Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) 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.
Device: Subcutaneous Implantable Defibrillator (S-ICD) system
|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|
|Study Start Date:||November 2006|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399217
|Papworth Hospital NHS Trust|
|Papworth Everard, Cambridge, United Kingdom, CB3 8RE|
|Principal Investigator:||Andrew A Grace, MD, PhD||Papworth Hospital|