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AzTrials

Coronary Artery DiseaseCALAMBRENCT07260474

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

A study testing Patients implanted with Amplatzer Amulet™ and Patients implanted with LAmbre™ in people with Coronary Artery Disease, run by Fundación EPIC at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Patients implanted with Amplatzer Amulet™ and Patients implanted with LAmbre™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSpain
Study dates
5 May 2024to 31 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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..

Who cannot join

  • (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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

BORJA Rivero-Santana, MD, PhD contact

0034696170677

borja.riversa@gmail.com

FUNDACION EPIC contact

0034987876135

iepic@fundacionepic.org

Spain1 site, 1 recruiting

  • Hospital Universitario La Paz

    Fuencarral-El Pardo, 28046

    Recruiting

Other trials in Spain

About this study

Official title: Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure: the CALAMBRE Randomized Clinical Trial

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.

Read the 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.

Being tested
Patients implanted with Amplatzer Amulet™, Patients implanted with LAmbre™
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT07260474
Study groupRoleWhat they receive
Amplatzer Amulet™left atrial appendage occluderOtherNot described
Receives: Device: Patients implanted with Amplatzer Amulet™
LAmbre™left atrial appendage occluderOtherNot described
Receives: Device: Patients implanted with LAmbre™

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (7)

  1. SAFETY: Clinical success

    Percentage of Device success plus absence of all-cause mortality, stroke, systemic embolism, or procedure-related complications at 90 days.

    Measured: 3 months

  2. 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).

    Measured: 7 days

  3. EFFICACY: Residual leak

    Percentage of residual leak >5 mm as assessed by TEE or CCTA (core lab evaluation).

    Measured: 3 months

  4. EFFICACY: Residual leak

    Percentage of residual leak >5 mm as assessed by TEE or CCTA (core lab evaluation).

    Measured: 12 months

  5. 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.

    Measured: 3 months

  6. 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)).

    Measured: 3 months

  7. 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)).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start5 May 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07260474
Sponsor's protocol ID
EPIC48-CALAMBRE
Acronym
CALAMBRE
Status last verified
Oct 2026
First submitted
21 Nov 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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 Nov 9.

    PubMed 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.

    PubMed 38088437

Questions about this trial

What is this clinical trial studying?

A study testing Patients implanted with Amplatzer Amulet™ and Patients implanted with LAmbre™ in people with Coronary Artery Disease, run by Fundación EPIC at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BORJA Rivero-Santana, MD, PhD (0034696170677, borja.riversa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EFFICACY: Device success (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07260474, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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