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

• ClinicalTrials.gov Identifier: NCT03033134
• Recruitment Status: Completed
• First Posted: January 26, 2017
• Results First Posted: January 8, 2019
• Last Update Posted: July 14, 2020
• Sponsor: Boston Scientific Japan K.K.
• Information provided by (Responsible Party): Boston Scientific Japan K.K.

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

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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: 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
3. 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.

Secondary Outcome Measures :

1. 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

2. 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

3. 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)

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: 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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Boston Scientific Japan K.K.
• ClinicalTrials.gov Identifier: NCT03033134
• Other Study ID Numbers: S6001
• First Posted: January 26, 2017
• Results First Posted: January 8, 2019
• Last Update Posted: July 14, 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

• 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:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes