China REgistry of WATCHMAN

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

413 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2023-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Atrial Fibrillation Left Atrial Appendage Closure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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WATCHMAN

subjects with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN left atrial appendage closure device

left atrial appendage closure device implantation

Intervention Type DEVICE

to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach

Interventions

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left atrial appendage closure device implantation

to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach

Intervention Type DEVICE

Eligibility Criteria

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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