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Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System

This study has been completed.
Sponsor:
Information provided by:
Cameron Health, Inc.
ClinicalTrials.gov Identifier:
NCT00399217
First received: November 10, 2006
Last updated: May 18, 2010
Last verified: May 2010

November 10, 2006
May 18, 2010
November 2006
June 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00399217 on ClinicalTrials.gov Archive Site
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Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System
Acute Intra-operative Testing of Subcutaneous Implantable Defibrillator Emulator and Parasternal Electrode, Acutely Implanted, for Comparison With Transvenous System

The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter defibrillator (ICD)for treating ventricular tachyarrhythmias. The S-ICD electrode and pulse generator emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, but then the S-ICD system will be removed entirely.

The objectives of this study are to further evaluate the S-ICD system's ability to identify and terminate induced ventricular tachyarrhythmias in patients acutely with an S-ICD emulator and parasternal electrode during the implant procedure of a standard transvenous ICD.

The active emulator is not a powered medical device and all elements of the test system are removed following the testing.

This acute intra-operative protocol will test the ability of the electrode and emulator to appropriately convert the arrhythmia and allos an assessment of post shock pacing.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

patients requiring ICD therapy

  • Ventricular Fibrillation
  • Ventricular Tachycardia
  • Device: Subcutaneous Implantable Defibrillator (S-ICD) system
  • Device: ICD
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. Epub 2010 May 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients requiring ICD therapy according to National Centre for Clinical Excellence (NICE) criteria are eligible
  • And patients who require replacement of an existing transvenous ICD system are eligible

Exclusion Criteria:

  • Patients unable or unwilling to provide informed consent
  • Any conditions which precludes the subject's ability to comply with the study requirements, including completion of the study
  • 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 this study
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00399217
DN-05290
Not Provided
Stephen O'Connor, Cameron Health, Inc.
Cameron Health, Inc.
Not Provided
Principal Investigator: Andrew A Grace, MD, PhD Papworth Hospital
Cameron Health, Inc.
May 2010

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