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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
54
BSJ003W implant
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Shonan Kamakura General Hospital
Number of Participants With Complications; One of the Following Events
All-cause death, ischemic stroke, systemic embolism, or device- or procedure- related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, arteriolar-venular fistula repair, or other major endovascular repair.
Time frame: Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later
Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)
The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant
Time frame: 24-month
The Rate of Effective Left Atrial Appendage (LAA) Closure
The effective LAA closure is defined as peri-device flow \<= 5mm demonstrated by TEE. TEE measurements will be assessed by an independent Core Laboratory.
Time frame: 45-day, 6-month, 12-month
Number of Participants With Major Bleeding
Major bleeding is defined as per BARC bleeding definition type 3 or 5. Type 3 Type 3a: Overt bleeding plus hemoglobin drop of 3 to 5 g/dL\* (provided hemoglobin drop is related to bleed), Any transfusion with overt bleeding Type 3b: Overt bleeding plus hemoglobin drop 5 g/dL\* (provided hemoglobin drop is related to bleed) Cardiac tamponade, Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), Bleeding requiring intravenous vasoactive agents Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 5: fatal bleeding Type 5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation
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Kamakura, Kanagawa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
Tokyo Medical and Dental University Medical Hospital
Bunkyo-ku, Tokyo, Japan
Sakakibara Heart Institute
Fuchū, Tokyo, Japan
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Time frame: 24-month
Number of Participants With Clinically Overt Non-fatal Bleeding
Clinically overt non-fatal bleeding is defined as per BARC bleeding definition type 2. Type 2: any overt, actionable sign of hemorrhage (eg, more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention by a healthcare professional, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation
Time frame: 24-month
Number of Participants With Ischemic Stroke or Systemic Embolism
The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later)
Time frame: 24-month