Failure of Chronically Implanted Defibrillator Leads -Incidence and Management

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.

Completed

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Key information

Conditions

Death, Sudden, Cardiac Arrhythmias, Cardiac Cardiovascular Diseases Death Death, Sudden Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Fibrillation

Sex eligibility

All sexes

Study type

Observational

Primary location

Herzzentrum Bad Krozingen, Bad Krozingen, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Implantation of an ICD between 1993 and 2004

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Time to lead failure or lead failure recurrence

Time frame: from inclution to death or end of follow up (Jan 2004)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start: 1993
Primary completion: 2004
Study completion: 2007
First posted: Feb 13, 2008
Registry last updated: Feb 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed