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

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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..

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Amplatzer Amulet™left atrial appendage occluderOther 1 intervention
Group B: LAmbre™left atrial appendage occluderOther 1 intervention

Trial outcomes

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.

Time frame
3 months

Secondary outcomes

1

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
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).

Time frame
7 days
3

EFFICACY: Residual leak

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

Time frame
3 months
4

EFFICACY: Residual leak

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

Time frame
12 months

Other outcomes

Sponsors and contacts

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Fundación EPIC

Lead sponsor

Source ClinicalTrials.gov
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