Trial Outcomes & Findings for Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry (NCT NCT01085435)
NCT ID: NCT01085435
Last Updated: 2025-05-20
Results Overview
The number of subjects without Type I Complications within 30 Days of Implant divided by the Total Implanted Subjects.
Recruitment status
COMPLETED
Target enrollment
994 participants
Primary outcome timeframe
30 days post implant
Results posted on
2025-05-20
Participant Flow
Participant milestones
| Measure |
EFFORTLESS Main Study
Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.
S-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool.
|
|---|---|
|
Main Study
STARTED
|
994
|
|
Main Study
Baseline
|
984
|
|
Main Study
COMPLETED
|
703
|
|
Main Study
NOT COMPLETED
|
291
|
|
EFFORTLESS Extension Phase Substudy
STARTED
|
203
|
|
EFFORTLESS Extension Phase Substudy
COMPLETED
|
164
|
|
EFFORTLESS Extension Phase Substudy
NOT COMPLETED
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EFFORTLESS Main Study
n=984 Participants
Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.
S-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool.
|
|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 16.8 • n=984 Participants
|
|
Sex: Female, Male
Female
|
275 Participants
n=984 Participants
|
|
Sex: Female, Male
Male
|
709 Participants
n=984 Participants
|
PRIMARY outcome
Timeframe: 30 days post implantPopulation: All implanted patients (N=984)
The number of subjects without Type I Complications within 30 Days of Implant divided by the Total Implanted Subjects.
Outcome measures
| Measure |
Extension Phase Sub Study
n=984 Participants
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Perioperative S-ICD Complication Free Rate
|
983 Participants
|
PRIMARY outcome
Timeframe: Minimum 360 days post implantPopulation: All implanted patients (N=984)
The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications.
Outcome measures
| Measure |
Extension Phase Sub Study
n=984 Participants
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
360 Day S-ICD Complication Free Rate
|
970 Participants
|
PRIMARY outcome
Timeframe: From enrollment to 5-year annual visit.Population: All implanted patients (N=984)
The number of subjects who received at least one inappropriate shock for SVT above the discrimination zone and SVT discriminator errors divided by the total implanted subjects.
Outcome measures
| Measure |
Extension Phase Sub Study
n=984 Participants
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Percentage of Inappropriate Shocks for Atrial Fibrillation (AF)/Supraventricular Tachycardia (SVT)
|
29 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
Rate of adverse events related to the S-ICD system in subjects of the EFFORTLESS Extension Phase sub study
Outcome measures
| Measure |
Extension Phase Sub Study
n=203 Participants
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Rate of Long-term S-ICD System-related Adverse Events
240 Days Post Replacement Procedure
|
95.0 Percentage of Survival w/o l-term AE
Interval 92.1 to 98.0
|
|
Extension Phase Rate of Long-term S-ICD System-related Adverse Events
360 Days Post Replacement Procedure
|
94.6 Percentage of Survival w/o l-term AE
Interval 91.4 to 97.7
|
|
Extension Phase Rate of Long-term S-ICD System-related Adverse Events
720 Days Post Replacement Procedure
|
93.6 Percentage of Survival w/o l-term AE
Interval 90.2 to 96.9
|
|
Extension Phase Rate of Long-term S-ICD System-related Adverse Events
1080 Days Post Replacement Procedure
|
92.6 Percentage of Survival w/o l-term AE
Interval 88.9 to 96.2
|
|
Extension Phase Rate of Long-term S-ICD System-related Adverse Events
1440 Days Post Replacement Procedure
|
92.0 Percentage of Survival w/o l-term AE
Interval 88.3 to 95.8
|
|
Extension Phase Rate of Long-term S-ICD System-related Adverse Events
1800 Days Post Replacement Procedure
|
90.5 Percentage of Survival w/o l-term AE
Interval 86.2 to 94.8
|
|
Extension Phase Rate of Long-term S-ICD System-related Adverse Events
2160 Days Post Replacement Procedure
|
89.3 Percentage of Survival w/o l-term AE
Interval 84.6 to 94.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment into the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
Number of S-ICD replacements with another type of implantable defibrillator for functionality unavailable with an S-ICD, such as a need for additional brady therapy, cardiac resynchronization therapy, antitachycardia pacing, or other similar reasons
Outcome measures
| Measure |
Extension Phase Sub Study
n=26 S-ICD replacements for functionality
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase S-ICD Replacements for Functionality
Battery: Early Battery Depletion
|
12 Subjects w. repl. for functionality
|
|
Extension Phase S-ICD Replacements for Functionality
