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Exploratory Observation of Two Short-term Regimens After LAA Occlusion by LAMax LAAC® Device for Subjects With Non-valvular Atrial Fibrillation

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Zhejiang University

Status

Enrolling

Conditions

Non-valvular Atrial Fibrillation

Treatments

Drug: Novel oral anticoagulant
Drug: Dual antiplatelet

Study type

Interventional

Funder types

Other

Identifiers

NCT05761704
SAHZJU CT021

Details and patient eligibility

About

This is a prospective, single-center, randomized, exploratory clinical observation to explore the overall benefit of short-term dual antiplatelet or novel oral anticoagulant regimens after left atrial appendage (LAA) occlusion by LAMax LAAC® occluder for subjects with non-valvular atrial fibrillation (AF), which will provide a basis for subsequent research on real-world safety and efficacy of LAA closure (LAAC).

Full description

Anticoagulation is necessary after transcatheter left atrial appendage closure (LAAC) and is important to prevent thrombosis and device-related thrombosis (DRT). Bleeding events and stroke should be reduced while reducing thrombosis. Based on the characteristics of the LAMax LAAC® device, experts recommend studying short-term medication regimens for patients with non-valvular atrial fibrillation after LAAC. This trial is a prospective, single-center, randomized, open-label and parallel design. It is estimated that 54 patients will take part in the study. Subjects with non-valvular atrial fibrillation undergo transcatheter LAAC using the LAMax LAAC® device, and then are randomly enrolled in observation group 1/observation group 2 of the medication regimen in a 1:1 ratio after LAAC.

Observation group 1 (dual antiplatelet group, 27 subjects): 4 weeks post-LAAC (aspirin 100 mg + clopidogrel 75 mg); 4-24 weeks post-LAAC (aspirin/clopidogrel); recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).

Observation group 2 (novel oral anticoagulant group, 27 subjects): 4 weeks post-LAAC (conventional dose NOAC); 4-24 weeks post-LAAC (aspirin/clopidogrel); recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).

Enrollment

54 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

    1. Patients ≥ 18 years old with non-valvular atrial fibrillation (AF);
    1. Subjects with LAAC indications: according to the 2023 SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Attachment Closure, transcatheter LAAC is suitable for non-valvular AF patients with high risk of thromboembolism but unsuitable for long-term use of oral anticoagulants (OACs), including the following situations:

    2. Have a much higher risk of having stroke (CHA2DS2-VASc score: male ≥ 2 points, female ≥ 3 points),

    3. Have OAC intolerance or a much higher risk of bleeding (such as HAS-BLED score ≥ 3 points),

    4. Have sufficient life expectancy (minimum>1 year) and expected to improve quality of life after LAAC;

    1. Successful left atrial appendage occlusion with LAMax LAAC® device;
    1. Patients and their families fully understand the purpose of the study, voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

    1. Combined with other diseases except AF requiring long-term warfarin or other anticoagulant therapy;
    1. Absolute contraindications for anticoagulation therapy or unacceptable bleeding risk with dual antiplatelet therapy;
    1. Indications to dual antiplatelet therapy other than atrial fibrillation and/or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization);
    1. Occluder dislocation, pericardial effusion (including new pericardial effusion and significantly increased pre-existing pericardial effusion) and other bleeding complications within 24 hours after LAAC;
    1. Patients scheduled for catheter ablation after left atrial appendage electrical isolation and during the study;
    1. Patients resistant to clopidogrel;
    1. Patients requiring elective cardiac surgery;
    1. Heart failure NYHA grade IV and not been corrected yet;
    1. Patients with AF caused by rheumatic valvular heart disease, degenerative valvular heart disease, congenital valvular heart disease, severe mitral stenosis, aortic stenosis and other valvular diseases;
    1. Initial atrial fibrillation, paroxysmal atrial fibrillation with a clear cause such as coronary artery bypass grafting (CABG) < 12 months, hyperthyroidism, etc.
    1. Patients with acute myocardial infarction or unstable angina pectoris, or recent myocardial infarction < 12 months;
    1. Patients with active bleeding, bleeding constitution or bleeding disorders, coagulation history and unhealed gastrointestinal ulcer;
    1. Infective endocarditis, vegetation or other infections causing bacteremia, sepsis;
    1. Female patients who are pregnant, lactating, or planning to become pregnant during this study;
    1. Patients who have participated in other drug or device clinical trials and have not reached the endpoint;
    1. Patients with renal insufficiency (endogenous creatinine clearance < 30ml/min) (using the standard Crockcroft-Gault formula) and/or advanced renal disease requiring dialysis;
    1. Severe hepatic dysfunction (AST/ALT greater than 5 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal);
    1. Patients considered unsuitable for this study by the investigator.
    1. Left atrial appendage has been removed, post heart transplantation, post atrial septal repair, or post occluder implantation;
    1. Post prosthetic heart valve replacement;
    1. Allergic to or contraindication to metal nickel alloy, aspirin, clopidogrel, contrast agent, heparin and other anticoagulants, etc;
    1. Patients who have placed other instruments in the cardiovascular cavity and are unable to place the LAA occluder;
    1. LVEF(left ventricular ejection fraction, by Simpson method)<35%;
    1. Clear thrombus is found in the heart before LAAC;
    1. TEE examination: the maximal orifice diameter of LAA is less than 12 mm, or more than 36 mm;
    1. Residual flow after LAAC >5mm;
    1. Patent foramen ovale with high risk;
    1. Mitral stenosis with a valve area <1.5cm2;
    1. Left atrial diameter (antero-posterior diameter) > 65mm, or pericardial effusion more than a small amount, the depth of local effusion > 10 mm;
    1. Contraindications to X-ray, or not suitable for TEE examination.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

Dual antiplatelet
Experimental group
Description:
Aspirin 100 mg + clopidogrel 75 mg for 4 weeks post-LAAC; followed by aspirin/clopidogrel for 4-24 weeks post-LAAC; recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).
Treatment:
Drug: Dual antiplatelet
Novel oral anticoagulant
Experimental group
Description:
Conventional dose NOAC for 4 weeks post-LAAC; followed by aspirin/clopidogrel for 4-24 weeks post-LAAC; recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).
Treatment:
Drug: Novel oral anticoagulant

Trial contacts and locations

1

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Central trial contact

Youqi Fan; Jian'an Wang

Data sourced from clinicaltrials.gov

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