--- title: A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W nct_id: NCT03033134 overall_status: COMPLETED phase: NA sponsor: Boston Scientific Japan K.K. study_type: INTERVENTIONAL primary_condition: Atrial Fibrillation Non-Rheumatic countries: Japan canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03033134.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03033134" ct_last_update_post_date: 2020-07-14 last_seen_at: "2026-05-12T07:22:52.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W **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) **NCT ID:** [NCT03033134](https://clinicaltrials.gov/study/NCT03033134) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 54 - **Lead Sponsor:** Boston Scientific Japan K.K. - **Conditions:** Atrial Fibrillation Non-Rheumatic - **Start Date:** 2017-02-27 - **Completion Date:** 2019-09-05 - **CT.gov Last Update:** 2020-07-14 ## 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 ## Eligibility - **Minimum age:** 20 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **BSJ003W** (EXPERIMENTAL) — BSJ003W implant group ## Interventions - **BSJ003W** (DEVICE) — BSJ003W implant ## Primary Outcomes - **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. ## 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)_ ## Locations (10) - Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan - University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan - Iwate Medical University Hospital, Morioka, Iwate, Japan - Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan - Sendai Kousei Hospital, Sendai, Miyagi, Japan - National Cerebral and Cardiovascular Center, Suita, Osaka, Japan - Tokyo Medical and Dental University Medical Hospital, Bunkyo-ku, Tokyo, Japan - Sakakibara Heart Institute, Fuchū, Tokyo, Japan - Toho University Ohashi Medical Center, Meguro-ku, Tokyo, Japan - Keio University Hospital, Shinjuku-ku, Tokyo, Japan ## Recent Field Changes (last 30 days) - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.kokura memorial hospital|kitakyushu|fukuoka|japan` — added _(2026-05-12)_ - `locations.university of tsukuba hospital|tsukuba|ibaraki|japan` — added _(2026-05-12)_ - `locations.iwate medical university hospital|morioka|iwate|japan` — added _(2026-05-12)_ - `locations.shonan kamakura general hospital|kamakura|kanagawa|japan` — added _(2026-05-12)_ - `locations.sendai kousei hospital|sendai|miyagi|japan` — added _(2026-05-12)_ - `locations.national cerebral and cardiovascular center|suita|osaka|japan` — added _(2026-05-12)_ - `locations.tokyo medical and dental university medical hospital|bunkyo-ku|tokyo|japan` — added _(2026-05-12)_ - `locations.sakakibara heart institute|fuchū|tokyo|japan` — added _(2026-05-12)_ - `locations.toho university ohashi medical center|meguro-ku|tokyo|japan` — added _(2026-05-12)_ - `locations.keio university hospital|shinjuku-ku|tokyo|japan` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03033134.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03033134* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*