Failure of Chronically Implanted Defibrillator Leads -Incidence and Management
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|ClinicalTrials.gov Identifier: NCT00614718|
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : February 13, 2008
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 arrhythmias(and pacing if required) (Pace/Sense) 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 pace/sense-lead if the shock-coil of the exiting lead was still functional.
|Condition or disease|
|Death, Sudden, Cardiac Ventricular Fibrillation|
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 (shocks)or 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.
|Study Type :||Observational|
|Actual Enrollment :||1317 participants|
|Observational Model:||Case Control|
|Official Title:||Failure of Chronically Implanted Defibrillator Leads -Incidence and Management A Retrospective Multicenter Study|
|Study Start Date :||January 1993|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||January 2007|
Total number of patients receiving an ICD between 1993 and 2004 and not having re interventions due to malfunctioning leads.
Patients with ICD lead failure receiving a new ICD lead
Patients with ICD lead failure but intact shock-coil of the ICD lead receiving only an additional pace/sense lead.
- Time to lead failure or lead failure recurrence [ Time Frame: from inclution to death or end of follow up (Jan 2004) ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614718
|Herzzentrum Bad Krozingen|
|Bad Krozingen, Germany, 79189|
|Benjamin Franklin, Division of Cardiology,|
|Basel, Switzerland, 4031|
|Principal Investigator:||Christian Sticherling, MD||University Hospital Basel, Dept. Cardiology|