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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|