Trial Outcomes & Findings for S-ICD® System Post Approval Study (NCT NCT01736618)
NCT ID: NCT01736618
Last Updated: 2024-03-18
Results Overview
Type I complications are adverse events caused by a component of the S-ICD System (i.e. pulse generator, electrode, EIT or programmer) that results in permanent loss of device function, invasive intervention or death.
Recruitment status
COMPLETED
Target enrollment
1766 participants
Primary outcome timeframe
60 months (1800 days)
Results posted on
2024-03-18
Participant Flow
Participant milestones
| Measure |
S-ICD System Implant Attempt
All subjects undergo an S-ICD System implant procedure.
|
|---|---|
|
Overall Study
STARTED
|
1766
|
|
Overall Study
COMPLETED
|
767
|
|
Overall Study
NOT COMPLETED
|
999
|
Reasons for withdrawal
| Measure |
S-ICD System Implant Attempt
All subjects undergo an S-ICD System implant procedure.
|
|---|---|
|
Overall Study
Death
|
294
|
|
Overall Study
Lost to Follow-up
|
193
|
|
Overall Study
Withdrawal by Subject
|
54
|
|
Overall Study
Subject unable to be followed at study location
|
223
|
|
Overall Study
Physician Decision
|
33
|
|
Overall Study
Transplant or removal of target organ
|
19
|
|
Overall Study
Change in indication or condition
|
78
|
|
Overall Study
Study device explant
|
103
|
|
Overall Study
Unable to complete implant
|
2
|
Baseline Characteristics
EF was only available for 1714 participants.
Baseline characteristics by cohort
| Measure |
S-ICD System Implant Attempt
n=1766 Participants
All subjects undergo an S-ICD System implant procedure.
|
|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 15.0 • n=1766 Participants
|
|
Sex: Female, Male
Female
|
542 Participants
n=1766 Participants
|
|
Sex: Female, Male
Male
|
1224 Participants
n=1766 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Caucasian
|
1048 Participants
n=1766 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Black, of African heritage
|
508 Participants
n=1766 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Hispanic or Latino
|
104 Participants
n=1766 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Asian
|
22 Participants
n=1766 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · American Indian or Alaska Native
|
16 Participants
n=1766 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Native Hawaiian or other Pacific Islander
|
8 Participants
n=1766 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Other
|
5 Participants
n=1766 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Multi-racial
|
9 Participants
n=1766 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Not Disclosed
|
46 Participants
n=1766 Participants
|
|
Region of Enrollment
United States
|
1766 participants
n=1766 Participants
|
|
Device Indication
Primary prevention
|
1359 Participants
n=1766 Participants
|
|
Device Indication
Secondary prevention
|
407 Participants
n=1766 Participants
|
|
Left Ventricular Ejection Fraction
|
32.3 % of LV volume ejected per heart beat
STANDARD_DEVIATION 14.6 • n=1714 Participants • EF was only available for 1714 participants.
|
|
Body Mass Index
|
29.9 kg/m^2
STANDARD_DEVIATION 7.6 • n=1762 Participants • BMI was only available for 1762 participants
|
|
History of Atrial Fibrillation
|
732 Participants
n=1760 Participants • Atrial Fibrillation was only available for 1760 participants.
|
|
History of Hypertension
|
1089 Participants
n=1760 Participants • Hypertension was only available for 1760 participants.
|
|
History of Diabetes
|
592 Participants
n=1760 Participants • Diabetes history was only available for 1760 participants.
|
|
History of Myocardial Infarction
|
582 Participants
n=1737 Participants • History of Myocardial Infarction was only available for 1737 participants.
|
|
History of Kidney Disease
|
432 Participants
n=1760 Participants • History of Kidney Disease was only available for 1760 participants.
|
|
Creatinine Level
|
1.8 mg/dL
STANDARD_DEVIATION 2.2 • n=1629 Participants • Creatinine level was only available for 1629 participants.
