Failure of Chronically Implanted Defibrillator Leads -Incidence and Management

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00614718
First received: January 30, 2008
Last updated: February 12, 2008
Last verified: January 2008
  Purpose

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
Death, Sudden, Cardiac
Ventricular Fibrillation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Failure of Chronically Implanted Defibrillator Leads -Incidence and Management A Retrospective Multicenter Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Time to lead failure or lead failure recurrence [ Time Frame: from inclution to death or end of follow up (Jan 2004) ] [ Designated as safety issue: Yes ]

Enrollment: 1317
Study Start Date: January 1993
Study Completion Date: January 2007
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Total number of patients receiving an ICD between 1993 and 2004 and not having re interventions due to malfunctioning leads.
2
Patients with ICD lead failure receiving a new ICD lead
3
Patients with ICD lead failure but intact shock-coil of the ICD lead receiving only an additional pace/sense lead.

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.

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • Implantation of an ICD between 1993 and 2004

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614718

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

No publications provided

Responsible Party: Christian Sticherling, MD, University Hospital Basel, Division of Cardiology
ClinicalTrials.gov Identifier: NCT00614718     History of Changes
Other Study ID Numbers: USB01
Study First Received: January 30, 2008
Last Updated: February 12, 2008
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on April 22, 2014