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

NCT05761704 | Unknown

• 1 other identifier: SAHZJU CT021
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-valvular Atrial Fibrillation

Keywords

Atrial Fibrillation; Left Atrial Appendage Closure; Ischemic Stroke; Device-related Thrombosis

Outcome Measures

Primary Outcomes (2)

• Incidence of device-related thrombosis

  Incidence of device-related thrombosis (DRT) at the visit of 4 weeks post-LAAC documented by CTA and the visit of 24 weeks post-LAAC documented by transesophageal echocardiogram (TEE).

  24 weeks post-LAAC

• Incidence of stroke and transient ischemic attack

  Incidence of stroke (classified as ischemic, hemorrhagic, or unspecified) and transient ischemic attack (TIA) before discharge or at 7 days, 4 weeks, and 24 weeks post-LAAC.

  24 weeks post-LAAC

Secondary Outcomes (8)

• Incidence of bleeding events

  24 weeks post-LAAC

• Incidence of systemic embolic events

  24 weeks post-LAAC

• Incidence of procedure-related complications

  24 weeks post-LAAC

• Incidence of composite clinical endpoint events

  24 weeks post-LAAC

• Incidence of all-cause mortality

  24 weeks post-LAAC

Study Arms (2)

Dual antiplatelet

EXPERIMENTAL

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).

Drug: Dual antiplatelet

Novel oral anticoagulant

EXPERIMENTAL

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).

Drug: Novel oral anticoagulant

Interventions

Dual antiplatelet 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).

Dual antiplatelet

Novel oral anticoagulant 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).

Novel oral anticoagulant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients ≥ 18 years old with non-valvular atrial fibrillation (AF);
• \. 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:
• Have a much higher risk of having stroke (CHA2DS2-VASc score: male ≥ 2 points, female ≥ 3 points),
• Have OAC intolerance or a much higher risk of bleeding (such as HAS-BLED score ≥ 3 points),
• Have sufficient life expectancy (minimum\>1 year) and expected to improve quality of life after LAAC;
• \. Successful left atrial appendage occlusion with LAMax LAAC® device;
• \. Patients and their families fully understand the purpose of the study, voluntarily participate in the study and sign the informed consent form.

You may not qualify if:

• \. Combined with other diseases except AF requiring long-term warfarin or other anticoagulant therapy;
• \. Absolute contraindications for anticoagulation therapy or unacceptable bleeding risk with dual antiplatelet therapy;
• \. 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);
• \. Occluder dislocation, pericardial effusion (including new pericardial effusion and significantly increased pre-existing pericardial effusion) and other bleeding complications within 24 hours after LAAC;
• \. Patients scheduled for catheter ablation after left atrial appendage electrical isolation and during the study;
• \. Patients resistant to clopidogrel;
• \. Patients requiring elective cardiac surgery;
• \. Heart failure NYHA grade IV and not been corrected yet;
• \. 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;
• \. Initial atrial fibrillation, paroxysmal atrial fibrillation with a clear cause such as coronary artery bypass grafting (CABG) \< 12 months, hyperthyroidism, etc.
• \. Patients with acute myocardial infarction or unstable angina pectoris, or recent myocardial infarction \< 12 months;
• \. Patients with active bleeding, bleeding constitution or bleeding disorders, coagulation history and unhealed gastrointestinal ulcer;
• \. Infective endocarditis, vegetation or other infections causing bacteremia, sepsis;
• \. Female patients who are pregnant, lactating, or planning to become pregnant during this study;
• \. Patients who have participated in other drug or device clinical trials and have not reached the endpoint;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke

Interventions

N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Youqi Fan

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youqi Fan

CONTACT

+86-13867482684; fanyouqi1228@126.com

Jian'an Wang

CONTACT

+86-13805786328; wangjianan111@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: November 16, 2023
• Primary Completion: November 16, 2024
• Study Completion: May 16, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

CN (1)