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

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)

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation Non-Rheumatic
• Intervention / Treatment: Device: BSJ003W

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 802-8255
      • Kokura Memorial Hospital
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 305-8576
      • University of Tsukuba Hospital
  • Iwate
    • Morioka, Iwate, Japan, 020-8505
      • Iwate Medical University Hospital
  • Kanagawa
    • Kamakura-city, Kanagawa, Japan, 247-8533
      • Shonan Kamakura General Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-0873
      • Sendai Kousei Hospital
  • Osaka
    • Suita, Osaka, Japan, 565-8565
      • National Cerebral and Cardiovascular Center
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Tokyo Medical And Dental University Medical Hospital
    • Fuchu, Tokyo, Japan, 183-0003
      • Sakakibara Heart Institute
    • Meguro-ku, Tokyo, Japan, 153-8515
      • Toho University Ohashi Medical Center
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BSJ003W; BSJ003W implant group	Device: BSJ003W; BSJ003W implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	45-day, 6-month, 12-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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)	24-month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success Rate	Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.	Implant Day
Warfarin Discontinuation Rate	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.	45-day, 6-month, 12-month

Collaborators and Investigators

• Sponsor: Boston Scientific Japan K.K.
• Investigators: Principal Investigator: Kazutaka Aonuma, Tsukuba University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2017
• Primary Completion (ACTUAL): February 1, 2018
• Study Completion (ACTUAL): September 5, 2019

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (ESTIMATE): January 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: S6001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD 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

Drug and device information, study documents

• 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