Death, Sudden, CardiacNCT00614718
Failure of Chronically Implanted Defibrillator Leads -Incidence and Management
An observational study of Death, Sudden, Cardiac and Ventricular Fibrillation, run by University Hospital, Basel, Switzerland at 3 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Death, Sudden, Cardiac, Ventricular Fibrillation
- How many people
- 1,317 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 1993to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1317 consecutive patients with an ICD implanted at three European centers between 1993 and 2004
Who may be able to join
- Implantation of an ICD between 1993 and 2004
Who cannot join
- None
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Herzzentrum Bad Krozingen
Bad Krozingen, 79189
Benjamin Franklin, Division of Cardiology,
Berlin
About this study
Official title: Failure of Chronically Implanted Defibrillator Leads -Incidence and Management A Retrospective Multicenter Study
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.
Read the 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.
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation
- Keywords
- Implantable cardioverter defibrillator, lead failure, pace/sense lead, ICD complication, inappropriate therapy, Defibrillators
- Medical subject headings
- Death, Sudden, Cardiac, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to lead failure or lead failure recurrence
Measured: from inclution to death or end of follow up (Jan 2004)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 1993
- Primary completionJan 2004
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Death, Sudden, CardiacStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,317 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Christian Sticherling, MD, Principal investigator, University Hospital Basel, Dept. Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614718
- Sponsor's protocol ID
- USB01
- Status last verified
- Jan 2008
- First submitted
- 30 Jan 2008
- Last updated
- 13 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Failure of Chronically Implanted Defibrillator Leads -Incidence and Management A Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT00614718
- Acronym / sponsor ID
- USB01
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation
- Keywords
- Implantable cardioverter defibrillator, lead failure, pace/sense lead, ICD complication, inappropriate therapy, Defibrillators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,317 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 1993
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1317 consecutive patients with an ICD implanted at three European centers between 1993 and 2004
Key inclusion criteria (1 listed)
- Implantation of an ICD between 1993 and 2004
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to lead failure or lead failure recurrence
Time frame: from inclution to death or end of follow up (Jan 2004)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Sticherling, MD principal investigator
University Hospital Basel, Dept. Cardiology
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death, Sudden, Cardiac and Ventricular Fibrillation, run by University Hospital, Basel, Switzerland at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to lead failure or lead failure recurrence (time frame: from inclution to death or end of follow up (Jan 2004)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2008.