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
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: No
View:

• The subject is Japanese, over 20 years old and provides written informed consent to participate in the trial

• The subject has documented paroxysmal, persistent or permanent non-valvular atrial fibrillation

• The subject has a calculated CHA2DS2-VASc score of 2 or greater and is recommended for long-term oral anti-coagulation therapy

• 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

• 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).

Locations
Other Locations
Japan
Tokyo Medical and Dental University Medical Hospital
Bunkyo-ku
Sakakibara Heart Institute
Fuchu
Shonan Kamakura General Hospital
Kamakura-city
Kokura Memorial Hospital
Kitakyushu
Toho University Ohashi Medical Center
Meguro-ku
Iwate Medical University Hospital
Morioka
Sendai Kousei Hospital
Sendai
Keio University Hospital
Shinjuku-ku
National Cerebral and Cardiovascular Center
Suita
University of Tsukuba Hospital
Tsukuba
Time Frame
Start Date: February 27, 2017
Completion Date: September 5, 2019
Participants
Target number of participants: 54
Treatments
Experimental: BSJ003W
BSJ003W implant group
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Japan K.K.

This content was sourced from clinicaltrials.gov

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