Trial Outcomes & Findings for A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W (NCT NCT03033134)

Last Updated: 2020-07-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later

Results posted on

2020-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Implant (ITT) BSJ003W implant group (ITT) : 42 subjects	Roll-in 12 Roll-in subjects
Overall Study STARTED	42	12
Overall Study 6-month Primary Endpoints	42	12
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	42	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implant (ITT) n=42 Participants Implant (ITT) group: 42 subjects	Roll-in n=12 Participants Roll-in group: 12 subjects	Total n=54 Participants Total of all reporting groups
Age, Continuous	72.5 years STANDARD_DEVIATION 8.8 • n=5 Participants	70.6 years STANDARD_DEVIATION 7.4 • n=7 Participants	72.1 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	10 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	42 Participants n=5 Participants	12 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	42 participants n=5 Participants	12 participants n=7 Participants	54 participants n=5 Participants
CHA2DS2-VASc score	3.6 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	3.5 units on a scale STANDARD_DEVIATION 1.6 • n=7 Participants	3.6 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants
Atrial Fibrillation pattern Documented Paroxysmal	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
Atrial Fibrillation pattern Documented Persistent	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Atrial Fibrillation pattern Documented Permanent	18 Participants n=5 Participants	4 Participants n=7 Participants	22 Participants n=5 Participants
HAS-BLED score	2.9 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants	3.1 units on a scale STANDARD_DEVIATION 1.1 • n=7 Participants	3.0 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later

Outcome measures

Outcome measures
Measure	Implant (ITT) n=42 Participants Implant (ITT) group: 42 subjects	Roll-in n=12 Participants Roll-in cohort
Number of Participants With Complications; One of the Following Events	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 24-month

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

The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant

Outcome measures

Outcome measures
Measure	Implant (ITT) n=42 Participants Implant (ITT) group: 42 subjects	Roll-in n=12 Participants Roll-in cohort
Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause) Systemic embolism	0 Participants	0 Participants
Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause) Ischemic stroke	3 Participants	1 Participants
Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause) Hemorrhagic stroke	0 Participants	0 Participants
Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause) Cardiovascular death	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 45-day, 6-month, 12-month

Population: 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

The effective LAA closure is defined as peri-device flow \<= 5mm demonstrated by TEE. TEE measurements will be assessed by an independent Core Laboratory.

Outcome measures

Outcome measures
Measure	Implant (ITT) n=42 Participants Implant (ITT) group: 42 subjects	Roll-in n=12 Participants Roll-in cohort
The Rate of Effective Left Atrial Appendage (LAA) Closure At 45-day	42 Participants	12 Participants
The Rate of Effective Left Atrial Appendage (LAA) Closure At 6-month	42 Participants	11 Participants
The Rate of Effective Left Atrial Appendage (LAA) Closure At 12-month	41 Participants	11 Participants

SECONDARY outcome

Timeframe: 24-month

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

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

Outcome measures

Outcome measures
Measure	Implant (ITT) n=42 Participants Implant (ITT) group: 42 subjects	Roll-in n=12 Participants Roll-in cohort
Number of Participants With Major Bleeding	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 24-month

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

Outcome measures

Outcome measures
Measure	Implant (ITT) n=42 Participants Implant (ITT) group: 42 subjects	Roll-in n=12 Participants Roll-in cohort
Number of Participants With Clinically Overt Non-fatal Bleeding	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 24-month

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

The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later)

Outcome measures

Outcome measures
Measure	Implant (ITT) n=42 Participants Implant (ITT) group: 42 subjects	Roll-in n=12 Participants Roll-in cohort
Number of Participants With Ischemic Stroke or Systemic Embolism Ischemic stroke	3 Participants	1 Participants
Number of Participants With Ischemic Stroke or Systemic Embolism Systemic embolism	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Implant Day

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

Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.

Outcome measures

Outcome measures
Measure	Implant (ITT) n=42 Participants Implant (ITT) group: 42 subjects	Roll-in n=12 Participants Roll-in cohort
Technical Success Rate	42 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 45-day, 6-month, 12-month

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

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.

