Atrial Fibrillation Non-RheumaticSALUTENCT03033134

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

A study testing BSJ003W in people with Atrial Fibrillation Non-Rheumatic, run by Boston Scientific Japan K.K. at 10 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Atrial Fibrillation Non-Rheumatic
What is being tested?: BSJ003W
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 10 sitesJapan
Study dates: 27 Feb 2017to 5 Sep 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

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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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Japan10 sites

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

Other trials in Japan

About this study

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)

Conditions: Atrial Fibrillation Non-Rheumatic
Being tested: BSJ003W

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BSJ003WDevice
BSJ003W implant

Study groups in NCT03033134
Study group	Role	What they receive
BSJ003W	Experimental	BSJ003W implant group Receives: Device: BSJ003W

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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.
Measured: 45-day, 6-month, 12-month

Secondary outcomes (3)

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
Measured: 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
Measured: 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)
Measured: 24-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Feb 20175 Sep 2019

First posted26 Jan 2017 (estimated)
Study start27 Feb 2017
Primary completion1 Feb 2018
Study completion5 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atrial Fibrillation Non-RheumaticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03033134
Sponsor's protocol ID: S6001
Acronym: SALUTE
Status last verified: Jan 2020
First submitted: 16 Jan 2017
Last updated: 14 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: 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

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.
PubMed 32595176

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03033134
Acronym / sponsor ID: SALUTE / S6001
Conditions: Atrial Fibrillation Non-Rheumatic
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Boston Scientific Japan K.K.Industry (pharma, biotech, devices)
Study start: 27 Feb 2017 (actual)
Primary completion: 1 Feb 2018 (actual)
Study completion: 5 Sep 2019 (actual)
First posted: 26 Jan 2017 (estimated)
Results: Posted 8 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BSJ003W	Experimental	Device: BSJ003WBSJ003W implant group

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BSJ003WBSJ003W implant	Device	BSJ003W

Primary outcome

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: 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
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.

3 secondary outcomes

Number of Participants With Major Bleeding
Time frame: 24-month
Number of Participants With Clinically Overt Non-fatal Bleeding
Time frame: 24-month
Number of Participants With Ischemic Stroke or Systemic Embolism
Time frame: 24-month

Results and safety

Results posted to the registry on 8 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implant (ITT)	42	0
Roll-in	12	0

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Implant (ITT) n = 42	Roll-in n = 12
Value	0	0

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Implant (ITT) n = 42	Roll-in n = 12
Ischemic stroke	3	1
Hemorrhagic stroke	0	0
Systemic embolism	0	0
Cardiovascular death	1	0

Population analysed: Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.

Primary outcome: The Rate of Effective Left Atrial Appendage (LAA) Closure

Time frame: 45-day, 6-month, 12-month. Count of participants. Unit: Participants

Measure	Implant (ITT) n = 42	Roll-in n = 12
At 45-day	42	12
At 6-month	42	11
At 12-month	41	11

Population analysed: Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort. One subject in Roll-in cohort at 6-month was not able to assessed by the Core laboratory due to the quality of the images

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implant (ITT)	13 of 42 (31%)	31 of 42 (73.8%)	1 of 42
Roll-in	6 of 12 (50%)	11 of 12 (91.7%)	1 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32595176Aonuma 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.
Individual participant dataSharing planned: No. 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

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kazutaka Aonuma principal investigator

Tsukuba University Hospital

Shigeru Saito principal investigator

Shonankamakura General Hospital

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BSJ003W in people with Atrial Fibrillation Non-Rheumatic, run by Boston Scientific Japan K.K. at 10 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03033134, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.