Trial Outcomes & Findings for Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing (NCT NCT04798768)
NCT ID: NCT04798768
Last Updated: 2025-11-10
Results Overview
Major EMPOWER MPS System- and Procedure-related Complication-Free Rate Subjects will be assessed for safety issues related to the procedure or system through 6 months post implant
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
297 participants
Primary outcome timeframe
Implant through 6 Months Post-Implant
Results posted on
2025-11-10
Participant Flow
Participant milestones
| Measure |
Patients Implanted With S-ICD and Leadless Cardiac Pacemaker
Patients implanted with an S-ICD and leadless cardiac pacemaker that complete intended testing based on the study protocol
mCRM Therapy System: Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.
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|---|---|
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Overall Study
STARTED
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297
|
|
Overall Study
Implanted With mCRM Therapy System or Attempt or Partial Implant
|
288
|
|
Overall Study
Implanted With mCRM Therapy System or Attempt
|
287
|
|
Overall Study
Implanted With mCRM Therapy System
|
286
|
|
Overall Study
Interim Analysis Cohort
|
162
|
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Overall Study
CE Mark Cohort
|
117
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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297
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
Baseline characteristics by cohort
| Measure |
MODULAR ATP Study Participants
n=297 Participants
Patients consented to receive the mCRM Therapy System which consists of the EMPOWER Leadless Pacemaker and an EMBLEM S-ICD upgraded with investigational firmware
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|---|---|
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Age, Continuous
|
59 Years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
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Sex: Female, Male
Male
|
245 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Caucasian
|
177 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not disclosed
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
11 Participants
n=5 Participants
|
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Region of Enrollment
Canada
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16 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
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12 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
180 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=5 Participants
|
|
Region of Enrollment
France
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
20 participants
n=5 Participants
|
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BMI
|
29.7 kg/m^2
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
LVEF
|
35.3 percent
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
NYHA Classification
Class I
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88 Participants
n=5 Participants
|
|
NYHA Classification
Class II
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146 Participants
n=5 Participants
|
|
NYHA Classification
Class III
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61 Participants
n=5 Participants
|
|
NYHA Classification
Class IV
|
2 Participants
n=5 Participants
|
|
Prevention status
Primary Prevention
|
170 Participants
n=5 Participants
|
|
Prevention status
Secondary Prevention
|
127 Participants
n=5 Participants
|
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Ischemic cardiomyopathy
|
182 Participants
n=5 Participants
|
|
Non-ischemic cardiomyopathy
|
93 Participants
n=5 Participants
|
|
Diabetes
|
108 Participants
n=5 Participants
|
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Renal dysfunction
|
47 Participants
n=5 Participants
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Hyperlipidemia
|
181 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Implant through 6 Months Post-ImplantMajor EMPOWER MPS System- and Procedure-related Complication-Free Rate Subjects will be assessed for safety issues related to the procedure or system through 6 months post implant
Outcome measures
| Measure |
Interim Analysis Cohort
n=162 Participants
This subject cohort was determined by the point in time at which 134 subjects (pre-specified in the endpoint design) had a 6 Month Visit with data submitted in the database. Once the 134th subject that fulfilled that requirement was identified, their EMPOWER LP implant date was used to determine the cohort. Any subject with an EMPOWER LP implant or attempted EMPOWER LP implant on or before the identified implant date is included, even if their 6-month follow-up was after the identified subject. This resulted in 162 subjects to be included in the Interim Analysis Cohort.
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|---|---|
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Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months
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97.5 % of subjects free from complication
Interval 92.5 to
One-sided test was performed with 1.2% alpha. Lower one-sided 98.8% confidence limit was compared to performance goal of 86%. It was pre-specified to only calculate the lower confidence interval.
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PRIMARY outcome
Timeframe: Implant through 12 Months Post-ImplantMajor EMPOWER MPS System- and Procedure-related Complication-free Rate Subjects will be assessed for safety issues related to the procedure or system through 12 months post implant
Outcome measures
| Measure |
Interim Analysis Cohort
n=117 Participants
This subject cohort was determined by the point in time at which 134 subjects (pre-specified in the endpoint design) had a 6 Month Visit with data submitted in the database. Once the 134th subject that fulfilled that requirement was identified, their EMPOWER LP implant date was used to determine the cohort. Any subject with an EMPOWER LP implant or attempted EMPOWER LP implant on or before the identified implant date is included, even if their 6-month follow-up was after the identified subject. This resulted in 162 subjects to be included in the Interim Analysis Cohort.
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|---|---|
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Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months
|
98.3 % of subjects free from complication
Interval 93.3 to
One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 81%. It was pre-specified to only calculate the lower confidence interval.
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PRIMARY outcome
Timeframe: At the 6 Month Follow-upPopulation: Number of subjects in the interim analysis cohort who underwent S-ICD to EMPOWER LP communication testing at 6 months in at least one of four postures. Results were adjusted using a repeated measures logistic regression model
Communication Success between the S-ICD and EMPOWER PG Data from subjects will be assessed for effectiveness of communication between S-ICD and the EMPOWER PG by evaluating if a paced beat is present during communication testing in four postures: upright, supine, and right and left side.
Outcome measures
| Measure |
Interim Analysis Cohort
n=589 Postures
This subject cohort was determined by the point in time at which 134 subjects (pre-specified in the endpoint design) had a 6 Month Visit with data submitted in the database. Once the 134th subject that fulfilled that requirement was identified, their EMPOWER LP implant date was used to determine the cohort. Any subject with an EMPOWER LP implant or attempted EMPOWER LP implant on or before the identified implant date is included, even if their 6-month follow-up was after the identified subject. This resulted in 162 subjects to be included in the Interim Analysis Cohort.
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|---|---|
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Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG
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98.8 Adjusted % with successful communication
Interval 97.0 to
One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 88%. It was pre-specified to only calculate the lower confidence interval.
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PRIMARY outcome
Timeframe: At the 6 Month Follow-upPopulation: Number of subjects in the interim analysis cohort with Pacing Capture Threshold data at 6 months
Proportion of Subjects with Adequate Pacing Capture Threshold Effectiveness will be confirmed by evaluating the percentage of subjects considered to be a PCT Responder, defined as a subject with a PCT measurement of ≤ 2.0 V @ 0.4 ms pulse width
Outcome measures
| Measure |
Interim Analysis Cohort
n=151 Participants
This subject cohort was determined by the point in time at which 134 subjects (pre-specified in the endpoint design) had a 6 Month Visit with data submitted in the database. Once the 134th subject that fulfilled that requirement was identified, their EMPOWER LP implant date was used to determine the cohort. Any subject with an EMPOWER LP implant or attempted EMPOWER LP implant on or before the identified implant date is included, even if their 6-month follow-up was after the identified subject. This resulted in 162 subjects to be included in the Interim Analysis Cohort.
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|---|---|
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Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder
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97.4 % of subjects with PCT <= 2V @ 0.4 ms
Interval 93.4 to
One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 80%. It was pre-specified to only calculate the lower confidence interval.
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SECONDARY outcome
Timeframe: At the 3 Month VisitPopulation: Data for this endpoint were obtained from the subset of subjects who consented into the substudy and performed treadmill testing at 3 months
Metabolic-Chronotropic Relation Slope (MCR Slope) from the Kay-Wilkoff Model Using the Kay-Wilkoff model, data will be assessed to evaluate the proportionality of the EMPOWER PG's sensor-indicated rate to the subject's workload during the treadmill test
Outcome measures
| Measure |
Interim Analysis Cohort
n=35 Participants
This subject cohort was determined by the point in time at which 134 subjects (pre-specified in the endpoint design) had a 6 Month Visit with data submitted in the database. Once the 134th subject that fulfilled that requirement was identified, their EMPOWER LP implant date was used to determine the cohort. Any subject with an EMPOWER LP implant or attempted EMPOWER LP implant on or before the identified implant date is included, even if their 6-month follow-up was after the identified subject. This resulted in 162 subjects to be included in the Interim Analysis Cohort.
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|---|---|
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Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test
|
0.96 Beta coefficient
Interval 0.91 to 1.02
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SECONDARY outcome
Timeframe: Implant through 2 years post-implantAll-Cause Survival; data not reported as it is still being collected
Outcome measures
Outcome data not reported
Adverse Events
MODULAR ATP Study Participants
Serious events: 113 serious events
Other events: 86 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
MODULAR ATP Study Participants
n=288 participants at risk
All-cause mortality evaluated in all enrolled participants (N=297). Adverse events were evaluated for participants implanted or attempted with the mCRM Therapy System (S-ICD after study enrollment, and/ or the EMPOWER LP), N=288. Individual adverse event categories evaluated in participants at risk for that event category (287 Leadless Cardiac Pacemaker, 9 TV Lead Extraction Procedure, 288 remaining adverse event categories).
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|---|---|
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Blood and lymphatic system disorders
Non-cardiovascular
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0.35%
1/288 • Number of events 1 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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Cardiac disorders
Cardiovascular
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18.8%
54/288 • Number of events 86 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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Endocrine disorders
Non-cardiovascular
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2.1%
6/288 • Number of events 7 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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Gastrointestinal disorders
Non-cardiovascular
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1.7%
5/288 • Number of events 6 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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General disorders
Cardiovascular
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2.4%
7/288 • Number of events 9 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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General disorders
Non-cardiovascular
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3.5%
10/288 • Number of events 13 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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|
Infections and infestations
Non-cardiovascular
|
4.5%
13/288 • Number of events 17 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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Injury, poisoning and procedural complications
Leadless Cardiac Pacemaker - Procedure
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4.5%
13/287 • Number of events 16 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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Injury, poisoning and procedural complications
S-ICD Defibrillation and Conversion Testing
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0.69%
2/288 • Number of events 3 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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Injury, poisoning and procedural complications
S-ICD System Patient Related
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0.69%
2/288 • Number of events 2 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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Injury, poisoning and procedural complications
S-ICD System Procedure
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2.4%
7/288 • Number of events 8 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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Injury, poisoning and procedural complications
TV Lead Extraction Procedure
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22.2%
2/9 • Number of events 4 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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Nervous system disorders
Non-cardiovascular
|
0.69%
2/288 • Number of events 2 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
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Product Issues
Leadless Cardiac Pacemaker - Right Ventricle - Brady
|
0.35%
1/287 • Number of events 1 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Product Issues
Modular System (LCP+S-ICD)
|
0.69%
2/288 • Number of events 2 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Product Issues
S-ICD Electrode
|
1.0%
3/288 • Number of events 3 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Product Issues
S-ICD PG
|
0.69%
2/288 • Number of events 2 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Product Issues
S-ICD System Diagnosis
|
0.69%
2/288 • Number of events 2 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Product Issues
S-ICD System Therapy
|
3.1%
9/288 • Number of events 9 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Renal and urinary disorders
Non-cardiovascular
|
3.1%
9/288 • Number of events 12 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiovascular
|
4.2%
12/288 • Number of events 13 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Skin and subcutaneous tissue disorders
Non-cardiovascular
|
0.69%
2/288 • Number of events 2 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Vascular disorders
Cardiovascular
|
5.6%
16/288 • Number of events 17 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
Other adverse events
| Measure |
MODULAR ATP Study Participants
n=288 participants at risk
All-cause mortality evaluated in all enrolled participants (N=297). Adverse events were evaluated for participants implanted or attempted with the mCRM Therapy System (S-ICD after study enrollment, and/ or the EMPOWER LP), N=288. Individual adverse event categories evaluated in participants at risk for that event category (287 Leadless Cardiac Pacemaker, 9 TV Lead Extraction Procedure, 288 remaining adverse event categories).
|
|---|---|
|
Cardiac disorders
Cardiovascular
|
8.7%
25/288 • Number of events 29 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Endocrine disorders
Non-cardiovascular
|
0.35%
1/288 • Number of events 1 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Gastrointestinal disorders
Non-cardiovascular
|
0.35%
1/288 • Number of events 1 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
General disorders
Cardiovascular
|
2.8%
8/288 • Number of events 9 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
General disorders
Non-cardiovascular
|
1.4%
4/288 • Number of events 4 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
General disorders
S-ICD System Patient Related
|
0.69%
2/288 • Number of events 2 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Infections and infestations
Non-cardiovascular
|
0.35%
1/288 • Number of events 1 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Injury, poisoning and procedural complications
Leadless Cardiac Pacemaker - Procedure
|
4.2%
12/287 • Number of events 12 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Injury, poisoning and procedural complications
Leadless Cardiac Pacemaker - Right Ventricle - Brady
|
0.35%
1/287 • Number of events 1 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Injury, poisoning and procedural complications
S-ICD Defibrillation and Conversion Testing
|
0.35%
1/288 • Number of events 1 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Injury, poisoning and procedural complications
S-ICD System Patient Related
|
0.69%
2/288 • Number of events 2 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Injury, poisoning and procedural complications
S-ICD System Procedure
|
5.6%
16/288 • Number of events 18 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Musculoskeletal and connective tissue disorders
Non-cardiovascular
|
0.35%
1/288 • Number of events 1 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Product Issues
Modular System (LCP+S-ICD)
|
0.69%
2/288 • Number of events 2 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Product Issues
S-ICD Electrode
|
0.35%
1/288 • Number of events 1 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Product Issues
S-ICD PG
|
0.69%
2/288 • Number of events 2 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Product Issues
S-ICD System Therapy
|
3.1%
9/288 • Number of events 10 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
|
Vascular disorders
Cardiovascular
|
1.4%
4/288 • Number of events 4 • Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall submit publication to Sponsor for review at least 60 days prior to submission. Sponsor reserves the right to delete any confidential info or other proprietary info of Sponsor (not incl. Results). Sponsor may extend 90 days to protect its intellectual property (IP) interests. PI shall be free to publish the results of the study after: Initial Publication is published; notification by Sponsor that Initial Publication is no longer planned; or 12 mo. after the expiration date at all sites
- Publication restrictions are in place
Restriction type: OTHER