China REgistry of WATCHMAN

Atrial Fibrillation Clinical Trial

— CREW  

Official title:

China REgistry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03014557
• Other study ID #: T2016-ZX021
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2017
• Last updated: January 5, 2017
• Start date: November 2016
• Est. completion date: December 2023

Study information

• Verified date: January 2017
• Source: Fu Wai Hospital, Beijing, China
• Contact: Zhengqin Zhai, MD PhD
• Email: 384358085[@]qq.com
• Is FDA regulated: No
• Health authority: China: Hospital Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Atrial Appendage Closure

Intervention

Device:
• left atrial appendage closure device implantation
to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Fu Wai Hospital, Beijing, China	Boston Scientific Corporation

Country where clinical trial is conducted

China, 

Outcome

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