|
|
History of Cancer
|
28 Participants
n=1760 Participants • History of Cancer was only available for 1760 participants.
|
|
History of Coronary Artery Bypass Graft (CABG)
|
284 Participants
n=1752 Participants • History of CABG was only available for 1752 participants.
|
|
History of Percutaneous Revascularization
|
484 Participants
n=1744 Participants • History of Percutaneous Revascularization was only available for 1744 participants.
|
PRIMARY outcome
Timeframe: 60 months (1800 days)Population: S-ICD PAS enrolled de novo implant subjects as well as prior IDE participants. Primary Safety endpoint includes subjects enrolled in S-ICD PAS combined with the subjects from the S-ICD IDE (NCT# 01064076). S-ICD PAS had 1643 de novo implant attempts and 123 prior IDE implant subjects, for endpoint analyses this was combined with the data from the 198 IDE implant attempt subjects that did not participate in S-ICD PAS, totaling 1964 subjects.
Type I complications are adverse events caused by a component of the S-ICD System (i.e. pulse generator, electrode, EIT or programmer) that results in permanent loss of device function, invasive intervention or death.
Outcome measures
| Measure |
S-ICD System Implant Attempt
n=1964 Participants
All subjects undergo an S-ICD System implant procedure.
|
|---|---|
|
Number of Participants Free From Type I Complication
|
1869 Participants
|
PRIMARY outcome
Timeframe: 60 months (1825 days)Population: Primary effectiveness endpoint includes subjects in S-ICD PAS combined with the subjects from the S-ICD IDE (NCT# 01064076). S-ICD PAS had 1637 de novo implants and 123 prior IDE implant subjects, for endpoint analyses this was combined with the data from the 191 IDE implanted subjects that did not participate in S-ICD PAS, totaling 1951 subjects. This endpoint analyzes all appropriate shocks.
Overall shock effectiveness refers to conversion of an episode following on any of the 5 shocks (maximum) that may be delivered during a single episode. Discrete episodes of VT/VF are those that are temporally independent (\<3 within a 24 hour period), unlike storm episodes, which occur in clusters (≥3 episodes within a 24 hour period). Episodes that spontaneously terminate will be excluded from this endpoint since the effectiveness of the shock cannot be evaluated in such circumstances.
Outcome measures
| Measure |
S-ICD System Implant Attempt
n=512 S-ICD Shocks
All subjects undergo an S-ICD System implant procedure.
|
|---|---|
|
Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF
|
505 S-ICD Shocks
|
SECONDARY outcome
Timeframe: 60 months (1800 days)Population: Secondary safety endpoint includes subjects in S-ICD PAS combined with the subjects from the S-ICD IDE (NCT# 01064076). S-ICD PAS had 1643 de novo implant attempts and 123 prior IDE implant subjects, for endpoint analyses this was combined with the data from the 198 IDE implant attempt subjects that did not participate in S-ICD PAS, totaling 1964 subjects.
The electrode related complications analyzed for this end-point include: complications occurring less than or equal to 30 days post implant that are attributable to structural electrode failure for electrode movement, electrode impendence out of range, electrode conductor fracture, deformation or breakage or insulation failure; OR occurring greater than 30 days post implant regardless of structural failure for electrode movement, electrode impendence out of range, electrode conductor fracture, deformation/breakage or insulation failure; OR occurring greater than 30 days post implant attributable to structural electrode failure for incomplete/improper header connection, in-subject damage to electrode, electrode revision to optimize therapy, electrode movement, infection, oversensing/undersensing. Additionally, a complication is an adverse event that results in permanent loss of device function, invasive intervention or death.
Outcome measures
| Measure |
S-ICD System Implant Attempt
n=1964 Participants
All subjects undergo an S-ICD System implant procedure.
|
|---|---|
|
Number of Participants Free From Electrode-related Complications
|
1953 Participants
|
SECONDARY outcome
Timeframe: 60 months (1825 days)Population: The secondary effectiveness endpoint includes subjects in S-ICD PAS combined with the subjects from the S-ICD IDE (NCT# 01064076). S-ICD PAS had 1637 de novo implants and 123 prior IDE implant subjects, for endpoint analyses this was combined with the data from the 191 IDE implanted subjects that did not participate in S-ICD PAS, totaling 1951 subjects. This endpoint analyzes all induced (acute) or spontaneous appropriately treated discrete VT/VF shocks.
The rate in first shock effectiveness in converting induced (acute) and spontaneous discrete episodes of VT/VF through 60 months (1825 days) is calculated as the number of successful first shock conversions divided by the total evaluable episodes Acute Tests included: S-ICD PAS Study: Acute tests include induced episodes during the initial implant hospitalization after enrollment. Inductions may have been done on different days, but all occurred before the patient was discharged after initial implant; IDE Study : Acute tests included induced episodes occurring during the initial implant procedure as well as subsequent hospitalization until the final system position was obtained. * Acute Test Shock Energy Levels included all energy levels in the PAS Study and only 65 Joule shocks in the IDE Study. * Acute Test Arrhythmias included all VT and VF episodes for the PAS Study and only VF episodes for the IDE Study.
Outcome measures
| Measure |
S-ICD System Implant Attempt
n=2195 S-ICD Shocks
All subjects undergo an S-ICD System implant procedure.
|
|---|---|
|
First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF
|
2071 S-ICD Shocks
|
Adverse Events
S-ICD System Implant Attempt
Serious events: 638 serious events
Other events: 247 other events
Deaths: 294 deaths
Serious adverse events
| Measure |
S-ICD System Implant Attempt
n=1766 participants at risk
All subjects undergo an S-ICD System implant procedure.
|
|---|---|
|
Cardiac disorders
Heart Failure (HF)/ Worsening HF
|
3.6%
63/1766 • Number of events 68 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Worsening VT/VF
|
2.8%
50/1766 • Number of events 55 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Chest Pain - Cardiovascular related
|
1.4%
25/1766 • Number of events 26 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Cardiac Arrest
|
1.4%
25/1766 • Number of events 25 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Atrial Fibrillation / Atrial Flutter
|
1.3%
23/1766 • Number of events 24 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Bradycardia/ AV Block
|
1.2%
21/1766 • Number of events 21 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Pulseless Electrical Activity (PEA)
|
1.1%
20/1766 • Number of events 20 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Cardiogenic Shock
|
0.85%
15/1766 • Number of events 16 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Other -Cardiovascular related
|
0.45%
8/1766 • Number of events 8 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Palpitations
|
0.11%
2/1766 • Number of events 2 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Premature Ventricular Contractions (PVC)
|
0.11%
2/1766 • Number of events 2 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Supraventricular Tachycardia (SVT)
|
0.11%
2/1766 • Number of events 2 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Angina
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Aortic Stenosis
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Inflammation - Cardiovascular related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.34%
6/1766 • Number of events 8 • Data was collected over a 60 month (5-year) follow-up period
|
|
General disorders
Multisystem Failure - Other
|
3.0%
53/1766 • Number of events 53 • Data was collected over a 60 month (5-year) follow-up period
|
|
General disorders
Death - unknown cause
|
2.2%
38/1766 • Number of events 38 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Syncope - Cardiovascular
|
0.62%
11/1766 • Number of events 12 • Data was collected over a 60 month (5-year) follow-up period
|
|
Cardiac disorders
Near Syncope/Dizziness/Shortness of Breath/Confusion
|
0.11%
2/1766 • Number of events 2 • Data was collected over a 60 month (5-year) follow-up period
|
|
General disorders
Syncope - Non-cardiovascular
|
0.40%
7/1766 • Number of events 8 • Data was collected over a 60 month (5-year) follow-up period
|
|
General disorders
Chest pain - Non-cardiac other
|
0.34%
6/1766 • Number of events 7 • Data was collected over a 60 month (5-year) follow-up period
|
|
General disorders
Abnormal Laboratory Values
|
0.23%
4/1766 • Number of events 5 • Data was collected over a 60 month (5-year) follow-up period
|
|
General disorders
Multiple Symptoms
|
0.11%
2/1766 • Number of events 2 • Data was collected over a 60 month (5-year) follow-up period
|
|
General disorders
Near Syncope/Dizziness/Shortness of Breath/Confusion
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
General disorders
Other - Patient Condition - Non-cardiovascular
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Infections and infestations
Infection - Non-device/procedure related
|
2.8%
49/1766 • Number of events 51 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Infection - S-ICD System/Implant Procedure related
|
2.5%
45/1766 • Number of events 45 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Hematoma <= 30 days post-implant - Procedure related
|
0.68%
12/1766 • Number of events 12 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Infection - Incisional/Superficial Infection - Procedure related
|
0.57%
10/1766 • Number of events 10 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Adverse Reaction - Hypotension - Procedure related
|
0.51%
9/1766 • Number of events 9 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Discomfort - Post-op > 30-Days - Device related
|
0.28%
5/1766 • Number of events 5 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Sub-optimal Electrode Position - Procedure related
|
0.23%
4/1766 • Number of events 4 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Adverse Reaction to Medications - Procedure related
|
0.17%
3/1766 • Number of events 3 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Elective Device Replacement
|
0.17%
3/1766 • Number of events 3 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Electrode Movement - Procedure related
|
0.17%
3/1766 • Number of events 3 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Inadequate healing of incision site - Procedure related
|
0.17%
3/1766 • Number of events 3 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Trauma - Other
|
0.17%
3/1766 • Number of events 3 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Cardiac arrest - Procedure related
|
0.11%
2/1766 • Number of events 2 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Electrode movement - Electrode related
|
0.11%
2/1766 • Number of events 2 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Respiratory Failure - Procedure related
|
0.11%
2/1766 • Number of events 2 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Adverse Reaction Respiratory - Procedure Related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Bleeding - Procedure related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Fever - Procedure related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Heart Failure / Worsening of Heart Failure - Procedure related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Hematoma - Pocket (> 30 days post-implant)
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Hematoma > 30 days post-implant - Procedure related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
PG movement / Revision - Other
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Pleural Effusion - Procedure related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Pneumothorax - Procedure related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Pulseless Electrical Activity (PEA) Post Anesthesia prior to Implant
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Seroma - Procedure related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Sub-optimal device and electrode position - Procedure related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.85%
15/1766 • Number of events 15 • Data was collected over a 60 month (5-year) follow-up period
|
|
Nervous system disorders
Neurological
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Inappropriate Shock - Inappropriate Sensing: Cardiac Oversensing
|
3.2%
57/1766 • Number of events 64 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Inappropriate Shock - Inappropriate Sensing: Extra-cardiac Oversensing
|
0.68%
12/1766 • Number of events 13 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Inappropriate Shock - Above Programmed Rate Zone
|
0.62%
11/1766 • Number of events 12 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Premature Cell Battery Depletion
|
0.62%
11/1766 • Number of events 11 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Inappropriate Shock - Inappropriate Sensing: Discrimination Error
|
0.34%
6/1766 • Number of events 8 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Unable to Convert - During Device System Implant Procedure
|
0.34%
6/1766 • Number of events 7 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Erosion - Device related
|
0.34%
6/1766 • Number of events 6 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Appropriate Shock - Accelerated Arrhythmia
