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

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Non-valvular Atrial Fibrillation

Treatments: Device: WATCHMAN LAA occluder

Study type: Interventional

Funder types: Other

Identifiers

NCT03917563

KY20182078-X-1

Details and patient eligibility

About

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

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is 18 years of age or above;
2. Patient is eligible for a WATCHMAN device according to current international and local guide-lines and per physician discretion;
3. 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

1. 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.
2. 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.
3. Patient is unable or not willing to complete follow-up visits and examination as required as part of the WATCHMAN procedure.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,050 participants in 1 patient group

Intervention group

Experimental group

Description:

WATCHMAN LAA occluder treatment

Treatment:

Device: WATCHMAN LAA occluder