China REgistry of WATCHMAN (CREW)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Left Atrial Appendage Closure
• Intervention / Treatment: Device: left atrial appendage closure device implantation

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 Type: Observational
• Enrollment (Anticipated): 413

Contacts and Locations

• Study Contact: Name: Zhengqin Zhai, MD PhD; Email: 384358085@qq.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Fuwai Hospital
    • Contact: Zhengqin Zhai, MD PhD; Email: 384358085@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

non-valvular atrial fibrillation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
WATCHMAN; 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; to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach

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

Collaborators and Investigators

• Sponsor: Fu Wai Hospital, Beijing, China
• Collaborators: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 9, 2017

Study Record Updates

• Last Update Posted (Estimate): January 9, 2017
• Last Update Submitted That Met QC Criteria: January 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: atrial fibrillation; left atrial appendage closure; WATCHMAN
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: T2016-ZX021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO