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
  Purpose

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.


Condition Intervention
Ventricular Fibrillation
Ventricular Tachycardia
Device: Subcutaneous Implantable Defibrillator (S-ICD) system
Device: ICD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Intra-operative Testing of Subcutaneous Implantable Defibrillator Emulator and Parasternal Electrode, Acutely Implanted, for Comparison With Transvenous System

Resource links provided by NLM:


Further study details as provided by Cameron Health, Inc.:

Estimated Enrollment: 50
Study Start Date: November 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients requiring ICD therapy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399217

Locations
United Kingdom
Papworth Hospital NHS Trust
Papworth Everard, Cambridge, United Kingdom, CB3 8RE
Sponsors and Collaborators
Cameron Health, Inc.
Investigators
Principal Investigator: Andrew A Grace, MD, PhD Papworth Hospital
  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 O'Connor, Cameron Health, Inc.
ClinicalTrials.gov Identifier: NCT00399217     History of Changes
Other Study ID Numbers: DN-05290
Study First Received: November 10, 2006
Last Updated: May 18, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Cameron Health, Inc.:
subcutaneous ICD
ICD
DFT
Pacing threshold
Polarity

Additional relevant MeSH terms:
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014