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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01117792




Registration number
NCT01117792
Ethics application status
Date submitted
28/04/2010
Date registered
5/05/2010
Date last updated
2/07/2021

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
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
Sex
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
N/A
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
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2009
Sample size
Target
Accrual to date
Final
55
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01117792