A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W (SALUTE)
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|ClinicalTrials.gov Identifier: NCT03033134|
Recruitment Status : Completed
First Posted : January 26, 2017
Results First Posted : January 8, 2019
Last Update Posted : July 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Non-Rheumatic||Device: BSJ003W||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||February 27, 2017|
|Actual Primary Completion Date :||February 1, 2018|
|Actual Study Completion Date :||September 5, 2019|
BSJ003W implant group
- Number of Participants With Complications; One of the Following Events [ Time Frame: Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later ]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.
- Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause) [ Time Frame: 24-month ]The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant
- The Rate of Effective Left Atrial Appendage (LAA) Closure [ Time Frame: 45-day, 6-month, 12-month ]
The effective LAA closure is defined as peri-device flow <= 5mm demonstrated by TEE.
TEE measurements will be assessed by an independent Core Laboratory.
- Number of Participants With Major Bleeding [ Time Frame: 24-month ]
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
- Number of Participants With Clinically Overt Non-fatal Bleeding [ Time Frame: 24-month ]
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
- Number of Participants With Ischemic Stroke or Systemic Embolism [ Time Frame: 24-month ]The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later)
- Technical Success Rate [ Time Frame: Implant Day ]Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.
- Warfarin Discontinuation Rate [ Time Frame: 45-day, 6-month, 12-month ]
Warfarin discontinuation rate per protocol. If the TEE shows adequate seal of the LAA with a jet around the device <= 5mm, warfarin therapy should be discontinued.
Some patients restarted warfarin therapy due to the reasons other than the status of LAA closure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033134
|Kokura Memorial Hospital|
|Kitakyushu, Fukuoka, Japan, 802-8255|
|University of Tsukuba Hospital|
|Tsukuba, Ibaraki, Japan, 305-8576|
|Iwate Medical University Hospital|
|Morioka, Iwate, Japan, 020-8505|
|Shonan Kamakura General Hospital|
|Kamakura-city, Kanagawa, Japan, 247-8533|
|Sendai Kousei Hospital|
|Sendai, Miyagi, Japan, 980-0873|
|National Cerebral and Cardiovascular Center|
|Suita, Osaka, Japan, 565-8565|
|Tokyo Medical and Dental University Medical Hospital|
|Bunkyo-ku, Tokyo, Japan, 113-8519|
|Sakakibara Heart Institute|
|Fuchu, Tokyo, Japan, 183-0003|
|Toho University Ohashi Medical Center|
|Meguro-ku, Tokyo, Japan, 153-8515|
|Keio University Hospital|
|Shinjuku-ku, Tokyo, Japan, 160-8582|
|Principal Investigator:||Kazutaka Aonuma||Tsukuba University Hospital|
|Principal Investigator:||Shigeru Saito||Shonankamakura General Hospital|