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

NCT03033134 | Completed Results FDA Device

• 1 other identifier: S6001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 10

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

Conditions

Atrial Fibrillation Non-Rheumatic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Number of Participants With Major Bleeding

  24-month

• Number of Participants With Clinically Overt Non-fatal Bleeding

  24-month

• Number of Participants With Ischemic Stroke or Systemic Embolism

  24-month

Other Outcomes (2)

• Technical Success Rate

  Implant Day

• Warfarin Discontinuation Rate

  45-day, 6-month, 12-month

Study Arms (1)

BSJ003W

EXPERIMENTAL

BSJ003W implant group

Device: BSJ003W

Interventions

BSJ003W DEVICE

BSJ003W implant

BSJ003W

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Boston Scientific Japan K.K.: lead

Study Sites (10)

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8255, Japan

Location

University of Tsukuba Hospital

Tsukuba, Ibaraki, 305-8576, Japan

Location

Iwate Medical University Hospital

Morioka, Iwate, 020-8505, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan

Location

Sendai Kousei Hospital

Sendai, Miyagi, 980-0873, Japan

Location

National Cerebral and Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

Tokyo Medical and Dental University Medical Hospital

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Sakakibara Heart Institute

Fuchū, Tokyo, 183-0003, Japan

Location

Toho University Ohashi Medical Center

Meguro-ku, Tokyo, 153-8515, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Related Publications (1)

• 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.

  PMID: 32595176 DERIVED

Results Point of Contact

• Title: Yutaka Gomi
• Organization: Boston Scientific Japan

Yutaka.Gomi@bsci.com

+81.3.6853.7500

Study Officials

• Kazutaka Aonuma

  Tsukuba University Hospital

  PRINCIPAL INVESTIGATOR

• Shigeru Saito

  Shonankamakura General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 26, 2017
• Study Start: February 27, 2017
• Primary Completion: February 1, 2018
• Study Completion: September 5, 2019
• Last Updated: July 14, 2020
• Results First Posted: January 8, 2019

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (10)