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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03014557
Other study ID # T2016-ZX021
Secondary ID
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


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
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