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
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.

Condition Intervention
ACC/AHA/HRS Class I and II Indications for ICD Implantation
Device: Subcutaneous Implantable Defibrillator (S-ICD) System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Initial Chronic Human Validation Study: Subcutaneous Implantable (S-ICD) System

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Induced VF conversion efficacy

Study Start Date: July 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00853645

New Zealand
Auckland City Hospital
Auckland, New Zealand, 1001
Christchurch Hospital
Christchurch, New Zealand, 8140
Sponsors and Collaborators
Boston Scientific Corporation
Study Director: Stephen O'Connor, PhD, Hon FRACP Boston Scientific Corporation
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stephen A. O'Connor, Ph.D., Hon FRCP - Director, Clinical and Regulatory Affairs, Cameron Health, Inc. Identifier: NCT00853645     History of Changes
Other Study ID Numbers: DN-11398 
Study First Received: February 27, 2009
Last Updated: February 27, 2009
Health Authority: New Zealand: Medsafe processed this record on May 26, 2016