Clinical trial NCT00853645: Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Official title: Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachyarrhythmias
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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

Primary outcomes:
measure: Number of Participants With a Successful Induced Ventricular Fibrillation Conversion
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: Boston Scientific Corporation
name: Stephen O'Connor, PhD, Hon FRACP
role: STUDY_DIRECTOR
References:
citation: Bardy GH, Smith WM, Hood MA, Crozier IG, Melton IC, Jordaens L, Theuns D, Park RE, Wright DJ, Connelly DT, Fynn SP, Murgatroyd FD, Sperzel J, Neuzner J, Spitzer SG, Ardashev AV, Oduro A, Boersma L, Maass AH, Van Gelder IC, Wilde AA, van Dessel PF, Knops RE, Barr CS, Lupo P, Cappato R, Grace AA. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010 Jul 1;363(1):36-44. doi: 10.1056/NEJMoa0909545. Epub 2010 May 12.