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

Primary Purpose

Atrial Fibrillation Non-Rheumatic

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
BSJ003W
Sponsored by
Boston Scientific Japan K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation Non-Rheumatic

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kokura Memorial Hospital
  • University of Tsukuba Hospital
  • Iwate Medical University Hospital
  • Shonan Kamakura General Hospital
  • Sendai Kousei Hospital
  • National Cerebral and Cardiovascular Center
  • Tokyo Medical and Dental University Medical Hospital
  • Sakakibara Heart Institute
  • Toho University Ohashi Medical Center
  • Keio University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BSJ003W

Arm Description

BSJ003W implant group

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

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
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
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)

Full Information

First Posted
January 16, 2017
Last Updated
June 29, 2020
Sponsor
Boston Scientific Japan K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT03033134
Brief Title
A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W
Acronym
SALUTE
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
September 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Japan K.K.

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation Non-Rheumatic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BSJ003W
Arm Type
Experimental
Arm Description
BSJ003W implant group
Intervention Type
Device
Intervention Name(s)
BSJ003W
Intervention Description
BSJ003W implant
Primary Outcome Measure Information:
Title
Number of Participants With Complications; One of the Following Events
Description
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
Title
Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)
Description
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
Title
The Rate of Effective Left Atrial Appendage (LAA) Closure
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With Major Bleeding
Description
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
Time Frame
24-month
Title
Number of Participants With Clinically Overt Non-fatal Bleeding
Description
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
Title
Number of Participants With Ischemic Stroke or Systemic Embolism
Description
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
Other Pre-specified Outcome Measures:
Title
Technical Success Rate
Description
Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.
Time Frame
Implant Day
Title
Warfarin Discontinuation Rate
Description
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.
Time Frame
45-day, 6-month, 12-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: The subject has a prior stroke (ischemic or hemorrhagic) or transient ischemic attack within the 90 days prior to consent 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 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 The subject has a history of atrial septal repair or has an atrial septal defect/persistent foramen ovale device The subject has an implanted mechanical valve prosthesis in any position The subject currently New York Heart Association class IV congestive heart failure The subject is contraindicated to aspirin The subject is contraindicated or seriously allergic to thienopyridine The subject is of childbearing potential and is, or plans to become pregnant during the time of the study The subject is not able and willing to return for required follow-up visits and examinations Subjects who are currently enrolled in another investigational study (of which primary endpoint follow-up have not been completed yet). The subject has other reason not to be eligible for this study per investigators' discretion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazutaka Aonuma
Organizational Affiliation
Tsukuba University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shigeru Saito
Organizational Affiliation
Shonankamakura General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8255
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kamakura-city
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
Sendai Kousei Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
Tokyo Medical and Dental University Medical Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Sakakibara Heart Institute
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
183-0003
Country
Japan
Facility Name
Toho University Ohashi Medical Center
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
32595176
Citation
Aonuma K, Yamasaki H, Nakamura M, Matsumoto T, Takayama M, Ando K, Hirao K, Goya M, Morino Y, Hayashida K, Kusano K, Gomi Y, Main ML, Uchida T, Saito S. Efficacy and Safety of Left Atrial Appendage Closure With WATCHMAN in Japanese Nonvalvular Atrial Fibrillation Patients - Final 2-Year Follow-up Outcome Data From the SALUTE Trial. Circ J. 2020 Jul 22;84(8):1237-1243. doi: 10.1253/circj.CJ-20-0196. Epub 2020 Jun 26.
Results Reference
derived

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

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