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

NCT ID: NCT05761704

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-16
• Study Completion Date: 2025-05-16

Brief Summary

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).

Detailed 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).

Conditions

Non-valvular Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dual antiplatelet

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).

Group Type: EXPERIMENTAL

Dual antiplatelet

Intervention Type: DRUG

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).

Novel oral anticoagulant

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).

Group Type: EXPERIMENTAL

Novel oral anticoagulant

Intervention Type: DRUG

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).

Interventions

Dual antiplatelet

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).

Intervention Type: DRUG

Novel oral anticoagulant

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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Jian'an Wang,MD,PhD

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Youqi Fan

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Youqi Fan

Role: CONTACT

fanyouqi1228@126.com

+86-13867482684

Jian'an Wang

Role: CONTACT

wangjianan111@zju.edu.cn

+86-13805786328

Facility Contacts

Youqi Fan, MD

Role: primary

fanyouqi1228@126.com

+86-13867482684

Other Identifiers

SAHZJU CT021

Identifier Type: -

Identifier Source: org_study_id