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Electrode Conductor Fracture- Presumed Twiddler's Syndrome
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Erosion - Electrode related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Erosion - Imminent Erosion - Device related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Inability to Communicate with the Device
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Inappropriate Shock - Inappropriate Sensing: Baseline Shift
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Trauma to Device
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Unable to Convert - During Device Testing Procedure >150 days - Patient condition
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Undersensing - Device related
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Psychiatric disorders
Psychological Disorder
|
0.23%
4/1766 • Number of events 4 • Data was collected over a 60 month (5-year) follow-up period
|
|
Renal and urinary disorders
Kidney Disease
|
0.68%
12/1766 • Number of events 12 • Data was collected over a 60 month (5-year) follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.68%
12/1766 • Number of events 12 • Data was collected over a 60 month (5-year) follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath/Dyspnea
|
0.11%
2/1766 • Number of events 3 • Data was collected over a 60 month (5-year) follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.11%
2/1766 • Number of events 2 • Data was collected over a 60 month (5-year) follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Vascular disorders
Myocardial Infarction
|
1.6%
29/1766 • Number of events 30 • Data was collected over a 60 month (5-year) follow-up period
|
|
Vascular disorders
Stroke
|
1.4%
24/1766 • Number of events 24 • Data was collected over a 60 month (5-year) follow-up period
|
|
Vascular disorders
Coronary Artery Disease
|
0.51%
9/1766 • Number of events 9 • Data was collected over a 60 month (5-year) follow-up period
|
|
Vascular disorders
Bleeding - Other
|
0.23%
4/1766 • Number of events 4 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Stroke - Procedure related
|
0.23%
4/1766 • Number of events 4 • Data was collected over a 60 month (5-year) follow-up period
|
|
Vascular disorders
Thrombosis
|
0.23%
4/1766 • Number of events 4 • Data was collected over a 60 month (5-year) follow-up period
|
|
Vascular disorders
Hypotension
|
0.11%
2/1766 • Number of events 3 • Data was collected over a 60 month (5-year) follow-up period
|
|
Vascular disorders
Peripheral Vascular Disease
|
0.11%
2/1766 • Number of events 3 • Data was collected over a 60 month (5-year) follow-up period
|
|
Vascular disorders
Pulmonary Embolism
|
0.17%
3/1766 • Number of events 3 • Data was collected over a 60 month (5-year) follow-up period
|
|
Vascular disorders
Transient Ischemic Attack (TIA)
|
0.17%
3/1766 • Number of events 3 • Data was collected over a 60 month (5-year) follow-up period
|
|
Vascular disorders
Hypertension
|
0.06%
1/1766 • Number of events 1 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Discomfort - Post-op ≤ 30-Days - Procedure related
|
0.57%
10/1766 • Number of events 10 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Discomfort - Post-op ≤ 30-Days - Device related
|
0.11%
2/1766 • Number of events 2 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Device Movement - Revision
|
0.28%
5/1766 • Number of events 5 • Data was collected over a 60 month (5-year) follow-up period
|
Other adverse events
| Measure |
S-ICD System Implant Attempt
n=1766 participants at risk
All subjects undergo an S-ICD System implant procedure.
|
|---|---|
|
Product Issues
Inappropriate Shock - Inappropriate Sensing: Cardiac Oversensing
|
6.2%
109/1766 • Number of events 134 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Inappropriate Shock - Inappropriate Sensing: Extra-cardiac Oversensing
|
2.6%
46/1766 • Number of events 47 • Data was collected over a 60 month (5-year) follow-up period
|
|
Product Issues
Discomfort - Post-op > 30-Days - Device related
|
1.4%
25/1766 • Number of events 25 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Incisional/Superficial Infection - Procedure related
|
1.4%
24/1766 • Number of events 24 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Hematoma <= 30 days post-implant - Procedure related
|
1.2%
21/1766 • Number of events 21 • Data was collected over a 60 month (5-year) follow-up period
|
|
Injury, poisoning and procedural complications
Discomfort - Post-op ≤ 30-Days - Procedure related
|
1.2%
22/1766 • Number of events 22 • Data was collected over a 60 month (5-year) follow-up period
|
Additional Information
Clinical Trial Manager or Director of Clinical Trials (Cardiology Rhythm Management)
Boston Scientific - Rhythm Management
Phone: 1-800-227-3422
Email: [email protected]
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