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

Atrial Fibrillation Non-Rheumatic Clinical Trial

— SALUTE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033134
• Other study ID #: S6001
• Status: Completed
• Phase: N/A
• Start date: February 27, 2017
• Est. completion date: September 5, 2019

Study information

• Verified date: January 2020
• Source: Boston Scientific Japan K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 5, 2019
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Non-Rheumatic

Intervention

Device:
• BSJ003W
BSJ003W implant

Locations

Country	Name	City	State
Japan	Tokyo Medical and Dental University Medical Hospital	Bunkyo-ku	Tokyo
Japan	Sakakibara Heart Institute	Fuchu	Tokyo
Japan	Shonan Kamakura General Hospital	Kamakura-city	Kanagawa
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Toho University Ohashi Medical Center	Meguro-ku	Tokyo
Japan	Iwate Medical University Hospital	Morioka	Iwate
Japan	Sendai Kousei Hospital	Sendai	Miyagi
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Japan	National Cerebral and Cardiovascular Center	Suita	Osaka
Japan	University of Tsukuba Hospital	Tsukuba	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Japan K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Technical Success Rate	Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.	Implant Day
Other	Warfarin Discontinuation Rate	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.	45-day, 6-month, 12-month
Primary	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
Primary	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
Primary	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	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	24-month
Secondary	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	24-month
Secondary	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)	24-month