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

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ClinicalTrials.gov Identifier: NCT00853645
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
ACC/AHA/HRS Class I and II Indications for ICD Implantation Device: Subcutaneous Implantable Defibrillator (S-ICD) System

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Initial Chronic Human Validation Study: Subcutaneous Implantable (S-ICD) System
Study Start Date : July 2008
Primary Completion Date : September 2008
Study Completion Date : September 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: S-ICD System
Single-arm with 6 patients implanted with an S-ICD System
Device: Subcutaneous Implantable Defibrillator (S-ICD) System


Outcome Measures

Primary Outcome Measures :
  1. Induced VF conversion efficacy [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853645


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