Inappropriate Shocks
|
5 Subjects w. repl. for functionality
|
|
Extension Phase S-ICD Replacements for Functionality
Change in Indication: Need Bi-V Pacing
|
3 Subjects w. repl. for functionality
|
|
Extension Phase S-ICD Replacements for Functionality
Change in Indication: Need Additional ICD Programmability for VT
|
1 Subjects w. repl. for functionality
|
|
Extension Phase S-ICD Replacements for Functionality
Change in Indication: Need Bradycardia Pacing
|
1 Subjects w. repl. for functionality
|
|
Extension Phase S-ICD Replacements for Functionality
Investigator Discretion
|
1 Subjects w. repl. for functionality
|
|
Extension Phase S-ICD Replacements for Functionality
MRI Compatibility
|
1 Subjects w. repl. for functionality
|
|
Extension Phase S-ICD Replacements for Functionality
S-ICD PG Suspected Malfunction
|
1 Subjects w. repl. for functionality
|
|
Extension Phase S-ICD Replacements for Functionality
Unknown reason for out of service
|
1 Subjects w. repl. for functionality
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
Minimum Implant Time (Days). The data includes information on devices tracked from the date of implant until they went out of service, as well as devices tracked from implant until the last available follow-up before the subject exited the study for any reason (such as study conclusion, death, or withdrawal). Devices still functioning at the end of their observation period continue to add to their longevity beyond this period. Thus, the reported value underestimates actual device longevity, representing only the minimum duration these devices were known to function.
Outcome measures
| Measure |
Extension Phase Sub Study
n=418 pulse generators
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Device Longevity
PG Model 1010
|
2063.7 Minimum Implant time [days]
Standard Deviation 494.1
|
|
Extension Phase Device Longevity
PG Model A209
|
1539.1 Minimum Implant time [days]
Standard Deviation 676.6
|
|
Extension Phase Device Longevity
PG Model A219
|
1485.5 Minimum Implant time [days]
Standard Deviation 630.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
K-M Estimate (%) for freedom of complications related to the S-ICD replacements
Outcome measures
| Measure |
Extension Phase Sub Study
n=203 Participants
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Rate of Complications Related to the S-ICD Replacements
240 Days Post Replacement Procedure
|
92.1 percentage of freedom from complications
Interval 88.4 to 95.8
|
|
Extension Phase Rate of Complications Related to the S-ICD Replacements
360 Days Post Replacement Procedure
|
91.1 percentage of freedom from complications
Interval 87.2 to 95.0
|
|
Extension Phase Rate of Complications Related to the S-ICD Replacements
720 Days Post Replacement Procedure
|
87.1 percentage of freedom from complications
Interval 82.5 to 91.7
|
|
Extension Phase Rate of Complications Related to the S-ICD Replacements
1080 Days Post Replacement Procedure
|
83.6 percentage of freedom from complications
Interval 78.5 to 88.7
|
|
Extension Phase Rate of Complications Related to the S-ICD Replacements
1440 Days Post Replacement Procedure
|
79.6 percentage of freedom from complications
Interval 74.0 to 85.2
|
|
Extension Phase Rate of Complications Related to the S-ICD Replacements
1800 Days Post Replacement Procedure
|
77.0 percentage of freedom from complications
Interval 70.9 to 83.1
|
|
Extension Phase Rate of Complications Related to the S-ICD Replacements
2160 Days Post Replacement Procedure
|
77.0 percentage of freedom from complications
Interval 70.6 to 83.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
K-M Estimate (%) for Freedom of appropriate shock therapy for VT/VF
Outcome measures
| Measure |
Extension Phase Sub Study
n=203 Participants
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Appropriate Shock Therapy for VT/VF
240 Days Post Implant
|
98.5 percentage of freedom of appr. shocks
Interval 96.8 to 100.0
|
|
Extension Phase Appropriate Shock Therapy for VT/VF
360 Days Post Implant
|
98.0 percentage of freedom of appr. shocks
Interval 96.1 to 99.9
|
|
Extension Phase Appropriate Shock Therapy for VT/VF
720 Days Post Implant
|
96.0 percentage of freedom of appr. shocks
Interval 93.3 to 98.7
|
|
Extension Phase Appropriate Shock Therapy for VT/VF
1080 Days Post Implant
|
94.0 percentage of freedom of appr. shocks
Interval 90.6 to 97.3
|
|
Extension Phase Appropriate Shock Therapy for VT/VF
1440 Days Post Implant
|
91.4 percentage of freedom of appr. shocks
Interval 87.2 to 95.5
|
|
Extension Phase Appropriate Shock Therapy for VT/VF
1800 Days Post Implant
|
85.4 percentage of freedom of appr. shocks
Interval 79.9 to 90.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
K-M Estimate (%) for Freedom of Inappropriate Shock Therapy
Outcome measures
| Measure |
Extension Phase Sub Study
n=203 Participants
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Inappropriate Shock Therapy
240 Days Post Implant
|
98.0 % of freedom of inappropriate shocks
Interval 96.1 to 99.9
|
|
Extension Phase Inappropriate Shock Therapy
360 Days Post Implant
|
96.0 % of freedom of inappropriate shocks
Interval 93.3 to 98.7
|
|
Extension Phase Inappropriate Shock Therapy
720 Days Post Implant
|
93.5 % of freedom of inappropriate shocks
Interval 90.1 to 96.9
|
|
Extension Phase Inappropriate Shock Therapy
1080 Days Post Implant
|
90.0 % of freedom of inappropriate shocks
Interval 85.9 to 94.2
|
|
Extension Phase Inappropriate Shock Therapy
1440 Days Post Implant
|
89.0 % of freedom of inappropriate shocks
Interval 84.6 to 93.4
|
|
Extension Phase Inappropriate Shock Therapy
1800 Days Post Implant
|
88.0 % of freedom of inappropriate shocks
Interval 83.2 to 92.7
|
|
Extension Phase Inappropriate Shock Therapy
2160 Days Post Implant
|
86.2 % of freedom of inappropriate shocks
Interval 80.9 to 91.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: Subjects participating in the Extension Phase for whom which VF induction testing was performed during the replacement procedures (N=33)
Percentage of VF induction testing at replacement
Outcome measures
| Measure |
Extension Phase Sub Study
n=33 Participants
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase VF Induction Testing at Replacement
Subjects with at least one evaluable conversion test · At least one Successful Conversion <= 65J
|
27 Participants
|
|
Extension Phase VF Induction Testing at Replacement
Subjects with at least one evaluable conversion test · Successful Conversions > 65J only
|
1 Participants
|
|
Extension Phase VF Induction Testing at Replacement
Subjects with at least one evaluable conversion test · Subjects with Successful Shock Energy NOT Documented
|
1 Participants
|
|
Extension Phase VF Induction Testing at Replacement
Subjects with at least one evaluable conversion test · All Conversions have Incomplete Data
|
0 Participants
|
|
Extension Phase VF Induction Testing at Replacement
Subjects with only non-evaluable conversion tests · At least one Successful Conversion <= 65J
|
0 Participants
|
|
Extension Phase VF Induction Testing at Replacement
Subjects with only non-evaluable conversion tests · Successful Conversions > 65J only
|
0 Participants
|
|
Extension Phase VF Induction Testing at Replacement
Subjects with only non-evaluable conversion tests · Subjects with Successful Shock Energy NOT Documented
|
0 Participants
|
|
Extension Phase VF Induction Testing at Replacement
Subjects with only non-evaluable conversion tests · All Conversions have Incomplete Data
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Number of Additional invasive interventions
Outcome measures
| Measure |
Extension Phase Sub Study
n=203 Participants
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Additional Invasive Interventions
PG Revision
|
13 Number of Interventions
|
|
Extension Phase Additional Invasive Interventions
Electrode Revision
|
5 Number of Interventions
|
|
Extension Phase Additional Invasive Interventions
Major Cardiac Surgery Revision
|
5 Number of Interventions
|
|
Extension Phase Additional Invasive Interventions
Other, incl. blood draw, IV Rx, angio, cardioversion, PCI, ablation
|
64 Number of Interventions
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
Number of subjects with additional invasive interventions
Outcome measures
| Measure |
Extension Phase Sub Study
n=203 Participants
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Additional Invasive Interventions
PG Revision
|
13 participants w. add. inv. intervention
|
|
Extension Phase Additional Invasive Interventions
Electrode Revision
|
5 participants w. add. inv. intervention
|
|
Extension Phase Additional Invasive Interventions
Major Cardiac Surgery Revision
|
5 participants w. add. inv. intervention
|
|
Extension Phase Additional Invasive Interventions
Other, incl. blood draw, IV Rx, angio, cardioversion, PCI, ablation
|
36 participants w. add. inv. intervention
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
Number of subjects in the Extension Phase using anti-arrhythmic drugs
Outcome measures
| Measure |
Extension Phase Sub Study
n=203 Participants
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class I - Sodium Channel Blockers: Disopyramide
|
2 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class I - Sodium Channel Blockers: Flecainide
|
2 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class I - Sodium Channel Blockers: Mexiletine
|
2 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class I - Sodium Channel Blockers: Quinidine
|
1 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class II - Beta Blockers: Atenolol
|
5 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class II - Beta Blockers: Bisoprolol
|
79 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class II - Beta Blockers: Carvedilol
|
12 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class II - Beta Blockers: Celiprolol
|
1 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class II - Beta Blockers: Metoprolol
|
34 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class II - Beta Blockers: Nadolol
|
1 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class II - Beta Blockers: Nebivolol
|
7 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class II - Beta Blockers: Propranolol
|
2 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class III - Potassium Channel Blockers: Amiodarone
|
24 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class III - Potassium Channel Blockers: Sotalol
|
8 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class IV - Calcium Channel Blockers: Amlodipine
|
5 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class IV - Calcium Channel Blockers: Diltiazem
|
3 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class IV - Calcium Channel Blockers: Felodipine
|
1 Participants
|
|
Extension Phase Use of Anti-arrhythmic Drugs
Class IV - Calcium Channel Blockers: Verapamil
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
Ventricular rate in of episodes in beats per minute
Outcome measures
| Measure |
Extension Phase Sub Study
n=60 episodes
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Ventricular Rate of Episodes (Mean)
Rate of observed discrete MVT Episodes
|
217.5 episodes
Standard Deviation 33.3
|
|
Extension Phase Ventricular Rate of Episodes (Mean)
Rate of observed discrete PVT/VF Episodes
|
269.6 episodes
Standard Deviation 51.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
Ventricular rate in of episodes in beats per minute
Outcome measures
| Measure |
Extension Phase Sub Study
n=60 episodes
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Ventricular Rate of Episodes (Median)
Rate of observed discrete MVT Episodes
|
210 beats per minute
Interval 120.0 to 320.0
|
|
Extension Phase Ventricular Rate of Episodes (Median)
Rate of observed discrete PVT/VF Episodes
|
260 beats per minute
Interval 200.0 to 400.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
Ventricular rate in of episodes in beats per minute
Outcome measures
| Measure |
Extension Phase Sub Study
n=60 episodes
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Ventricular Rate of Episodes (IQR)
Rate of observed discrete MVT Episodes
|
217.5 beats per minute
Interval 200.0 to 240.0
|
|
Extension Phase Ventricular Rate of Episodes (IQR)
Rate of observed discrete PVT/VF Episodes
|
269.6 beats per minute
Interval 240.0 to 300.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
Ventricular rate in of episodes in beats per minute
Outcome measures
| Measure |
Extension Phase Sub Study
n=83 episodes
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Ventricular Rate of Non-Sustained Episodes (Mean)
Rate of observed Non-Sustained MVT Episodes
|
212.3 beats per minute
Standard Deviation 25.8
|
|
Extension Phase Ventricular Rate of Non-Sustained Episodes (Mean)
Rate of observed Non-Sustained PVT/VF Episodes
|
248.4 beats per minute
Standard Deviation 60.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
Ventricular rate in of episodes in beats per minute
Outcome measures
| Measure |
Extension Phase Sub Study
n=83 episodes
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Ventricular Rate of Non-Sustained Episodes (Median)
Rate of observed Non-Sustained MVT Episodes
|
200 beats per minute
Interval 180.0 to 300.0
|
|
Extension Phase Ventricular Rate of Non-Sustained Episodes (Median)
Rate of observed Non-Sustained PVT/VF Episodes
|
245 beats per minute
Interval 184.0 to 400.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
Ventricular rate in of episodes in beats per minute
Outcome measures
| Measure |
Extension Phase Sub Study
n=83 episodes
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Extension Phase Ventricular Rate of Non-Sustained Episodes (IQR)
Rate of observed Non-Sustained MVT Episodes
|
212.3 beats per minute
Interval 200.0 to 220.0
|
|
Extension Phase Ventricular Rate of Non-Sustained Episodes (IQR)
Rate of observed Non-Sustained PVT/VF Episodes
|
248.4 beats per minute
Interval 210.0 to 260.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment in the initial main study until the 5th annual follow-up of the substudy.Population: All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)
Summary of all reported complications defined as a clinical event that results in invasive intervention.
Outcome measures
| Measure |
Extension Phase Sub Study
n=105 events
Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry
|
|---|---|
|
Complication Events
Abnormal Thyroid Condition
|
1 events
|
|
Complication Events
Adverse Reaction (Medications) (Non-System/Non-Procedure related)
|
1 events
|
|
Complication Events
Adverse Reaction (Respiratory)
|
1 events
|
|
Complication Events
Anemia
|
1 events
|
|
Complication Events
Atrial Fibrillation/Flutter (Cardiac)
|
6 events
|
|
Complication Events
Cancer
|
3 events
|
|
Complication Events
Cardiac Arrest
|
4 events
|
|
Complication Events
Chest Pain (Cardiac)
|
1 events
|
|
Complication Events
Coronary Artery Disease
|
6 events
|
|
Complication Events
Death (as stand-alone event)
|
2 events
|
|
Complication Events
Electrode Movement
|
1 events
|
|
Complication Events
Erosion
|
2 events
|
|
Complication Events
Fracture/Broken Bone
|
2 events
|
|
Complication Events
GI Disorder
|
2 events
|
|
Complication Events
HEENT Disorder
|
1 events
|
|
Complication Events
Heart Failure/Worsening of Heart Failure
|
17 events
|
|
Complication Events
Hematoma not related to TV-ICD Placement
|
2 events
|
|
Complication Events
Hematoma related to TV-ICD Placement
|
1 events
|
|
Complication Events
Inappropriate Shock: Cardiac Oversensing
|
3 events
|
|
Complication Events
Inappropriate Shock: Non-Cardiac Oversensing
|
2 events
|
|
Complication Events
Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function)
|
1 events
|
|
Complication Events
Infection not related to S-ICD System
|
3 events
|
|
Complication Events
Inflammation (Non-Cardiac/Non-System/Non-Procedure related)
|
1 events
|
|
Complication Events
Multi-system Failure
|
2 events
|
|
Complication Events
Other (Non-Cardiac/Non-System/Non-Procedure related)
|
1 events
|
|
Complication Events
Other: Cardiac (Non-System/Procedure related)
|
1 events
|
|
Complication Events
Pain/Discomfort (Non-Cardiac/Non-System/Non-Procedure related)
|
2 events
|
|
Complication Events
Peripheral Vascular Disease
|
1 events
|
|
Complication Events
Pneumonia
|
4 events
|
|
Complication Events
Premature Cell Battery Depletion: Premature Declaration
|
5 events
|
|
Complication Events
Premature Cell Battery Depletion: Random Component Failure
|
2 events
|
|
Complication Events
Respiratory Failure (Non-Cardiac/Non-System/Non-Procedure related)
|
1 events
|
|
Complication Events
Shortness of Breath, Dyspnea (Non-Cardiac/Non-System/Non-Procedure related)
|
1 events
|
|
Complication Events
Skeletal/ Muscular Injury
|
1 events
|
|
Complication Events
Syncope (Non-Cardiac/Non-System/Non-Procedure related)
|
2 events
|
|
Complication Events
System Infection
|
1 events
|
|
Complication Events
Unable to Convert: During Procedure
|
1 events
|
|
Complication Events
Worsening of Benign Prostatic Hyperplasia
|
1 events
|
|
Complication Events
Worsening of VT/VF
|
15 events
|
Adverse Events
EFFORTLESS Main Study
Serious events: 199 serious events
Other events: 531 other events
Deaths: 91 deaths
Serious adverse events
| Measure |
EFFORTLESS Main Study
n=984 participants at risk
Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.
S-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool.
|
|---|---|
|
Product Issues
Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Inappropriate Shock: Cardiac Oversensing
|
1.0%
10/984 • Number of events 11 • From enrollment to 5-year annual visit.
|
|
Product Issues
Inappropriate Shock: Non-Cardiac Oversensing
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
PG Movement
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Product Issues
Erosion
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Product Issues
Inability to Communicate with the Device
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Psychiatric disorders
Fear of Shocks
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Imminent Erosion
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Suspected Device Malfunction
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Infections and infestations
Incision/Superficial Infection
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Infections and infestations
System Infection
|
0.91%
9/984 • Number of events 9 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Atrial Fibrillation/Flutter (Procedure related)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Hematoma
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Sub-optimal Electrode position
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Adverse Reaction (Medications)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Adverse Reaction (General)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Electrode Movement
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Bleeding (Procedure related)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Postoperative Limited Emphysema
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Atrial Fibrillation/Flutter (Cardiac)
|
0.71%
7/984 • Number of events 9 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Heart Failure/Worsening of Heart Failure
|
4.7%
46/984 • Number of events 53 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Myocardial Infarction
|
0.81%
8/984 • Number of events 8 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Cardiac Arrest
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Blood and lymphatic system disorders
Thrombosis
|
0.20%
2/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Syncope (Cardiac)
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Worsening of VT/VF
|
1.5%
15/984 • Number of events 18 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Coronary Artery Disease
|
1.0%
10/984 • Number of events 10 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Angina
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Chest Pain (Cardiac)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Vascular disorders
Peripheral Vascular Disease
|
0.61%
6/984 • Number of events 6 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Bradycardia/AV Block
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Right Bundle Branch Block
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.2%
12/984 • Number of events 13 • From enrollment to 5-year annual visit.
|
|
Vascular disorders
Stroke (Non-System/Non-Procedure related)
|
0.71%
7/984 • Number of events 7 • From enrollment to 5-year annual visit.
|
|
Infections and infestations
Infection not related to S-ICD System
|
1.6%
16/984 • Number of events 17 • From enrollment to 5-year annual visit.
|
|
Psychiatric disorders
Psychological Disorder
|
0.30%
3/984 • Number of events 4 • From enrollment to 5-year annual visit.
|
|
General disorders
Pain/Discomfort (Non-Cardiac/Non-System/Non-Procedure related)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Pneumothorax (Non-System/Non-Procedure related)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Gastrointestinal disorders
GI Disorder
|
0.51%
5/984 • Number of events 5 • From enrollment to 5-year annual visit.
|
|
Endocrine disorders
Abnormal Thyroid Condition
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Bleeding (Non-System/Non-Procedure related)
|
0.71%
7/984 • Number of events 7 • From enrollment to 5-year annual visit.
|
|
Product Issues
Implant/Replacement of Any Concomitant Device
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Fracture/Broken Bone
|
0.41%
4/984 • Number of events 4 • From enrollment to 5-year annual visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.1%
11/984 • Number of events 11 • From enrollment to 5-year annual visit.
|
|
Renal and urinary disorders
Kidney Disease
|
0.81%
8/984 • Number of events 9 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Trauma (Non-Cardiac/Non-System/Non-Procedure related)
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Respiratory, thoracic and mediastinal disorders
HEENT Disorder
|
0.30%
3/984 • Number of events 4 • From enrollment to 5-year annual visit.
|
|
General disorders
Death
|
0.71%
7/984 • Number of events 7 • From enrollment to 5-year annual visit.
|
|
General disorders
Neurological
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
General disorders
Other (Non-Cardiac/Non-System/Non-Procedure related)
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Metabolism and nutrition disorders
Metabolic Disorder
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
General disorders
Multi-system Failure
|
1.8%
18/984 • Number of events 18 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Other: Cardiac (Non-System/Procedure related)
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure (Non-Cardiac/Non-System/Non-Procedure related)
|
0.51%
5/984 • Number of events 5 • From enrollment to 5-year annual visit.
|
|
General disorders
Unable to Convert: During Procedure
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
Other adverse events
| Measure |
EFFORTLESS Main Study
n=984 participants at risk
Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.
S-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool.
|
|---|---|
|
Product Issues
Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function)
|
2.3%
23/984 • Number of events 35 • From enrollment to 5-year annual visit.
|
|
Product Issues
Inappr. Shock: Conv. bef. shock (Normal Function)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Inappropriate Shock: Cardiac Oversensing
|
10.7%
105/984 • Number of events 148 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Adverse Reaction (Bradycardia)
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Product Issues
Inappropriate Shock: Non-Cardiac Oversensing
|
2.5%
25/984 • Number of events 28 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Adverse Reaction (Medications)
|
0.41%
4/984 • Number of events 4 • From enrollment to 5-year annual visit.
|
|
Product Issues
Inappropriate Shock: Discrimination Error
|
0.61%
6/984 • Number of events 7 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Adverse Reaction (Respiratory)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Phantom Shock
|
1.0%
10/984 • Number of events 10 • From enrollment to 5-year annual visit.
|
|
Product Issues
Premature Cell Battery Depletion: Premature Declaration
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Atrial Fibrillation/Flutter (Procedure related)
|
0.51%
5/984 • Number of events 5 • From enrollment to 5-year annual visit.
|
|
Product Issues
Premature Cell Battery Depletion: Random Component Failure
|
0.51%
5/984 • Number of events 5 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Bleeding (Procedure related)
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Product Issues
PG Movement
|
0.81%
8/984 • Number of events 9 • From enrollment to 5-year annual visit.
|
|
Product Issues
Inability to Communicate with the Device
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Psychiatric disorders
Phantom Vibration
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Psychiatric disorders
Phantom Beeps
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Erosion
|
1.6%
16/984 • Number of events 16 • From enrollment to 5-year annual visit.
|
|
Product Issues
Discomfort
|
7.5%
74/984 • Number of events 87 • From enrollment to 5-year annual visit.
|
|
Product Issues
Imminent Erosion
|
0.41%
4/984 • Number of events 4 • From enrollment to 5-year annual visit.
|
|
Product Issues
Electrode Movement
|
0.81%
8/984 • Number of events 8 • From enrollment to 5-year annual visit.
|
|
Psychiatric disorders
Fear of Shocks
|
1.1%
11/984 • Number of events 12 • From enrollment to 5-year annual visit.
|
|
Product Issues
Electrode damaged and replaced during concomitant device procedure
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Suspected Device Malfunction
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Undersensing: Defibrillation
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Infections and infestations
Fever
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Fluid Accumulation (Procedure related)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Programmer/Software Error code
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Inappropriate Post Shock Pacing
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Hematoma
|
3.0%
30/984 • Number of events 34 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Inadequate Pocket Size
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Inadequate/Prolonged Healing of Incision Site
|
0.81%
8/984 • Number of events 8 • From enrollment to 5-year annual visit.
|
|
Infections and infestations
Incision/Superficial Infection
|
2.4%
24/984 • Number of events 24 • From enrollment to 5-year annual visit.
|
|
Skin and subcutaneous tissue disorders
Keloid
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Nerve Damage (Procedure related)
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Infections and infestations
System Infection
|
2.4%
24/984 • Number of events 26 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Sub-optimal Electrode position
|
0.71%
7/984 • Number of events 7 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Syncope (Procedure related)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Sub-optimal PG position
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Sub-optimal PG and Electrode position
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Redness/Irritation
|
1.3%
13/984 • Number of events 14 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.41%
4/984 • Number of events 4 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Subcutaneous Emphysema
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Suture Discomfort
|
0.61%
6/984 • Number of events 6 • From enrollment to 5-year annual visit.
|
|
Product Issues
Device Malfunction
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Other (Procedure related: PG)
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Product Issues
Other (Procedure related: Electrode)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Atrial Fibrillation/Flutter (Cardiac)
|
3.5%
34/984 • Number of events 74 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Heart Failure/Worsening of Heart Failure
|
4.9%
48/984 • Number of events 87 • From enrollment to 5-year annual visit.
|
|
Vascular disorders
Hypotension
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Myocardial Infarction
|
0.81%
8/984 • Number of events 8 • From enrollment to 5-year annual visit.
|
|
Blood and lymphatic system disorders
Thrombosis
|
0.61%
6/984 • Number of events 7 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Syncope (Cardiac)
|
2.2%
22/984 • Number of events 27 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Near Syncope/Dizziness/Shortness of Breath/Confusion (Cardiac)
|
1.9%
19/984 • Number of events 21 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
VT below Conditional Zone
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Worsening of VT/VF
|
7.0%
69/984 • Number of events 105 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Palpitations
|
3.5%
34/984 • Number of events 42 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.71%
7/984 • Number of events 8 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Chest Pain (Cardiac)
|
2.4%
24/984 • Number of events 28 • From enrollment to 5-year annual visit.
|
|
Vascular disorders
Peripheral Vascular Disease
|
0.61%
6/984 • Number of events 6 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Bradycardia/AV Block
|
1.4%
14/984 • Number of events 14 • From enrollment to 5-year annual visit.
|
|
Infections and infestations
Inflammation (Cardiac)
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Right Bundle Branch Block
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.81%
8/984 • Number of events 8 • From enrollment to 5-year annual visit.
|
|
Vascular disorders
Stroke (Non-System/Non-Procedure related)
|
0.51%
5/984 • Number of events 5 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Syncope (Non-Cardiac/Non-System/Non-Procedure related)
|
1.4%
14/984 • Number of events 15 • From enrollment to 5-year annual visit.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Infections and infestations
Infection not related to S-ICD System
|
2.4%
24/984 • Number of events 26 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Hematoma (Non-System/Non-Procedure related)
|
0.41%
4/984 • Number of events 4 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Hematoma (Post Explant of S-ICD System)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Near Syncope/Dizziness/Shortness of Breath/Confusion (Non-Cardiac/Non-System/Non-Procedure related)
|
1.8%
18/984 • Number of events 20 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Shortness of Breath, Dyspnea (Non-Cardiac/Non-System/Non-Procedure related)
|
1.3%
13/984 • Number of events 13 • From enrollment to 5-year annual visit.
