Ignite Creation Date:
2024-05-05 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00614718
Status:
COMPLETED
Last Update Posted:
2008-02-13
First Post:
2008-01-30
Brief Title:
Failure of Chronically Implanted Defibrillator Leads -Incidence and Management
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Failure of Chronically Implanted Defibrillator Leads -Incidence and Management A Retrospective Multicenter Study
Status:
COMPLETED
Status Verified Date:
2008-01
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:
Comparison of two different approaches to address the problem of malfunctioning ICD-leads These leads consist of two parts One that is used for detection of arrhythmiasand pacing if required PaceSense and a second part that is used to deliver therapy is needed Shock-coil
The two approaches compared are
Replacement of the entire lead in case of any lead malfunction versus placement of an additional pacesense-lead if the shock-coil of the exiting lead was still functional
The two approaches compared are
Replacement of the entire lead in case of any lead malfunction versus placement of an additional pacesense-lead if the shock-coil of the exiting lead was still functional
Detailed Description:
Therapy with an implantable cardioverter defibrillator ICD has become a standard treatment for an increasing number of patients suffering from different types of heart diseases which can lead to fatal arrhythmias This therapy was established about 20 Years ago and malfunctioning electrodes of these devices have been and still are a serious problem leading to inappropriate therapy shocksor missed live saving therapy
In case of a malfunctioning electrode it is established clinical practice to either replace the entire ICD electrode which is used for detecting the arrhythmias as well as delivering the shock or just to implant an additional electrode for detection of the arrhythmia and pacing if required given that the shock-part of the existing electrode is still functional
There is no longterm outcome data comparing these two strategies We included 1317 consecutive patients with an ICD implanted at three European centers between 1993 and 2004 Incidence of lead failure type of lead used approach and outcome were evaluated
In case of a malfunctioning electrode it is established clinical practice to either replace the entire ICD electrode which is used for detecting the arrhythmias as well as delivering the shock or just to implant an additional electrode for detection of the arrhythmia and pacing if required given that the shock-part of the existing electrode is still functional
There is no longterm outcome data comparing these two strategies We included 1317 consecutive patients with an ICD implanted at three European centers between 1993 and 2004 Incidence of lead failure type of lead used approach and outcome were evaluated
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