Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399217
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2006-11-10
Brief Title:
Further Acute Research of a Subcutaneous Implantable Defibrillator S-ICD System
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Acute Intra-operative Testing of Subcutaneous Implantable Defibrillator Emulator and Parasternal Electrode Acutely Implanted for Comparison With Transvenous System
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ICDfor 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
Detailed Description:
The objectives of this study are to further evaluate the S-ICD systems 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None