Trials / Completed
CompletedNCT03033134
A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W
A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W for Patients With Non-valvular Atrial Fibrillation at Increased Risk of ThromboEmbolism in Japanese Medical Environment (SALUTE)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Boston Scientific Japan K.K. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BSJ003W | BSJ003W implant |
Timeline
- Start date
- 2017-02-27
- Primary completion
- 2018-02-01
- Completion
- 2019-09-05
- First posted
- 2017-01-26
- Last updated
- 2020-07-14
- Results posted
- 2019-01-08
Locations
10 sites across 1 country: Japan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03033134. Inclusion in this directory is not an endorsement.