N/A
N=6
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Ventricular Tachyarrhythmias
Bottom Line
View on ClinicalTrials.gov: NCT00853645 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With a Successful Induced Ventricular Fibrillation Conversion — 6 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
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Successful Induced Ventricular Fibrillation Conversion |
6 | — |
Summary
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.
Eligibility Criteria
Inclusion Criteria
- replacement of an existing transvenous implantable cardioverter defibrillator (ICD) system
- American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) Class I or II indications for ICD implantation
- Age >= 18 years
- Appropriate pre-operative Electrocardiogram (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 ventricular tachyarrhythmias (VT) that is reliably terminated with anti-tachycardia pacing
- Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
- Patients with chronic renal failure, i.e. with a creatinine level of >2.5 mg/dl unless prescribed drug therapy known to increase creatinine levels in which case the value should be <= 3mg/dl
Data sourced from ClinicalTrials.gov (NCT00853645). 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.