Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure

NCT07260474 | Not Yet Recruiting DMC

• 1 other identifier: EPIC48-CALAMBRE
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• SAFETY: Clinical success

  3 months

• SAFETY: Procedure-related complications

  7 days

• EFFICACY: Residual leak

  3 months

• EFFICACY: Residual leak

  12 months

• SAFETY:Device-related thrombus (DRT)

  3 months

Study Arms (2)

Amplatzer Amulet™left atrial appendage occluder

OTHER

Device: Patients implanted with Amplatzer Amulet™

LAmbre™left atrial appendage occluder

OTHER

Device: Patients implanted with LAmbre™

Interventions

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.

LAmbre™left atrial appendage occluder

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.

Amplatzer Amulet™left atrial appendage occluder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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..

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación EPIC: lead

Related Publications (5)

• 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 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.

  PMID: 39570242 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.

  PMID: 38310499 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.

  PMID: 37943004 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.

  PMID: 38088437 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

BORJA Rivero-Santana, MD, PhD

CONTACT

0034696170677; borja.riversa@gmail.com

FUNDACION EPIC

CONTACT

0034987876135; iepic@fundacionepic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11