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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

China54 participantsStarted 2023-11-16

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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;

What they're measuring

Incidence of device-related thrombosis

Timeframe: 24 weeks post-LAAC

Incidence of stroke and transient ischemic attack

Timeframe: 24 weeks post-LAAC

Trial details

NCT IDNCT05761704

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-16

Contact for this trial

Youqi Fan

+86-13867482684 fanyouqi1228@126.com

View on ClinicalTrials.gov More Non-valvular Atrial Fibrillation trials