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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WATCHMAN | subjects with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN left atrial appendage closure device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| left atrial appendage closure device implantation | Device | to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach |
|
| 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 |
| 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 |
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Inclusion Criteria:
Non-valvular atrial fibrillation patient with CHA2DS2-VASC≥2, and with any one of the following items:
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
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non-valvular atrial fibrillation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengqin Zhai, MD PhD | Contact | 384358085@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |