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A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W

NCT03033134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-07-14

Study results available
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Summary

The purpose of this study is to confirm the safety and effectiveness of the BSJ003W in Japanese patients with non-valvular atrial fibrillation at increased risk of thromboembolism in Japanese Clinical environment

Conditions

  • Atrial Fibrillation Non-Rheumatic

Interventions

DEVICE

BSJ003W

BSJ003W implant

Sponsors & Collaborators

  • Boston Scientific Japan K.K.

    lead INDUSTRY

Principal Investigators

  • Kazutaka Aonuma · Tsukuba University Hospital

  • Shigeru Saito · Shonankamakura General Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-27
Primary Completion
2018-02-01
Completion
2019-09-05
FDA Device
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03033134 on ClinicalTrials.gov