Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Initial Chronic Human Validation Study: Subcutaneous Implantable (S-ICD) System (Chronic II)

This study has been completed.
Information provided by:
Boston Scientific Corporation Identifier:
First received: February 27, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 27, 2009
February 27, 2009
July 2008
September 2008   (final data collection date for primary outcome measure)
Induced VF conversion efficacy
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
Initial Chronic Human Validation Study: Subcutaneous Implantable (S-ICD) System
Initial Chronic Human Validation Study: Subcutaneous Implantable (S-ICD) System
Primary objective is to evaluate the safety and performance of the implanted 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.
Not Provided
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
ACC/AHA/HRS Class I and II Indications for ICD Implantation
Device: Subcutaneous Implantable Defibrillator (S-ICD) System
Not Provided
Bardy GH, Smith WM, Hood MA, Crozier IG, Melton IC, Jordaens L, Theuns D, Park RE, Wright DJ, Connelly DT, Fynn SP, Murgatroyd FD, Sperzel J, Neuzner J, Spitzer SG, Ardashev AV, Oduro A, Boersma L, Maass AH, Van Gelder IC, Wilde AA, van Dessel PF, Knops RE, Barr CS, Lupo P, Cappato R, Grace AA. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010 Jul 1;363(1):36-44. doi: 10.1056/NEJMoa0909545.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • replacement of an existing transvenouse ICD system
  • ACC/AHA/HRS Class I or II indications for ICD implantation
  • Age >= 18 years
  • Appropriate pre-operative 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
  • Remales 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 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
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
New Zealand
Not Provided
Not Provided
Stephen A. O'Connor, Ph.D., Hon FRCP - Director, Clinical and Regulatory Affairs, Cameron Health, Inc.
Boston Scientific Corporation
Not Provided
Study Director: Stephen O'Connor, PhD, Hon FRACP Boston Scientific Corporation
Boston Scientific Corporation
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP