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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01064076




Registration number
NCT01064076
Ethics application status
Date submitted
4/02/2010
Date registered
4/02/2010
Date last updated
7/02/2017

Titles & IDs
Public title
S-ICD® System IDE Clinical Study
Scientific title
S-ICD® System Clinical Investigation
Secondary ID [1] 0 0
DN-03909
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tachycardia, Ventricular 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - S-ICD System

Experimental: S-ICD System - This is a single arm study


Treatment: Devices: S-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).

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
180 days
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Implant/Pre-Discharge

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Netherlands
State/province [15] 0 0
Nieuwegein
Country [16] 0 0
Netherlands
State/province [16] 0 0
Rotterdam
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland
Country [18] 0 0
New Zealand
State/province [18] 0 0
Christchurch
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous
implantable defibrillator (S-ICD) System.
Trial website
https://clinicaltrials.gov/show/NCT01064076
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Husby, M.S., MPH
Address 0 0
Cameron Health, Inc. a Subsidiary of Boston Scientific
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications