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S-ICD® System Post Approval Study
trial testing S-ICD System in Primary Prevention of Sudden Cardiac Arrest in 1,766 participants. Completed in 15 October 2021.
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,766 |
| Start date | 12 March 2013 |
| Primary completion | 15 October 2021 |
| Estimated completion | 15 October 2021 |
| Sites | 87 locations across United States |
Boston Scientific Corporation — full company profile →
Eligibility, any sex, with Primary Prevention of Sudden Cardiac Arrest or Secondary Prevention of Sudden Cardiac Arrest. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| S-ICD System Implant Attempt | 1869 |
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.
| Group | Value | 95% CI |
|---|---|---|
| S-ICD System Implant Attempt | 505 |
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 attributab
| Group | Value | 95% CI |
|---|---|---|
| S-ICD System Implant Attempt | 1953 |
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 proced
| Group | Value | 95% CI |
|---|---|---|
| S-ICD System Implant Attempt | 2071 |
Time frame: Data was collected over a 60 month (5-year) follow-up period. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | S-ICD System Implant Attempt |
|---|---|---|
| Heart Failure (HF)/ Worsening HF | Cardiac disorders | — |
| Inappropriate Shock - Inappropriate Sensing: Cardiac Oversensing | Product Issues | — |
| Multisystem Failure - Other | General disorders | — |
| Worsening VT/VF | Cardiac disorders | — |
| Infection - Non-device/procedure related | Infections and infestations | — |
| Infection - S-ICD System/Implant Procedure related | Injury, poisoning and procedural complications | — |
| Death - unknown cause | General disorders | — |
| Myocardial Infarction | Vascular disorders | — |
| Chest Pain - Cardiovascular related | Cardiac disorders | — |
| Cardiac Arrest | Cardiac disorders | — |
| Stroke | Vascular disorders | — |
| Atrial Fibrillation / Atrial Flutter | Cardiac disorders | — |
| Bradycardia/ AV Block | Cardiac disorders | — |
| Pulseless Electrical Activity (PEA) | Cardiac disorders | — |
| Cardiogenic Shock | Cardiac disorders | — |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Hematoma <= 30 days post-implant - Procedure related | Injury, poisoning and procedural complications | — |
| Inappropriate Shock - Inappropriate Sensing: Extra-cardiac Oversensing | Product Issues | — |
| Kidney Disease | Renal and urinary disorders | — |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — |
| Syncope - Cardiovascular | Cardiac disorders | — |
| Inappropriate Shock - Above Programmed Rate Zone | Product Issues | — |
| Premature Cell Battery Depletion | Product Issues | — |
| Infection - Incisional/Superficial Infection - Procedure related | Injury, poisoning and procedural complications | — |
| Discomfort - Post-op ≤ 30-Days - Procedure related | Injury, poisoning and procedural complications | — |
| Reaction | System | S-ICD System Implant Attempt |
|---|---|---|
| Inappropriate Shock - Inappropriate Sensing: Cardiac Oversensing | Product Issues | — |
| Inappropriate Shock - Inappropriate Sensing: Extra-cardiac Oversensing | Product Issues | — |
| Discomfort - Post-op > 30-Days - Device related | Product Issues | — |
| Incisional/Superficial Infection - Procedure related | Injury, poisoning and procedural complications | — |
| Discomfort - Post-op ≤ 30-Days - Procedure related | Injury, poisoning and procedural complications | — |
| Hematoma <= 30 days post-implant - Procedure related | Injury, poisoning and procedural complications | — |
Most-reported serious reactions: Heart Failure (HF)/ Worsening HF, Inappropriate Shock - Inappropriate Sensing: Cardiac Oversensing, Multisystem Failure - Other, Worsening VT/VF, Infection - Non-device/procedure related, Infection - S-ICD System/Implant Procedure related, Death - unknown cause, Myocardial Infarction.
Data from ClinicalTrials.gov NCT01736618 adverse events section.
The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01736618.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing