Atrial Fibrillation Non-Rheumatic
Conditions
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
Interventions
DEVICEBSJ003W
BSJ003W implant
Sponsors
Boston Scientific Japan K.K.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Effective Left Atrial Appendage (LAA) Closure | 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. |
| Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause) | 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 |
| Number of Participants With Complications; One of the Following Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Ischemic Stroke or Systemic Embolism | 24-month | The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later) |
| Number of Participants With Major Bleeding | 24-month | 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 |
| Number of Participants With Clinically Overt Non-fatal Bleeding | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate | Implant Day | Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary. |
| Warfarin Discontinuation Rate | 45-day, 6-month, 12-month | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implant (ITT) Implant (ITT) group: 42 subjects | 42 |
| Roll-in Roll-in group: 12 subjects | 12 |
| Total | 54 |
Baseline characteristics
| Characteristic | Implant (ITT) | Roll-in | Total |
|---|---|---|---|
| Age, Continuous | 72.5 years STANDARD_DEVIATION 8.8 | 70.6 years STANDARD_DEVIATION 7.4 | 72.1 years STANDARD_DEVIATION 8.5 |
| Atrial Fibrillation pattern Documented Paroxysmal | 15 Participants | 5 Participants | 20 Participants |
| Atrial Fibrillation pattern Documented Permanent | 18 Participants | 4 Participants | 22 Participants |
| Atrial Fibrillation pattern Documented Persistent | 9 Participants | 3 Participants | 12 Participants |
| CHA2DS2-VASc score | 3.6 units on a scale STANDARD_DEVIATION 1.6 | 3.5 units on a scale STANDARD_DEVIATION 1.6 | 3.6 units on a scale STANDARD_DEVIATION 1.6 |
| HAS-BLED score | 2.9 units on a scale STANDARD_DEVIATION 1.1 | 3.1 units on a scale STANDARD_DEVIATION 1.1 | 3.0 units on a scale STANDARD_DEVIATION 1.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 42 Participants | 12 Participants | 54 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 42 participants | 12 participants | 54 participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 35 Participants | 10 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 42 | 1 / 12 |
| other Total, other adverse events | 31 / 42 | 11 / 12 |
| serious Total, serious adverse events | 13 / 42 | 6 / 12 |
Outcome results
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.
Time frame: Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implant (ITT) | Number of Participants With Complications; One of the Following Events | 0 Participants |
| Roll-in | Number of Participants With Complications; One of the Following Events | 0 Participants |
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
Time frame: 24-month
Population: Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Implant (ITT) | 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 |
| Implant (ITT) | 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 |
| Implant (ITT) | 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 |
| Implant (ITT) | 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 |
| Roll-in | Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause) | Cardiovascular death | 0 Participants |
| Roll-in | Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause) | Ischemic stroke | 1 Participants |
| Roll-in | 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 |
| Roll-in | 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 |
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.
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Implant (ITT) | The Rate of Effective Left Atrial Appendage (LAA) Closure | At 45-day | 42 Participants |
| Implant (ITT) | The Rate of Effective Left Atrial Appendage (LAA) Closure | At 6-month | 42 Participants |
| Implant (ITT) | The Rate of Effective Left Atrial Appendage (LAA) Closure | At 12-month | 41 Participants |
| Roll-in | The Rate of Effective Left Atrial Appendage (LAA) Closure | At 45-day | 12 Participants |
| Roll-in | The Rate of Effective Left Atrial Appendage (LAA) Closure | At 6-month | 11 Participants |
| Roll-in | The Rate of Effective Left Atrial Appendage (LAA) Closure | At 12-month | 11 Participants |
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
Time frame: 24-month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implant (ITT) | Number of Participants With Clinically Overt Non-fatal Bleeding | 3 Participants |
| Roll-in | Number of Participants With Clinically Overt Non-fatal Bleeding | 0 Participants |
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)
Time frame: 24-month
Population: Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Implant (ITT) | Number of Participants With Ischemic Stroke or Systemic Embolism | Ischemic stroke | 3 Participants |
| Implant (ITT) | Number of Participants With Ischemic Stroke or Systemic Embolism | Systemic embolism | 0 Participants |
| Roll-in | Number of Participants With Ischemic Stroke or Systemic Embolism | Ischemic stroke | 1 Participants |
| Roll-in | Number of Participants With Ischemic Stroke or Systemic Embolism | Systemic embolism | 0 Participants |
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
Time frame: 24-month
Population: Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implant (ITT) | Number of Participants With Major Bleeding | 2 Participants |
| Roll-in | Number of Participants With Major Bleeding | 2 Participants |
Other Pre-specified
Technical Success Rate
Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.
Time frame: Implant Day
Population: Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implant (ITT) | Technical Success Rate | 42 Participants |
| Roll-in | Technical Success Rate | 12 Participants |
Other Pre-specified
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.
Time frame: 45-day, 6-month, 12-month
Population: Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Implant (ITT) | Warfarin Discontinuation Rate | At 12-month | 39 Participants |
| Implant (ITT) | Warfarin Discontinuation Rate | At 45-day | 41 Participants |
| Implant (ITT) | Warfarin Discontinuation Rate | At 6-month | 40 Participants |
| Roll-in | Warfarin Discontinuation Rate | At 12-month | 10 Participants |
| Roll-in | Warfarin Discontinuation Rate | At 45-day | 12 Participants |
| Roll-in | Warfarin Discontinuation Rate | At 6-month | 11 Participants |