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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-27

Study Completion Date

2019-09-05

Brief Summary

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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

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Detailed Description

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Conditions

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Atrial Fibrillation Non-Rheumatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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BSJ003W

BSJ003W implant group

Group Type EXPERIMENTAL

BSJ003W

Intervention Type DEVICE

BSJ003W implant

Interventions

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BSJ003W

BSJ003W implant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The subject is Japanese, over 20 years old and provides written informed consent to participate in the trial
2. The subject has documented paroxysmal, persistent or permanent non-valvular atrial fibrillation
3. The subject has a calculated CHA2DS2-VASc score of 2 or greater and is recommended for long-term oral anti-coagulation therapy
4. The subject is deemed by their physicians to be suitable for anticoagulant therapy and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin
5. The subject is eligible to come off warfarin therapy if the LAA (left atrial appendage) is sealed (i.e. the subject has no other conditions that would require warfarin therapy).

Exclusion Criteria

1. The subject has a prior stroke (ischemic or hemorrhagic) or transient ischemic attack within the 90 days prior to consent
2. The subject has had a myocardial infarction either non-ST elevation or ST elevation myocardial infarction within 90 days prior to consent with or without intervention
3. The subject had or is planning to have any cardiac (e.g. cardioversion, coronary angiogram, percutaneous coronary intervention, cardiac ablation, etc.) or non-cardiac invasive or surgical procedure (e.g. cataract surgery, endoscopy, etc.) within 30 days prior or 45 days after the BSJ003W implant
4. The subject has a history of atrial septal repair or has an atrial septal defect/persistent foramen ovale device
5. The subject has an implanted mechanical valve prosthesis in any position
6. The subject currently New York Heart Association class IV congestive heart failure
7. The subject is contraindicated to aspirin
8. The subject is contraindicated or seriously allergic to thienopyridine
9. The subject is of childbearing potential and is, or plans to become pregnant during the time of the study
10. The subject is not able and willing to return for required follow-up visits and examinations
11. Subjects who are currently enrolled in another investigational study (of which primary endpoint follow-up have not been completed yet).
12. The subject has other reason not to be eligible for this study per investigators' discretion.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No