Clinical trial NCT03014557: China REgistry of WATCHMAN
Official title: China REgistry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Left Atrial Appendage Closure
Keywords: atrial fibrillation
left atrial appendage closure
WATCHMAN
Lead sponsor: Fu Wai Hospital, Beijing, China
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2017-01-09
Enrollment: 413
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non-valvular atrial fibrillation

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

Non-valvular atrial fibrillation patient with CHA2DS2-VASC≥2, and with any one of the following items:

1. not suitable for long-term anti-coagulation therapy;
2. stroke or embolism events in spite of warfarin treatment with intended INR
3. HAS-BLED≥3

Exclusion Criteria:

Patient with any one of the following items will be excluded from the study:

1. 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

2 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)

3 subject is not able to or will not complete the follow ups as planned

Primary outcomes:
measure: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events
timeFrame: between the time of enrollment and within 7 days of the procedure or by hospital discharge, whichever is later
measure: composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death.
timeFrame: 2 years
Secondary outcomes:
measure: Implantation success rate.
timeFrame: procedure
measure: Ischemic stroke or systemic embolism
timeFrame: excluding the first 7 days post enrollment.
measure: All Major Complications.
timeFrame: up to 5 years
measure: All-cause death.
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
Study officials:
References: