China REgistry of WATCHMAN

Study Overview
=================
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.

Official Title
-----------------
China REgistry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation, Left Atrial Appendage Closure

Intervention / Treatment
-----------------
* Device: left atrial appendage closure device implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-valvular atrial fibrillation patient with CHA2DS2-VASC≥2, and with any one of the following items: not suitable for long-term anti-coagulation therapy; stroke or embolism events in spite of warfarin treatment with intended INR 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| WATCHMAN<br>subjects with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN left atrial appendage closure device | Device: left atrial appendage closure device implantation<br>* to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause death, ischemic stroke, systemic embolism, or device or procedure related events | events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. | between the time of enrollment and within 7 days of the procedure or by hospital discharge, whichever is later | 
| composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation success rate. | Implantation success is defined as successful delivery and release of WATCHMAN into the LAA including successful recapture and retrieval if necessary. | procedure | 
| Ischemic stroke or systemic embolism |  | excluding the first 7 days post enrollment. | 
| All Major Complications. | Major complication is defined as death, stroke, MI or any other serious adverse events related to the device or procedure. | up to 5 years | 
| All-cause death. |  | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, left atrial appendage closure, WATCHMAN