Ventricular Tachyarrhythmias
Conditions
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.
Interventions
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System Single-arm with 6 patients implanted with an S-ICD System | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System |
|---|---|
| Age, Continuous | 60.24 Years STANDARD_DEVIATION 11.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment New Zealand | 6 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 4 / 6 |
| serious Total, serious adverse events | 1 / 6 |
Outcome results
Primary
Number of Participants With a Successful Induced Ventricular Fibrillation Conversion
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.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System | Number of Participants With a Successful Induced Ventricular Fibrillation Conversion | 6 Participants |