Failure of Chronically Implanted Defibrillator Leads -Incidence and Management

Ventricular Fibrillation Clinical Trial

Official title:

Failure of Chronically Implanted Defibrillator Leads -Incidence and Management A Retrospective Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614718
• Other study ID #: USB01
• Status: Completed
• Phase: N/A
• First received: January 30, 2008
• Last updated: February 12, 2008
• Start date: January 1993
• Est. completion date: January 2007

Study information

• Verified date: January 2008
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1317
• Est. completion date: January 2007
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Implantation of an ICD between 1993 and 2004

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Death, Sudden
• Death, Sudden, Cardiac
• Ventricular Fibrillation

Locations

Country	Name	City	State
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Benjamin Franklin, Division of Cardiology,	Berlin
Switzerland	University Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to lead failure or lead failure recurrence		from inclution to death or end of follow up (Jan 2004)	Yes