Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System
|ClinicalTrials.gov Identifier: NCT00399217|
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : February 16, 2017
|Condition or disease||Intervention/treatment|
|Ventricular Fibrillation Ventricular Tachycardia||Device: Subcutaneous Implantable Defibrillator (S-ICD) system Device: ICD|
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.
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|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|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
U.S. FDA Resources
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399217
|Papworth Hospital NHS Trust|
|Papworth Everard, Cambridge, United Kingdom, CB3 8RE|
|Principal Investigator:||Andrew A Grace, MD, PhD||Papworth Hospital|