Outcome measures

Outcome measures
Measure	Implant (ITT) n=42 Participants Implant (ITT) group: 42 subjects	Roll-in n=12 Participants Roll-in cohort
Warfarin Discontinuation Rate At 45-day	41 Participants	12 Participants
Warfarin Discontinuation Rate At 6-month	40 Participants	11 Participants
Warfarin Discontinuation Rate At 12-month	39 Participants	10 Participants

Adverse Events

Implant (ITT)

Serious events: 13 serious events

Other events: 31 other events

Deaths: 1 deaths

Roll-in

Serious events: 6 serious events

Other events: 11 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Implant (ITT) n=42 participants at risk Implant (ITT) group: 42 subjects	Roll-in n=12 participants at risk Roll-in cohort: 12 subjects
General disorders Head, Eyes, Ears, Nose, Throat (Heent)	31.0% 13/42 • Number of events 19 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	50.0% 6/12 • Number of events 11 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Gastrointestinal disorders Gastrointestinal	19.0% 8/42 • Number of events 12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	8.3% 1/12 • Number of events 3 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Skin and subcutaneous tissue disorders Integumentary	14.3% 6/42 • Number of events 10 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	33.3% 4/12 • Number of events 4 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary	19.0% 8/42 • Number of events 9 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Nervous system disorders Neurological	9.5% 4/42 • Number of events 5 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Investigations Abnormal Laboratory Values	7.1% 3/42 • Number of events 4 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	16.7% 2/12 • Number of events 3 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Endocrine disorders Endocrine	7.1% 3/42 • Number of events 3 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal	9.5% 4/42 • Number of events 4 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	16.7% 2/12 • Number of events 2 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Infections and infestations Fever and/or Virus	7.1% 3/42 • Number of events 3 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	8.3% 1/12 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.

Additional Information

Yutaka Gomi

Boston Scientific Japan

Phone: +81.3.6853.7500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Implant (ITT) n=42 participants at risk Implant (ITT) group: 42 subjects	Roll-in n=12 participants at risk Roll-in cohort: 12 subjects
Respiratory, thoracic and mediastinal disorders Dyspnea - Heart Failure	4.8% 2/42 • Number of events 3 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Renal and urinary disorders Renal	2.4% 1/42 • Number of events 2 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Blood and lymphatic system disorders Device Thrombus Atrial Facing - Post Procedure	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Endocrine disorders Endocrine	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Blood and lymphatic system disorders Major Bleed Requiring Transfusion	2.4% 1/42 • Number of events 2 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Nervous system disorders Stroke (Ischemic)	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	8.3% 1/12 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Gastrointestinal disorders Gastrointestinal Bleeding	0.00% 0/42 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	8.3% 1/12 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Cardiac disorders Pericarditis - Unrelated (Non Study) Procedure Or Device	0.00% 0/42 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	8.3% 1/12 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Cardiac disorders Sinus Bradycardia	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Cardiac disorders Coronary Artery Disease	4.8% 2/42 • Number of events 2 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Cardiac disorders Multiple Heart Failure Symptoms	4.8% 2/42 • Number of events 2 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Blood and lymphatic system disorders Anemia	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Cardiac disorders Cardiac Arrest	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Cardiac disorders Chest Pain - Other	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Nervous system disorders Cranial Bleed - Without Stroke	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	8.3% 1/12 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
General disorders Dizziness	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
General disorders Head, Eyes, Ears, Norse, Throat (HEENT)	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Cardiac disorders Heart Failure Symptoms - Unspecified	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Vascular disorders Hematoma	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
General disorders Led to Death	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Infections and infestations Systemic Infection	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Cardiac disorders Torsades Des Pointes	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Nervous system disorders Transient Ischemic Attack (TIA)	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Cardiac disorders Vetricular Tachycardia (VT) / Monomorphic VT	2.4% 1/42 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	0.00% 0/12 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Cardiac disorders Chest Pain - Heart Failure	0.00% 0/42 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	8.3% 1/12 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
General disorders Death	0.00% 0/42 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	8.3% 1/12 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
Gastrointestinal disorders Gastrointestinal	0.00% 0/42 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.	8.3% 1/12 • Number of events 1 • 2 years Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.