China REgistry of WATCHMAN

Fu Wai Hospital, Beijing, China413 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

413

Conditions

Atrial Fibrillation Left Atrial Appendage Closure

Interventions

left atrial appendage closure device implantationDEVICE

to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Fuwai Hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 2 years

Secondary Outcomes

Implantation success rate.

Implantation success is defined as successful delivery and release of WATCHMAN into the LAA including successful recapture and retrieval if necessary.

Time frame: procedure

Ischemic stroke or systemic embolism

Time frame: 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.

Time frame: up to 5 years

All-cause death.

Time frame: up to 5 years

Central Contacts

Zhengqin Zhai, MD PhD

CONTACT

384358085@qq.com

Data from ClinicalTrials.gov

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