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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 : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Japan K.K.

Tracking Information
First Submitted Date  ICMJE January 16, 2017
First Posted Date  ICMJE January 26, 2017
Results First Submitted Date  ICMJE October 15, 2018
Results First Posted Date  ICMJE January 8, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE February 27, 2017
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • 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: 6-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 ]
    The effective LAA closure is defined as peri-device flow <= 5mm demonstrated by TEE. TEE measurements will be assessed by an independent Core Laboratory.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • The occurrence of one of the following events [ Time Frame: Between the time of implant and within 7 days following the procedure or by hospital discharge assessed up to 10 days, 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.
  • The occurrence of composite events* including stroke (all/ ischemic/ hemorrhagic), systemic embolism and Cardiovascular(CV) death (including unexplained cause) [ Time Frame: 6-month ]
  • The Rate of Effective Left Atrial Appendage (LAA) Closure [ Time Frame: 45-day, 6-month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • Number of Participants With Major Bleeding [ Time Frame: 0 - 6 months ]
    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: 0 - 6 months ]
    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: 6-month ]
    The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • The occurrence of major bleeding [ Time Frame: 0 - 45 days, 45 days - 6 months, 6 months - 24 months ]
  • Frequency of the bleeding events [ Time Frame: 0 - 45 days, 45 days - 6 months and 6 months - 24 months ]
    Clinically overt non-fatal bleeding, All bleeding events
  • The occurrence of composite events* including stroke (all/ ischemic/ hemorrhagic), systemic embolism and CV death (including unexplained cause) [ Time Frame: 12-month, 24-month ]
  • The rate of effective LAA closure [ Time Frame: 12-month ]
  • The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later) [ Time Frame: 6-month, 12-month and 24-month ]
Current Other Pre-specified Outcome Measures
 (submitted: December 18, 2018)
  • 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: till 6-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.
Original Other Pre-specified Outcome Measures
 (submitted: January 24, 2017)
  • Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary. [ Time Frame: Implant Day ]
  • Occurrence of reportable adverse events [ Time Frame: 24-month ]
  • Occurrence of all-cause mortality [ Time Frame: 24-month ]
  • Individual occurrence of all-cause death, ischemic stroke,hemorrhagic stroke, systemic embolization, cardiovascular death (including unexplained cause) [ Time Frame: 6-month, 12-month and 24-month ]
  • Warfarin Discontinuation Rate [ Time Frame: 45-day, 6-month and 12-month ]
  • Severity of stroke assessed by Barthel Index [ Time Frame: 24-month ]
  • Severity of stroke assessed by NIH Stroke Score [ Time Frame: 24-month ]
  • Severity of stroke assessed by Modified Rankin Scale Score [ Time Frame: 24-month ]
  • EQ-5D assessment [ Time Frame: 24-month ]
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W
Official Title  ICMJE 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)
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Atrial Fibrillation Non-Rheumatic
Intervention  ICMJE Device: BSJ003W
BSJ003W implant
Study Arms  ICMJE Experimental: BSJ003W
BSJ003W implant group
Intervention: Device: BSJ003W
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2017)
54
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
60
Actual Study Completion Date  ICMJE September 5, 2019
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033134
Other Study ID Numbers  ICMJE S6001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description:

The confidentiality of records/data obtained in the trial will remain anonymous for analysis and publication.

The information and data, obtained from the trial is used without personal identification

Responsible Party Boston Scientific Japan K.K.
Study Sponsor  ICMJE Boston Scientific Japan K.K.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kazutaka Aonuma Tsukuba University Hospital
Principal Investigator: Shigeru Saito Shonankamakura General Hospital
PRS Account Boston Scientific Japan K.K.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP