Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT05761704
Eligibility Criteria:
Inclusion Criteria:
* 1\. Patients ≥ 18 years old with non-valvular atrial fibrillation (AF);
* 2\. 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:
1. Have a much higher risk of having stroke (CHA2DS2-VASc score: male ≥ 2 points, female ≥ 3 points),
2. Have OAC intolerance or a much higher risk of bleeding (such as HAS-BLED score ≥ 3 points),
3. Have sufficient life expectancy (minimum\>1 year) and expected to improve quality of life after LAAC;
* 3\. Successful left atrial appendage occlusion with LAMax LAAC® device;
* 4\. 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;
* 2\. Absolute contraindications for anticoagulation therapy or unacceptable bleeding risk with dual antiplatelet therapy;
* 3\. 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);
* 4\. Occluder dislocation, pericardial effusion (including new pericardial effusion and significantly increased pre-existing pericardial effusion) and other bleeding complications within 24 hours after LAAC;
* 5\. Patients scheduled for catheter ablation after left atrial appendage electrical isolation and during the study;
* 6\. Patients resistant to clopidogrel;
* 7\. Patients requiring elective cardiac surgery;
* 8\. Heart failure NYHA grade IV and not been corrected yet;
* 9\. 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;
* 10\. Initial atrial fibrillation, paroxysmal atrial fibrillation with a clear cause such as coronary artery bypass grafting (CABG) \< 12 months, hyperthyroidism, etc.
* 11\. Patients with acute myocardial infarction or unstable angina pectoris, or recent myocardial infarction \< 12 months;
* 12\. Patients with active bleeding, bleeding constitution or bleeding disorders, coagulation history and unhealed gastrointestinal ulcer;
* 13\. Infective endocarditis, vegetation or other infections causing bacteremia, sepsis;
* 14\. Female patients who are pregnant, lactating, or planning to become pregnant during this study;
* 15\. Patients who have participated in other drug or device clinical trials and have not reached the endpoint;
* 16\. Patients with renal insufficiency (endogenous creatinine clearance \< 30ml/min) (using the standard Crockcroft-Gault formula) and/or advanced renal disease requiring dialysis;
* 17\. 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);
* 18\. Patients considered unsuitable for this study by the investigator.
* 19\. Left atrial appendage has been removed, post heart transplantation, post atrial septal repair, or post occluder implantation;
* 20\. Post prosthetic heart valve replacement;
* 21\. Allergic to or contraindication to metal nickel alloy, aspirin, clopidogrel, contrast agent, heparin and other anticoagulants, etc;
* 22\. Patients who have placed other instruments in the cardiovascular cavity and are unable to place the LAA occluder;
* 23\. LVEF（left ventricular ejection fraction, by Simpson method）\<35%；
* 24\. Clear thrombus is found in the heart before LAAC;
* 25\. TEE examination: the maximal orifice diameter of LAA is less than 12 mm, or more than 36 mm;
* 26\. Residual flow after LAAC \>5mm；
* 27\. Patent foramen ovale with high risk;
* 28\. Mitral stenosis with a valve area \<1.5cm2;
* 29\. Left atrial diameter (antero-posterior diameter) \> 65mm, or pericardial effusion more than a small amount, the depth of local effusion \> 10 mm;
* 30\. Contraindications to X-ray, or not suitable for TEE examination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05761704
Study Brief:
Protocol Section:
NCT05761704