China REgistry of WATCHMAN (CREW)

  • STATUS
    Recruiting
  • End date
    Dec 21, 2023
  • participants needed
    413
  • sponsor
    Fu Wai Hospital, Beijing, China
Updated on 27 January 2022
stroke
warfarin
fibrillation
vascular disease
left atrial appendage closure
embolism

Summary

This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population.

Description

In this prospective, multi-center, single arm observational study, 413 patients with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN device based on real clinical practice will be enrolled. Enrolled subjects will be followed up for 5 years.Primary endpoints include stroke, systematic embolism, cardiovascular death, and procedure or device related complications, etc.

Details
Condition Atrial Fibrillation, Left Atrial Appendage Closure
Treatment left atrial appendage closure device implantation
Clinical Study IdentifierNCT03014557
SponsorFu Wai Hospital, Beijing, China
Last Modified on27 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Non-valvular atrial fibrillation patient with CHA2DS2-VASC2, and with any one
of the following items
not suitable for long-term anti-coagulation therapy
stroke or embolism events in spite of warfarin treatment with intended INR
HAS-BLED3

Exclusion Criteria

Patient with any one of the following items will be excluded from the study
clinical exclusion criteria (any of the items) a congestive heart failure NYHA IV, b atrial septum defect, ASD surgery or closure c cardioversion or catheter ablation is planned within 30 days d with mechanic valve e left atrial appendage resection f heart transplantation g symptomatic jugular artery disease h previous stroke or TIA within 30 days i long term warfarin therapy is needed or contraindicated to warfarin j contraindicated to aspirin or clopidogrel k enrolled in other cardiac device or medicine trials l pregnant women or plan to pregnant during the study period m estimated life < 5 years
Echocardiography exclusion criteria (any of the items) a LVEF<30% b thrombus
or spontaneous echo imaging detected within two days prior to procedure c
patent foramen ovale d cardiac tumor e left atrial appendage orifice diameter
>32mm or < 17mm f the depth of left atrial appendage is less than the width g
prominent mitral stenosis (area <1.5cm2)
subject is not able to or will not complete the follow ups as planned
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