N/A
N=55
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Bottom Line
View on ClinicalTrials.gov: NCT01117792 ↗Enrolled (actual)
55
Serious AEs
30.9%
Results posted
Jul 2021
Primary outcome: Primary: Conversion of Induced Ventricular Fibrillation — 52 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- subcutaneous implantable defibrillator (S-ICD) system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conversion of Induced Ventricular Fibrillation |
52 | — |
Summary
The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.
Eligibility Criteria
Inclusion Criteria
- Replacement of an existing implanted transvenous ICD system
- Class I, Class IIa, or Class IIb ACC/AHA/HRS indications for patients without an existing transvenous ICD system
- Age is >= 18 years
- Appropriate pre-operative ECG as measured with a specially developed template
Exclusion Criteria
- Subjects unable or unwilling to provide informed consent
- Any condition which precludes the subject's ability to comply with the study requirements
- 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 another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the 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
- Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
- Patients with impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with a GFR <= 29.
Data sourced from ClinicalTrials.gov (NCT01117792). 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.