Failure of Chronically Implanted Defibrillator Leads -Incidence and Management

Completed

• Conditions: Death, Sudden, Cardiac; Ventricular Fibrillation

• Registration Number: NCT00614718
• Lead Sponsor: University Hospital, Basel, Switzerland

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 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.

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 (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 Timeline

• Study Start: 1993-01
• Primary Completion: 2004-01
• Study Completion: 2007-01
• Status Verified: 2008-01
• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-02-12
• Last Update Submitted: 2008-02-12
• Study First Posted: 2008-02-13
• Last Update Posted: 2008-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1317

Inclusion Criteria

• Implantation of an ICD between 1993 and 2004

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to lead failure or lead failure recurrence	from inclution to death or end of follow up (Jan 2004)

Trial Locations

Locations (3)

University Hospital; 🇨🇭 Basel, Switzerland

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Benjamin Franklin, Division of Cardiology,; 🇩🇪 Berlin, Germany