Exploring medication regimens after LAA closure for atrial fibrillation patients

A Prospective Exploratory Clinical Observation of Two Short-term Regimens (Dual Antiplatelet or Novel Oral Anticoagulant) for Subjects With Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion by LAMax LAAC® Device

This study is testing two different medication plans for people with atrial fibrillation after they have a procedure to close a part of the heart, to see which one helps prevent blood clots and strokes better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05761704 on ClinicalTrials.gov

What this trial studies

This clinical observation aims to evaluate the benefits of two short-term medication regimens following left atrial appendage (LAA) occlusion using the LAMax LAAC® device in patients with non-valvular atrial fibrillation. The study is a prospective, single-center, randomized, open-label design involving 54 participants who will be assigned to either a dual antiplatelet regimen or a novel oral anticoagulant regimen. The goal is to assess the safety and efficacy of these regimens in preventing thrombosis and reducing the risk of stroke and bleeding events post-procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with non-valvular atrial fibrillation who are at high risk for thromboembolism and unsuitable for long-term oral anticoagulants.

Not a fit: Patients who are not at high risk for thromboembolism or those who can tolerate long-term oral anticoagulants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved safety and efficacy of LAA closure procedures, reducing the risk of stroke and device-related thrombosis in patients with atrial fibrillation.

How similar studies have performed: While this approach is exploratory, similar studies have shown promise in evaluating short-term medication regimens post-LAA closure, indicating potential for success.

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.

Where this trial is running

Hangzhou, Zhejiang

• 2nd Affiliated Hospital, School of Medicine at Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Youqi Fan — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Youqi Fan

Conditions: Non-valvular Atrial Fibrillation, Atrial Fibrillation, Left Atrial Appendage Closure, Ischemic Stroke, Device-related Thrombosis