The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01117792




Registration number
NCT01117792
Ethics application status
Date submitted
28/04/2010
Date registered
5/05/2010
Date last updated
16/02/2017

Titles & IDs
Public title
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
Scientific title
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
Secondary ID [1] 0 0
DN-01040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ACC/AHA/NASPE Class 1, IIa or IIb Indications 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - subcutaneous implantable defibrillator (S-ICD) system

Experimental: S-ICD System -


Treatment: Devices: subcutaneous implantable defibrillator (S-ICD) system
implantable defibrillator system

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

Outcomes
Primary outcome [1] 0 0
Conversion of induced ventricular fibrillation - Data was reported at 30 days and 6 months
Timepoint [1] 0 0
testing done during the implant procedure

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

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
Italy
State/province [1] 0 0
San Donato Milanese
Country [2] 0 0
Netherlands
State/province [2] 0 0
Amsterdam
Country [3] 0 0
Netherlands
State/province [3] 0 0
Groningen
Country [4] 0 0
Netherlands
State/province [4] 0 0
Nieuwegein
Country [5] 0 0
Netherlands
State/province [5] 0 0
Rotterdam
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
New Zealand
State/province [7] 0 0
Christchurch
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Dudley

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01117792
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen O'Connor, PhD, Hon FRCP
Address 0 0
Boston Scientific Corporation
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

Summary results
Other publications