Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation (NCT01117792) | Clinical Trial Compass
CompletedNot Applicable
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
Italy, Netherlands55 participantsStarted 2008-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Conversion of Induced Ventricular Fibrillation
Timeframe: Testing done during the implant procedure