ACC/AHA/NASPE Class 1, IIa or IIb Indications
Conditions
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.
Interventions
implantable defibrillator system
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion of Induced Ventricular Fibrillation | Testing done during the implant procedure | The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation. |
Countries
Italy, Netherlands, New Zealand, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| S-ICD System Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system. | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | S-ICD System |
|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 13.6 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 34 Participants |
| Race/Ethnicity, Customized European | 9 Participants |
| Race/Ethnicity, Customized Indian | 1 Participants |
| Race/Ethnicity, Customized Maori | 2 Participants |
| Race/Ethnicity, Customized New Zealander, European | 8 Participants |
| Region of Enrollment Italy | 5 participants |
| Region of Enrollment Netherlands | 21 participants |
| Region of Enrollment New Zealand | 21 participants |
| Region of Enrollment United Kingdom | 8 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 55 |
| other Total, other adverse events | 4 / 55 |
| serious Total, serious adverse events | 17 / 55 |
Outcome results
Primary
Conversion of Induced Ventricular Fibrillation
The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation.
Time frame: Testing done during the implant procedure
Population: Investigator induce sustained ventricular fibrillation conversion efficacy. Two of the 55 subjects implanted did not induce sustained ventricular fibrillation leaving 53 evaluable subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| S-ICD System | Conversion of Induced Ventricular Fibrillation | 52 Participants |