China REgistry of WATCHMAN

• Conditions: Left Atrial Appendage Closure; Atrial Fibrillation
• Interventions: Device: left atrial appendage closure device implantation

• Registration Number: NCT03014557
• Lead Sponsor: Fu Wai Hospital, Beijing, China

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.

Study Timeline

• Study Start: 2016-11
• Status Verified: 2017-01
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-05
• Last Update Submitted: 2017-01-05
• Study First Posted: 2017-01-09
• Last Update Posted: 2017-01-09
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 413

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
WATCHMAN	left atrial appendage closure device implantation	subjects with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN left atrial appendage closure device

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, China