Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180440
Status:
COMPLETED
Last Update Posted:
2009-03-26
First Post:
2005-09-12
Brief Title:
INSURE INcidence Free SUrvival Before and After Implantable Cardioverter Defibrillator ICD Replacement
Sponsor:
Guidant Corporation
Organization:
Guidant Corporation
Study Overview
Official Title:
INcidence Free SUrvival Before and After ICD Replacement
Status:
COMPLETED
Status Verified Date:
2009-03
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 INSURE trial is a multi-center prospective trial to collect information about adequate ICD therapies in ICD patients before and after their first elective ICD replacement
Detailed Description:
The INSURE trial is a multi-center prospective trial to collect information about adequate ICD therapies in ICD patients before after their first elective ICD replacement For this purpose all consecutive ICD patients will be included in the study whose first implanted device is replaced due to ICD battery depletion ie arrival at battery indicator ERI ICD replacements due to other reasons can be included if duration of first ICD implantation was 3 years All patients included in the trial are regularly followed up until delivery of their first adequate ICD therapy The collected data shall provide statistically valid information about the risk to patients who never have experienced adequate ICD therapy before the ICD replacement investigated in this study In the future these statistical risk data can give additional information to implanting physicians such as whether an ICD replacement can eventually be omitted in those patients who are at very low risk for the occurrence of ICD therapies All actually available GUIDANT ICDs with CE certificate can be implanted in this trial
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