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

This study has been completed.
Sponsor:
Information provided by:
Cameron Health, Inc.
ClinicalTrials.gov Identifier:
NCT00853645
First received: February 27, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Cameron Health, Inc.:

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853645

Locations
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1001
Christchurch Hospital
Christchurch, New Zealand, 8140
Sponsors and Collaborators
Cameron Health, Inc.
Investigators
Study Director: Stephen O'Connor, PhD, Hon FRACP Cameron Health, Inc.
  More Information

No publications provided by Cameron Health, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen A. O'Connor, Ph.D., Hon FRCP - Director, Clinical and Regulatory Affairs, Cameron Health, Inc.
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on July 24, 2014