Clinical trial NCT03033134: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation Non-Rheumatic
Lead sponsor: Boston Scientific Japan K.K.
Sponsor class: INDUSTRY
First posted: 2017-01-26
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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.

Primary outcomes:
measure: Number of Participants With Complications; One of the Following Events
timeFrame: Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later
measure: Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)
timeFrame: 24-month
measure: The Rate of Effective Left Atrial Appendage (LAA) Closure
timeFrame: 45-day, 6-month, 12-month
Secondary outcomes:
measure: Number of Participants With Major Bleeding
timeFrame: 24-month
measure: Number of Participants With Clinically Overt Non-fatal Bleeding
timeFrame: 24-month
measure: Number of Participants With Ischemic Stroke or Systemic Embolism
timeFrame: 24-month
Other outcomes:
measure: Technical Success Rate
timeFrame: Implant Day
measure: Warfarin Discontinuation Rate
timeFrame: 45-day, 6-month, 12-month
Locations:
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Kamakura-city
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Medical Hospital
state: Tokyo
city: Fuchu
country: Japan
facility: Sakakibara Heart Institute
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
Study officials:
affiliation: Tsukuba University Hospital
name: Kazutaka Aonuma
role: PRINCIPAL_INVESTIGATOR
affiliation: Shonankamakura General Hospital
name: Shigeru Saito
role: PRINCIPAL_INVESTIGATOR
References:
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.