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Trial record 35 of 132 for:    "Paroxysmal Ventricular Fibrillation"

Failure of Chronically Implanted Defibrillator Leads -Incidence and Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00614718
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : February 13, 2008
Information provided by:
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.

Condition or disease
Death, Sudden, Cardiac Ventricular Fibrillation

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.

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Study Type : Observational
Actual Enrollment : 1317 participants
Observational Model: Case Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1317 consecutive patients with an ICD implanted at three European centers between 1993 and 2004

Inclusion Criteria:

  • Implantation of an ICD between 1993 and 2004

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00614718

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Herzzentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Benjamin Franklin, Division of Cardiology,
Berlin, Germany
University Hospital
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
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Principal Investigator: Christian Sticherling, MD University Hospital Basel, Dept. Cardiology

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Responsible Party: Christian Sticherling, MD, University Hospital Basel, Division of Cardiology Identifier: NCT00614718     History of Changes
Other Study ID Numbers: USB01
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: February 13, 2008
Last Verified: January 2008

Keywords provided by University Hospital, Basel, Switzerland:
Implantable cardioverter defibrillator
lead failure
pace/sense lead
ICD complication
inappropriate therapy

Additional relevant MeSH terms:
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Ventricular Fibrillation
Death, Sudden
Death, Sudden, Cardiac
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest