Clinical trial NCT01117792: Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
Official title: Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACC/AHA/NASPE Class 1, IIa or IIb Indications
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-05-05
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Conversion of Induced Ventricular Fibrillation
timeFrame: Testing done during the implant procedure
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
Study officials:
affiliation: Boston Scientific Corporation
name: Stephen O'Connor, PhD, Hon FRCP
role: STUDY_DIRECTOR
References:
citation: Theuns DA, Crozier IG, Barr CS, Hood MA, Cappato R, Knops RE, Maass AH, Boersma LV, Jordaens L. Longevity of the Subcutaneous Implantable Defibrillator: Long-Term Follow-Up of the European Regulatory Trial Cohort. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1159-63. doi: 10.1161/CIRCEP.115.002953. Epub 2015 Jul 6.