis. Eur Heart J. 2024 Jan 14;45(3):214-229. doi: 10.1093/eurheartj/ehad828. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |