Tachycardia, Ventricular
Conditions
Keywords
ICD, defibrillator
Brief summary
The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System. In addition, analysis of resource utilization and costs will be performed to document treatment costs for periods defined by Registry endpoints. Protocol 90904928 restricts enrolment to patients over 18 years of age while protocol 90904925 allows all patients to be included.
Detailed description
EFFORTLESS is an observational, post market, standard of care, Registry to be conducted at approximately 50 centers worldwide in patients requiring an ICD for the treatment of ventricular tachyarrhythmias. Patients included in the registry will have been implanted with the S-ICD system since its CE mark (commercial regulatory approval) and will be followed for up to 60 months. The patients' perception of their therapy will be evaluated using Quality of Life assessments and the Registry will include an exploratory analysis of resource utilization and costs based on measures of clinical outcome such as complication rates, unscheduled hospitalizations and length of stay. The objective will be to enable comparison of costs of the S-ICD system versus a standard transvenous system. An Extension Phase Sub-Study will extend the EFFORTLESS S-ICD Registry in order to achieve an average of approximately 8 years of follow-up from index procedure. A subgroup of approximately 200 patients will be enrolled at a sub-set of EFFORTLESS sites. The data analysis will focus on long-term S-ICD system-related adverse events, S-ICD replacements and device longevity.
Interventions
DEVICES-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.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main study: Inclusion Criteria 1. Age \>/= 18yrs 2. Eligible for implantation of an S-ICD system per local clinical guidelines or currently implanted with an S-ICD system (Software (SW) version 1.59.0 or later) 3. Willing and able to provide written informed consent or have informed consent as provided by a legal representative
Exclusion criteria
1. Participation in any other investigational study that may interfere with interpretation of the Registry results 2. Incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing 3. Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing Extension Phase Sub-study: Inclusion Criteria 1. Subjects who are actively enrolled in the EFFORTLESS S-ICD Registry OR Subjects who completed the 5-year follow-up in the EFFORTLESS S-ICD Registry. All clinical events, spontaneous and induced episode data and system replacement or revision data since the last EFFORTLESS S-ICD Annual Follow-Up of the main study must be available in medical files or equivalent. 2. Subjects who are actively implanted with an S-ICD pulse generator (SQ-RX, EMBLEM or EMBLEM MRI) and an S-ICD electrode (Q-TRAK or EMBLEM) or any other future commercial available versions 3. Willing and able to provide written informed consent or have informed consent as provided by a legal representative and willing to participate in all testing and follow-ups as described the Sub-Study protocol 4. Age 18 or above, and of legal age to give informed consent specific to national laws
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative S-ICD Complication Free Rate | 30 days post implant | The number of subjects without Type I Complications within 30 Days of Implant divided by the Total Implanted Subjects. |
| 360 Day S-ICD Complication Free Rate | Minimum 360 days post implant | The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications. |
| Percentage of Inappropriate Shocks for Atrial Fibrillation (AF)/Supraventricular Tachycardia (SVT) | From enrollment to 5-year annual visit. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Extension Phase Rate of Complications Related to the S-ICD Replacements | 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. | K-M Estimate (%) for freedom of complications related to the S-ICD replacements |
| Extension Phase Appropriate Shock Therapy for VT/VF | 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. | K-M Estimate (%) for Freedom of appropriate shock therapy for VT/VF |
| Extension Phase Inappropriate Shock Therapy | 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. | K-M Estimate (%) for Freedom of Inappropriate Shock Therapy |
| Extension Phase VF Induction Testing at Replacement | 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. | Percentage of VF induction testing at replacement |
| Extension Phase Additional Invasive Interventions | 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 |
| Extension Phase Use of Anti-arrhythmic Drugs | 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 subjects in the Extension Phase using anti-arrhythmic drugs |
| Extension Phase Rate of Long-term S-ICD System-related Adverse Events | 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. | Rate of adverse events related to the S-ICD system in subjects of the EFFORTLESS Extension Phase sub study |
| Extension Phase Ventricular Rate of Episodes (Median) | 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. | Ventricular rate in of episodes in beats per minute |
| Extension Phase Ventricular Rate of Episodes (IQR) | 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. | Ventricular rate in of episodes in beats per minute |
| Extension Phase Ventricular Rate of Non-Sustained Episodes (Mean) | 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. | Ventricular rate in of episodes in beats per minute |
| Extension Phase Ventricular Rate of Non-Sustained Episodes (Median) | 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. | Ventricular rate in of episodes in beats per minute |
| Extension Phase Ventricular Rate of Non-Sustained Episodes (IQR) | 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. | Ventricular rate in of episodes in beats per minute |
| Complication Events | From enrollment in the initial main study until the 5th annual follow-up of the substudy. | Summary of all reported complications defined as a clinical event that results in invasive intervention. |
| Extension Phase Ventricular Rate of Episodes (Mean) | 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. | Ventricular rate in of episodes in beats per minute |
| Extension Phase S-ICD Replacements for Functionality | 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. | 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 |
| Extension Phase Device Longevity | 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. | 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. |
Countries
Czechia, Denmark, France, Germany, Italy, Netherlands, New Zealand, Portugal, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 984 |
| Total | 984 |
Baseline characteristics
| Characteristic | EFFORTLESS Main Study | — |
|---|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 16.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 275 Participants | — |
| Sex: Female, Male Male | 709 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 91 / 984 |
| other Total, other adverse events | 531 / 984 |
| serious Total, serious adverse events | 199 / 984 |
Outcome results
Primary
360 Day S-ICD Complication Free Rate
The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications.
Time frame: Minimum 360 days post implant
Population: All implanted patients (N=984)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EFFORTLESS Main Study | 360 Day S-ICD Complication Free Rate | 970 Participants |
Primary
Percentage of Inappropriate Shocks for Atrial Fibrillation (AF)/Supraventricular Tachycardia (SVT)
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.
Time frame: From enrollment to 5-year annual visit.
Population: All implanted patients (N=984)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EFFORTLESS Main Study | Percentage of Inappropriate Shocks for Atrial Fibrillation (AF)/Supraventricular Tachycardia (SVT) | 29 Participants |
Primary
Perioperative S-ICD Complication Free Rate
The number of subjects without Type I Complications within 30 Days of Implant divided by the Total Implanted Subjects.
Time frame: 30 days post implant
Population: All implanted patients (N=984)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EFFORTLESS Main Study | Perioperative S-ICD Complication Free Rate | 983 Participants |
Other Pre-specified
Complication Events
Summary of all reported complications defined as a clinical event that results in invasive intervention.
Time frame: 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)
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| EFFORTLESS Main Study | Complication Events | Abnormal Thyroid Condition | 1 events |
| EFFORTLESS Main Study | Complication Events | Adverse Reaction (Medications) (Non-System/Non-Procedure related) | 1 events |
| EFFORTLESS Main Study | Complication Events | Adverse Reaction (Respiratory) | 1 events |
| EFFORTLESS Main Study | Complication Events | Anemia | 1 events |
| EFFORTLESS Main Study | Complication Events | Atrial Fibrillation/Flutter (Cardiac) | 6 events |
| EFFORTLESS Main Study | Complication Events | Cancer | 3 events |
| EFFORTLESS Main Study | Complication Events | Cardiac Arrest | 4 events |
| EFFORTLESS Main Study | Complication Events | Chest Pain (Cardiac) | 1 events |
| EFFORTLESS Main Study | Complication Events | Coronary Artery Disease | 6 events |
| EFFORTLESS Main Study | Complication Events | Death (as stand-alone event) | 2 events |
| EFFORTLESS Main Study | Complication Events | Electrode Movement | 1 events |
| EFFORTLESS Main Study | Complication Events | Erosion | 2 events |
| EFFORTLESS Main Study | Complication Events | Fracture/Broken Bone | 2 events |
| EFFORTLESS Main Study | Complication Events | GI Disorder | 2 events |
| EFFORTLESS Main Study | Complication Events | HEENT Disorder | 1 events |
| EFFORTLESS Main Study | Complication Events | Heart Failure/Worsening of Heart Failure | 17 events |
| EFFORTLESS Main Study | Complication Events | Hematoma not related to TV-ICD Placement | 2 events |
| EFFORTLESS Main Study | Complication Events | Hematoma related to TV-ICD Placement | 1 events |
| EFFORTLESS Main Study | Complication Events | Inappropriate Shock: Cardiac Oversensing | 3 events |
| EFFORTLESS Main Study | Complication Events | Inappropriate Shock: Non-Cardiac Oversensing | 2 events |
| EFFORTLESS Main Study | Complication Events | Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function) | 1 events |
| EFFORTLESS Main Study | Complication Events | Infection not related to S-ICD System | 3 events |
| EFFORTLESS Main Study | Complication Events | Inflammation (Non-Cardiac/Non-System/Non-Procedure related) | 1 events |
| EFFORTLESS Main Study | Complication Events | Multi-system Failure | 2 events |
| EFFORTLESS Main Study | Complication Events | Other (Non-Cardiac/Non-System/Non-Procedure related) | 1 events |
| EFFORTLESS Main Study | Complication Events | Other: Cardiac (Non-System/Procedure related) | 1 events |
| EFFORTLESS Main Study | Complication Events | Pain/Discomfort (Non-Cardiac/Non-System/Non-Procedure related) | 2 events |
| EFFORTLESS Main Study | Complication Events | Peripheral Vascular Disease | 1 events |
| EFFORTLESS Main Study | Complication Events | Pneumonia | 4 events |
| EFFORTLESS Main Study | Complication Events | Premature Cell Battery Depletion: Premature Declaration | 5 events |
| EFFORTLESS Main Study | Complication Events | Premature Cell Battery Depletion: Random Component Failure | 2 events |
| EFFORTLESS Main Study | Complication Events | Respiratory Failure (Non-Cardiac/Non-System/Non-Procedure related) | 1 events |
| EFFORTLESS Main Study | Complication Events | Shortness of Breath, Dyspnea (Non-Cardiac/Non-System/Non-Procedure related) | 1 events |
| EFFORTLESS Main Study | Complication Events | Skeletal/ Muscular Injury | 1 events |
| EFFORTLESS Main Study | Complication Events | Syncope (Non-Cardiac/Non-System/Non-Procedure related) | 2 events |
| EFFORTLESS Main Study | Complication Events | System Infection | 1 events |
| EFFORTLESS Main Study | Complication Events | Unable to Convert: During Procedure | 1 events |
| EFFORTLESS Main Study | Complication Events | Worsening of Benign Prostatic Hyperplasia | 1 events |
| EFFORTLESS Main Study | Complication Events | Worsening of VT/VF | 15 events |
Other Pre-specified
Extension Phase Additional Invasive Interventions
Number of Additional invasive interventions
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase Additional Invasive Interventions | PG Revision | 13 Number of Interventions |
| EFFORTLESS Main Study | Extension Phase Additional Invasive Interventions | Electrode Revision | 5 Number of Interventions |
| EFFORTLESS Main Study | Extension Phase Additional Invasive Interventions | Major Cardiac Surgery Revision | 5 Number of Interventions |
| EFFORTLESS Main Study | Extension Phase Additional Invasive Interventions | Other, incl. blood draw, IV Rx, angio, cardioversion, PCI, ablation | 64 Number of Interventions |
Other Pre-specified
Extension Phase Additional Invasive Interventions
Number of subjects with additional invasive interventions
Time frame: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase Additional Invasive Interventions | PG Revision | 13 participants w. add. inv. intervention |
| EFFORTLESS Main Study | Extension Phase Additional Invasive Interventions | Electrode Revision | 5 participants w. add. inv. intervention |
| EFFORTLESS Main Study | Extension Phase Additional Invasive Interventions | Major Cardiac Surgery Revision | 5 participants w. add. inv. intervention |
| EFFORTLESS Main Study | Extension Phase Additional Invasive Interventions | Other, incl. blood draw, IV Rx, angio, cardioversion, PCI, ablation | 36 participants w. add. inv. intervention |
Other Pre-specified
Extension Phase Appropriate Shock Therapy for VT/VF
K-M Estimate (%) for Freedom of appropriate shock therapy for VT/VF
Time frame: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase Appropriate Shock Therapy for VT/VF | 240 Days Post Implant | 98.5 percentage of freedom of appr. shocks |
| EFFORTLESS Main Study | Extension Phase Appropriate Shock Therapy for VT/VF | 360 Days Post Implant | 98.0 percentage of freedom of appr. shocks |
| EFFORTLESS Main Study | Extension Phase Appropriate Shock Therapy for VT/VF | 720 Days Post Implant | 96.0 percentage of freedom of appr. shocks |
| EFFORTLESS Main Study | Extension Phase Appropriate Shock Therapy for VT/VF | 1080 Days Post Implant | 94.0 percentage of freedom of appr. shocks |
| EFFORTLESS Main Study | Extension Phase Appropriate Shock Therapy for VT/VF | 1440 Days Post Implant | 91.4 percentage of freedom of appr. shocks |
| EFFORTLESS Main Study | Extension Phase Appropriate Shock Therapy for VT/VF | 1800 Days Post Implant | 85.4 percentage of freedom of appr. shocks |
Other Pre-specified
Extension Phase Device Longevity
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase Device Longevity | PG Model 1010 | 2063.7 Minimum Implant time [days] | Standard Deviation 494.1 |
| EFFORTLESS Main Study | Extension Phase Device Longevity | PG Model A209 | 1539.1 Minimum Implant time [days] | Standard Deviation 676.6 |
| EFFORTLESS Main Study | Extension Phase Device Longevity | PG Model A219 | 1485.5 Minimum Implant time [days] | Standard Deviation 630.3 |
Other Pre-specified
Extension Phase Inappropriate Shock Therapy
K-M Estimate (%) for Freedom of Inappropriate Shock Therapy
Time frame: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase Inappropriate Shock Therapy | 240 Days Post Implant | 98.0 % of freedom of inappropriate shocks |
| EFFORTLESS Main Study | Extension Phase Inappropriate Shock Therapy | 360 Days Post Implant | 96.0 % of freedom of inappropriate shocks |
| EFFORTLESS Main Study | Extension Phase Inappropriate Shock Therapy | 720 Days Post Implant | 93.5 % of freedom of inappropriate shocks |
| EFFORTLESS Main Study | Extension Phase Inappropriate Shock Therapy | 1080 Days Post Implant | 90.0 % of freedom of inappropriate shocks |
| EFFORTLESS Main Study | Extension Phase Inappropriate Shock Therapy | 1440 Days Post Implant | 89.0 % of freedom of inappropriate shocks |
| EFFORTLESS Main Study | Extension Phase Inappropriate Shock Therapy | 1800 Days Post Implant | 88.0 % of freedom of inappropriate shocks |
| EFFORTLESS Main Study | Extension Phase Inappropriate Shock Therapy | 2160 Days Post Implant | 86.2 % of freedom of inappropriate shocks |
Other Pre-specified
Extension Phase Rate of Complications Related to the S-ICD Replacements
K-M Estimate (%) for freedom of complications related to the S-ICD replacements
Time frame: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase Rate of Complications Related to the S-ICD Replacements | 240 Days Post Replacement Procedure | 92.1 percentage of freedom from complications |
| EFFORTLESS Main Study | Extension Phase Rate of Complications Related to the S-ICD Replacements | 360 Days Post Replacement Procedure | 91.1 percentage of freedom from complications |
| EFFORTLESS Main Study | Extension Phase Rate of Complications Related to the S-ICD Replacements | 720 Days Post Replacement Procedure | 87.1 percentage of freedom from complications |
| EFFORTLESS Main Study | Extension Phase Rate of Complications Related to the S-ICD Replacements | 1080 Days Post Replacement Procedure | 83.6 percentage of freedom from complications |
| EFFORTLESS Main Study | Extension Phase Rate of Complications Related to the S-ICD Replacements | 1440 Days Post Replacement Procedure | 79.6 percentage of freedom from complications |
| EFFORTLESS Main Study | Extension Phase Rate of Complications Related to the S-ICD Replacements | 1800 Days Post Replacement Procedure | 77.0 percentage of freedom from complications |
| EFFORTLESS Main Study | Extension Phase Rate of Complications Related to the S-ICD Replacements | 2160 Days Post Replacement Procedure | 77.0 percentage of freedom from complications |
Other Pre-specified
Extension Phase Rate of Long-term S-ICD System-related Adverse Events
Rate of adverse events related to the S-ICD system in subjects of the EFFORTLESS Extension Phase sub study
Time frame: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EFFORTLESS Main Study | 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 |
| EFFORTLESS Main Study | 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 |
| EFFORTLESS Main Study | 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 |
| EFFORTLESS Main Study | 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 |
| EFFORTLESS Main Study | 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 |
| EFFORTLESS Main Study | 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 |
| EFFORTLESS Main Study | 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 |
Other Pre-specified
Extension Phase S-ICD Replacements for Functionality
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
Time frame: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase S-ICD Replacements for Functionality | Battery: Early Battery Depletion | 12 Subjects w. repl. for functionality |
| EFFORTLESS Main Study | Extension Phase S-ICD Replacements for Functionality | Inappropriate Shocks | 5 Subjects w. repl. for functionality |
| EFFORTLESS Main Study | Extension Phase S-ICD Replacements for Functionality | Change in Indication: Need Bi-V Pacing | 3 Subjects w. repl. for functionality |
| EFFORTLESS Main Study | Extension Phase S-ICD Replacements for Functionality | Change in Indication: Need Additional ICD Programmability for VT | 1 Subjects w. repl. for functionality |
| EFFORTLESS Main Study | Extension Phase S-ICD Replacements for Functionality | Change in Indication: Need Bradycardia Pacing | 1 Subjects w. repl. for functionality |
| EFFORTLESS Main Study | Extension Phase S-ICD Replacements for Functionality | Investigator Discretion | 1 Subjects w. repl. for functionality |
| EFFORTLESS Main Study | Extension Phase S-ICD Replacements for Functionality | MRI Compatibility | 1 Subjects w. repl. for functionality |
| EFFORTLESS Main Study | Extension Phase S-ICD Replacements for Functionality | S-ICD PG Suspected Malfunction | 1 Subjects w. repl. for functionality |
| EFFORTLESS Main Study | Extension Phase S-ICD Replacements for Functionality | Unknown reason for out of service | 1 Subjects w. repl. for functionality |
Other Pre-specified
Extension Phase Use of Anti-arrhythmic Drugs
Number of subjects in the Extension Phase using anti-arrhythmic drugs
Time frame: 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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class I - Sodium Channel Blockers: Disopyramide | 2 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class I - Sodium Channel Blockers: Flecainide | 2 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class I - Sodium Channel Blockers: Mexiletine | 2 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class I - Sodium Channel Blockers: Quinidine | 1 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class II - Beta Blockers: Atenolol | 5 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class II - Beta Blockers: Bisoprolol | 79 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class II - Beta Blockers: Carvedilol | 12 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class II - Beta Blockers: Celiprolol | 1 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class II - Beta Blockers: Metoprolol | 34 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class II - Beta Blockers: Nadolol | 1 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class II - Beta Blockers: Nebivolol | 7 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class II - Beta Blockers: Propranolol | 2 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class III - Potassium Channel Blockers: Amiodarone | 24 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class III - Potassium Channel Blockers: Sotalol | 8 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class IV - Calcium Channel Blockers: Amlodipine | 5 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class IV - Calcium Channel Blockers: Diltiazem | 3 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class IV - Calcium Channel Blockers: Felodipine | 1 Participants |
| EFFORTLESS Main Study | Extension Phase Use of Anti-arrhythmic Drugs | Class IV - Calcium Channel Blockers: Verapamil | 8 Participants |
Other Pre-specified
Extension Phase Ventricular Rate of Episodes (IQR)
Ventricular rate in of episodes in beats per minute
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase Ventricular Rate of Episodes (IQR) | Rate of observed discrete MVT Episodes | 217.5 beats per minute |
| EFFORTLESS Main Study | Extension Phase Ventricular Rate of Episodes (IQR) | Rate of observed discrete PVT/VF Episodes | 269.6 beats per minute |
Other Pre-specified
Extension Phase Ventricular Rate of Episodes (Mean)
Ventricular rate in of episodes in beats per minute
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase Ventricular Rate of Episodes (Mean) | Rate of observed discrete MVT Episodes | 217.5 episodes | Standard Deviation 33.3 |
| EFFORTLESS Main Study | Extension Phase Ventricular Rate of Episodes (Mean) | Rate of observed discrete PVT/VF Episodes | 269.6 episodes | Standard Deviation 51.1 |
Other Pre-specified
Extension Phase Ventricular Rate of Episodes (Median)
Ventricular rate in of episodes in beats per minute
Time frame: 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)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase Ventricular Rate of Episodes (Median) | Rate of observed discrete MVT Episodes | 210 beats per minute |
| EFFORTLESS Main Study | Extension Phase Ventricular Rate of Episodes (Median) | Rate of observed discrete PVT/VF Episodes | 260 beats per minute |
Other Pre-specified
Extension Phase Ventricular Rate of Non-Sustained Episodes (IQR)
Ventricular rate in of episodes in beats per minute
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase Ventricular Rate of Non-Sustained Episodes (IQR) | Rate of observed Non-Sustained MVT Episodes | 212.3 beats per minute |
| EFFORTLESS Main Study | Extension Phase Ventricular Rate of Non-Sustained Episodes (IQR) | Rate of observed Non-Sustained PVT/VF Episodes | 248.4 beats per minute |
Other Pre-specified
Extension Phase Ventricular Rate of Non-Sustained Episodes (Mean)
Ventricular rate in of episodes in beats per minute
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EFFORTLESS Main Study | 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 |
| EFFORTLESS Main Study | 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 |
Other Pre-specified
Extension Phase Ventricular Rate of Non-Sustained Episodes (Median)
Ventricular rate in of episodes in beats per minute
Time frame: 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)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase Ventricular Rate of Non-Sustained Episodes (Median) | Rate of observed Non-Sustained MVT Episodes | 200 beats per minute |
| EFFORTLESS Main Study | Extension Phase Ventricular Rate of Non-Sustained Episodes (Median) | Rate of observed Non-Sustained PVT/VF Episodes | 245 beats per minute |
Other Pre-specified
Extension Phase VF Induction Testing at Replacement
Percentage of VF induction testing at replacement
Time frame: 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)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EFFORTLESS Main Study | Extension Phase VF Induction Testing at Replacement | Subjects with at least one evaluable conversion test | At least one Successful Conversion <= 65J | 27 Participants |
| EFFORTLESS Main Study | Extension Phase VF Induction Testing at Replacement | Subjects with at least one evaluable conversion test | Successful Conversions > 65J only | 1 Participants |
| EFFORTLESS Main Study | Extension Phase VF Induction Testing at Replacement | Subjects with at least one evaluable conversion test | Subjects with Successful Shock Energy NOT Documented | 1 Participants |
| EFFORTLESS Main Study | Extension Phase VF Induction Testing at Replacement | Subjects with at least one evaluable conversion test | All Conversions have Incomplete Data | 0 Participants |
| EFFORTLESS Main Study | Extension Phase VF Induction Testing at Replacement | Subjects with only non-evaluable conversion tests | At least one Successful Conversion <= 65J | 0 Participants |
| EFFORTLESS Main Study | Extension Phase VF Induction Testing at Replacement | Subjects with only non-evaluable conversion tests | Successful Conversions > 65J only | 0 Participants |
| EFFORTLESS Main Study | Extension Phase VF Induction Testing at Replacement | Subjects with only non-evaluable conversion tests | Subjects with Successful Shock Energy NOT Documented | 0 Participants |
| EFFORTLESS Main Study | Extension Phase VF Induction Testing at Replacement | Subjects with only non-evaluable conversion tests | All Conversions have Incomplete Data | 4 Participants |