Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W (SALUTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Non-Rheumatic Device: BSJ003W Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BSJ003W
BSJ003W implant group
Device: BSJ003W
BSJ003W implant




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



Secondary Outcome Measures :
  1. 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


  2. 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


  3. 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)


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Japan
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
Sponsors and Collaborators
Boston Scientific Japan K.K.
Investigators
Layout table for investigator information
Principal Investigator: Kazutaka Aonuma Tsukuba University Hospital
Principal Investigator: Shigeru Saito Shonankamakura General Hospital
  Study Documents (Full-Text)

Documents provided by Boston Scientific Japan K.K.:
Study Protocol  [PDF] November 24, 2016
Statistical Analysis Plan  [PDF] November 10, 2017


Layout table for additonal information
Responsible Party: Boston Scientific Japan K.K.
ClinicalTrials.gov Identifier: NCT03033134    
Other Study ID Numbers: S6001
First Posted: January 26, 2017    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
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


Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes