Atrial Fibrillation Clinical Trial
— CREWOfficial title:
China REgistry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation
This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population.
Status | Recruiting |
Enrollment | 413 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Non-valvular atrial fibrillation patient with CHA2DS2-VASC=2, and with any one of the following items: 1. not suitable for long-term anti-coagulation therapy; 2. stroke or embolism events in spite of warfarin treatment with intended INR 3. 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Fuwai Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Fu Wai Hospital, Beijing, China | Boston Scientific Corporation |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Primary | composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death. | 2 years | Yes | |
Secondary | 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 | No |
Secondary | Ischemic stroke or systemic embolism | excluding the first 7 days post enrollment. | Yes | |
Secondary | 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 | Yes |
Secondary | All-cause death. | up to 5 years | Yes |
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