Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Not Applicable
Completed
- Conditions
- Ventricular Tachyarrhythmias
- Interventions
- Device: Subcutaneous Implantable Defibrillator (S-ICD) System
- Registration Number
- NCT00853645
- Lead Sponsor
- Boston Scientific Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subcutaneous implantable cardioverter defibrillator (S-ICD) System Subcutaneous Implantable Defibrillator (S-ICD) System Single-arm with 6 patients implanted with an S-ICD System
- Primary Outcome Measures
Name Time Method Number of Participants With a Successful Induced Ventricular Fibrillation Conversion 30 days Sustained ventricular fibrillation induced by the investigator is successfully converted. A successful conversion was defined as two consecutive successful shocks out of four attempts with either standard polarity or with reverse polarity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Auckland City Hospital
🇳🇿Auckland, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Auckland City Hospital🇳🇿Auckland, New Zealand