Failure of Chronically Implanted Defibrillator Leads -Incidence and Management

NCT ID: NCT00614718

Last Updated: 2008-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1317 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1993-01-31
• Study Completion Date: 2007-01-31

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.

Conditions

Death, Sudden, Cardiac; Ventricular Fibrillation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

1

Total number of patients receiving an ICD between 1993 and 2004 and not having re interventions due to malfunctioning leads.

No interventions assigned to this group

2

Patients with ICD lead failure receiving a new ICD lead

No interventions assigned to this group

3

Patients with ICD lead failure but intact shock-coil of the ICD lead receiving only an additional pace/sense lead.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Implantation of an ICD between 1993 and 2004

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Basel, Division of Cardiology

Principal Investigators

Christian Sticherling, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Dept. Cardiology

Locations

Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

Benjamin Franklin, Division of Cardiology,

Berlin, , Germany

University Hospital

Basel, , Switzerland

Countries

Germany; Switzerland

Other Identifiers

USB01

Identifier Type: -

Identifier Source: org_study_id