|
|
Psychiatric disorders
Psychological Disorder
|
1.3%
13/984 • Number of events 13 • From enrollment to 5-year annual visit.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
General disorders
Pain/Discomfort (Non-Cardiac/Non-System/Non-Procedure related)
|
2.1%
21/984 • Number of events 27 • From enrollment to 5-year annual visit.
|
|
Gastrointestinal disorders
Acute Appendicitis
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Pleural Effusion (Non-System/Non-Procedure related)
|
0.10%
1/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Gastrointestinal disorders
GI Disorder
|
2.7%
27/984 • Number of events 37 • From enrollment to 5-year annual visit.
|
|
Endocrine disorders
Abnormal Thyroid Condition
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Blood and lymphatic system disorders
Anemia
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Bleeding (Non-System/Non-Procedure related)
|
0.81%
8/984 • Number of events 10 • From enrollment to 5-year annual visit.
|
|
General disorders
Nausea/Vomiting
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Product Issues
Repositioning of Any Concomitant Device
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Product Issues
Implant/Replacement of Any Concomitant Device
|
0.71%
7/984 • Number of events 8 • From enrollment to 5-year annual visit.
|
|
Infections and infestations
Inflammation (Non-Cardiac/Non-System/Non-Procedure related)
|
0.71%
7/984 • Number of events 7 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Fracture/Broken Bone
|
1.1%
11/984 • Number of events 12 • From enrollment to 5-year annual visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Renal and urinary disorders
Kidney Disease
|
1.2%
12/984 • Number of events 16 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Trauma (Non-Cardiac/Non-System/Non-Procedure related)
|
0.91%
9/984 • Number of events 11 • From enrollment to 5-year annual visit.
|
|
Respiratory, thoracic and mediastinal disorders
HEENT Disorder
|
1.4%
14/984 • Number of events 18 • From enrollment to 5-year annual visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
General disorders
Fluid Accumulation (Non-Cardiac/Non-System/Non-Procedure related)
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
General disorders
Flu
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
General disorders
Genital/Urinary
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
General disorders
Neurological
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
General disorders
Other (Non-Cardiac/Non-System/Non-Procedure related)
|
1.1%
11/984 • Number of events 11 • From enrollment to 5-year annual visit.
|
|
Metabolism and nutrition disorders
Metabolic Disorder
|
0.51%
5/984 • Number of events 6 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Abnormal Lab Values
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Mitral Insufficiency
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
Other: Cardiac (Non-System/Procedure related)
|
0.91%
9/984 • Number of events 9 • From enrollment to 5-year annual visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure (Non-Cardiac/Non-System/Non-Procedure related)
|
0.30%
3/984 • Number of events 5 • From enrollment to 5-year annual visit.
|
|
General disorders
Unable to Convert: During Procedure
|
0.91%
9/984 • Number of events 9 • From enrollment to 5-year annual visit.
|
|
General disorders
Adverse Reaction (Medications) (Non-System/Non-Procedure related)
|
0.20%
2/984 • Number of events 2 • From enrollment to 5-year annual visit.
|
|
Psychiatric disorders
Altered Mental Status
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
|
General disorders
Hypertension
|
0.30%
3/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Injury, poisoning and procedural complications
Muscle Stimulation (Non-System/Non-Procedure related)
|
0.20%
2/984 • Number of events 3 • From enrollment to 5-year annual visit.
|
|
Cardiac disorders
SVT
|
0.41%
4/984 • Number of events 4 • From enrollment to 5-year annual visit.
|
|
Product Issues
Unable to Convert: During Spontaneous Episode
|
0.10%
1/984 • Number of events 1 • From enrollment to 5-year annual visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Consultant (PI) acknowledges and agrees that (i) Consultant shall not publish any data, report, white papers or other materials arising out of the Services performed pursuant to this Agreement without the prior written consent of Boston Scientific, and (ii) any such publication shall not include Boston Scientific Confidential Information except prior written consent of Boston Scientific.
- Publication restrictions are in place
Restriction type: OTHER