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

Study Overview
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Brief Summary
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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

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

Conditions
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Non-valvular Atrial Fibrillation

Intervention / Treatment
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* Device: WATCHMAN LAA occluder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>WATCHMAN LAA occluder treatment | Device: WATCHMAN LAA occluder<br>* WATCHMAN LAA occluder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death |  | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Life threatening or disabling, major bleeding and Minor bleeding | Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure | 
| Vascular access-related complications | Haematoma at access site<6 cm; Retroperitoneal haematoma;Arteriovenous fistula;Vascular surgical repair at catheter access sites;Pulmonary embolism;Ipsilateral deep vein thrombosis;Access site-related infection requiring intravenous antibiotics or extended hospitalization | Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure | 
| Device-related complications | Device embolization; Device erosion;Clinically significant device interference with surrounding structure;Device thrombus;Device fracture;Device infection/endocarditis/pericarditis;Device perforation/laceration;Device allergy | Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation