Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients implanted with Amplatzer Amulet™, Patients implanted with LAmbre™.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure: the CALAMBRE Randomized Clinical Trial
Overview
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.
Detailed description
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.
Interventions
- Device Patients implanted with Amplatzer Amulet™
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. - Device Patients implanted with LAmbre™
Left atrial appendage closure with the LAmbre™ device. The procedure will be performed according to standard practice using the manufacturer's instructions for use.
Primary outcome measures
- EFFICACY: Device success [Time frame: 3 months]
Secondary outcome measures (7)
- SAFETY: Clinical success [Time frame: 3 months]
- SAFETY: Procedure-related complications [Time frame: 7 days]
- EFFICACY: Residual leak [Time frame: 3 months]
- EFFICACY: Residual leak [Time frame: 12 months]
- SAFETY:Device-related thrombus (DRT) [Time frame: 3 months]
- SAFETY: MACE [Time frame: 3 months]
- SAFETY: MACE [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
(MUST MEET ALL INCLUSION CRITERIA)
- Patient with aged ≥18 years AND;
- Patient have non-valvular atrial (NVAF) with a CHA2DS2-VASc score ≥2, and presented at least one high-bleeding-risk criterion according to the Munich consensus document AND;
- Patient are required to undergo preprocedural TEE / CCTA to confirm the absence of LAA thrombus and to ensure that LAA anatomy is suitable for closure with either device.
- Patient who has been informed of the characteristics of the study and has provided written informed consent..
Exclusion criteria
(MUST NOT MEET ANY EXCLUSION CRITERIA)
- Patient life expectancy <1 year (terminal illness).
- Patient with requirement for oral anticoagulation therapy for any indication other than non-valvular atrial fibrillation.
- Patient with prior surgical ligation or obliteration of the left atrial appendage.
- Patient with history of allergic reaction or intolerance to any material used in the study devices or to any of the antithrombotic agents required post-procedure.
- Patient with active systemic infection.
- Patient with concurrent participation in another investigational study that may affect study results.
- Patient with inability or unwillingness to comply with the study protocol or follow-up requirements.
- Patient pregnant or breastfeeding women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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. PMID 39027946
- 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. PMID 39570242
- 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. PMID 38310499
- 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 No PMID 37943004
- 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. PMID 38088437
Identifiers
NCT: NCT07260474 · EPIC48-CALAMBRE