Tachycardia, Ventricular
Conditions
Keywords
ICD, defibrillator
Brief summary
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
Detailed description
This clinical study is a prospective, non-randomized, multicenter clinical study without a control group conducted in the United States, Europe, and New Zealand. Patients meeting eligibility criteria for implanting an S-ICD System will be enrolled in this clinical study, implanted with an S-ICD System, and followed prior to hospital discharge, and post-implant at 30 days, 90 days, and 180 days. After the 180-day post-implant follow-up visit, patients will continue to be followed semi-annually until study closure. Eligible patients enrolled in this clinical study may also participate in the chronic conversion sub-study. The safety endpoint will be evaluated through the use of a 180-day S-ICD System complication-free rate. The effectiveness endpoint will be evaluated using an induced ventricular fibrillation (VF) conversion efficacy rate. Spontaneous episodes and chronic conversion testing data will be evaluated using descriptive statistics to provide additional data supporting the continued chronic performance of the S-ICD System.
Interventions
DEVICES-ICD System
The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the SQ-RX pulse generator (Model 1010), the Q-TRAK subcutaneous electrode (Model 3010), the Q-TECH programmer (Model 2020), and Q-GUIDE electrode insertion tools (Models 4010 and 4020).
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
* For patients without an existing transvenous device • Patient meets Class I, Class IIa or Class IIb indications/recommendations for ICD implantation per the current published guidelines at the time of enrollment * For patients with an existing transvenous device • Patient requires replacement or revision of an existing implanted transvenous ICD system * Age is ≥ 18 years * An appropriate pre-operative ECG per template provided
Exclusion criteria
* Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study. * 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 any other investigational study without prior written consent from the study 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, unless the patient is not a candidate for a transvenous ICD system. * Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant. * Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing. * Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated GFR ≤ 29.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Free of Type I Complications at 180 Days. | 180 days | Percentage of Participants Free of Type I Complications at 180 days compared to the performance goal of 79%. Type I complications are those caused by the S-ICD System. |
| Percentage of Participants Who Pass Induced VF Conversion Test | Implant/Pre-Discharge | Percentage of participants who pass induced VF conversion test was compared to a performance goal of 88%. Definition of a success was two consecutive successful 65 joule shocks out of four attempts in the same polarity. |
Countries
Netherlands, New Zealand, United Kingdom, United States
Participant flow
Recruitment details
A total of 33 investigational sites participated in the study, twenty-eight (28) of which were in the United States, 2 in New Zealand, 2 in The Netherlands and 1 in the United Kingdom. A total of 330 patients were enrolled between January 27, 2010 and May 20, 2011.
Pre-assignment details
Of the 330 enrollments, 321 underwent an implant procedure (implant attempt) and 9 were withdrawn prior to the commencement of the implant procedure.
Participants by arm
| Arm | Count |
|---|---|
| S-ICD System This is a single arm study | 321 |
| Total | 321 |
Baseline characteristics
| Characteristic | S-ICD System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 68 Participants |
| Age, Categorical Between 18 and 65 years | 253 Participants |
| Age, Continuous | 51.9 years STANDARD_DEVIATION 15.5 |
| Region of Enrollment Netherlands | 16 participants |
| Region of Enrollment New Zealand | 29 participants |
| Region of Enrollment United Kingdom | 1 participants |
| Region of Enrollment United States | 275 participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 238 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 104 / 321 |
| serious Total, serious adverse events | 52 / 321 |
Outcome results
Primary
Percentage of Participants Free of Type I Complications at 180 Days.
Percentage of Participants Free of Type I Complications at 180 days compared to the performance goal of 79%. Type I complications are those caused by the S-ICD System.
Time frame: 180 days
Population: The analysis cohort includes all subjects undergoing an implant attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Percentage of Participants Free of Type I Complications at 180 Days. | 99.0 percentage of participants |
Primary
Percentage of Participants Who Pass Induced VF Conversion Test
Percentage of participants who pass induced VF conversion test was compared to a performance goal of 88%. Definition of a success was two consecutive successful 65 joule shocks out of four attempts in the same polarity.
Time frame: Implant/Pre-Discharge
Population: 304 subjects had a complete VF conversion test recorded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Percentage of Participants Who Pass Induced VF Conversion Test | 96.5 percentage of participants |