Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology

Xijing Hospital1 site in 1 country1,050 target enrollmentApril 20, 2019

ConditionsNon-valvular Atrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-valvular Atrial Fibrillation
Sponsor: Xijing Hospital
Enrollment: 1050
Locations: 1
Primary Endpoint: The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the registry is to evaluate Chinese real-World clinical outcomes in patients With AF using the WATCHMAN left Atrial appendage closure technology

Registry

clinicaltrials.gov

Start Date

April 20, 2019

End Date

April 20, 2024

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xijing Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is 18 years of age or above;
•Patient is eligible for a WATCHMAN device according to current international and local guide-lines and per physician discretion;
•Patient is willing and capable of providing informed consent to participate in all procedures associated with receiving a WATCHMAN device at an approved clinical investigational center.

Exclusion Criteria

•Patient is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments.
•Patient is a woman of childbearing potential who is, or plans on becoming, pregnant during the duration of follow-up assessments required as part of the WATCHMAN procedure.
•Patient is unable or not willing to complete follow-up visits and examination as required as part of the WATCHMAN procedure.

Outcomes

Primary Outcomes

The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death

Time Frame: 12 months post procedure

Secondary Outcomes

Bleeding(Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure)
Vascular access-related complications(Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure)
Device-related complications(Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure)