N/A
N=321
S-ICD® System IDE Clinical Study
Tachycardia, Ventricular
Bottom Line
View on ClinicalTrials.gov: NCT01064076 ↗Enrolled (actual)
321
Serious AEs
16.2%
Results posted
Mar 2017
Primary outcome: Primary: Percentage of Participants Free of Type I Complications at 180 Days. — 99.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- S-ICD System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Free of Type I Complications at 180 Days. |
99.0 | — |
| PRIMARY Percentage of Participants Who Pass Induced VF Conversion Test |
96.5 | — |
Summary
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
Eligibility Criteria
Inclusion Criteria
- For patients without an existing transvenous device
- Patient meets Class I, Class IIa or Class IIb indications/recommendations for ICD implantation per the current published guidelines at the time of enrollment
- For patients with an existing transvenous device
- Patient requires replacement or revision of an existing implanted transvenous ICD system
- Age is ≥ 18 years
- An appropriate pre-operative ECG per template provided
Exclusion Criteria
- Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study.
- Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study.
- Participation in any other investigational study without prior written consent from the study sponsor.
- Patients with a serious medical condition and life expectancy of less than one year.
- Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing, unless the patient is not a candidate for a transvenous ICD system.
- Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant.
- Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing.
- Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated GFR ≤ 29.
Data sourced from ClinicalTrials.gov (NCT01064076). 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.