N/A
N=1,766
S-ICD® System Post Approval Study
Primary Prevention of Sudden Cardiac Arrest · Secondary Prevention of Sudden Cardiac Arrest
Bottom Line
View on ClinicalTrials.gov: NCT01736618 ↗Enrolled (actual)
1,766
Serious AEs
36.1%
Results posted
Mar 2024
Primary outcome: Primary: Number of Participants Free From Type I Complication — 1869 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- S-ICD System (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Free From Type I Complication |
1869 | — |
| PRIMARY Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF |
505 | — |
| SECONDARY Number of Participants Free From Electrode-related Complications |
1953 | — |
| SECONDARY First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF |
2071 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD System in the S-ICD System Clinical Investigation (IDE G090013)
AND
- Willing and able to provide written informed consent or have informed consent provided by a legal representative
Exclusion Criteria
- Remaining life expectancy of less than 360 days
Data sourced from ClinicalTrials.gov (NCT01736618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.