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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00614718
Other study ID # USB01
Secondary ID
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


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
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