Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-29 @ 7:24 PM
Study NCT ID:
NCT01117792
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2010-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
Status:
COMPLETED
Status Verified Date:
2021-07
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 primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: