LUKS-Leads Registry on Long-term Performance of ICD Leads
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLuzerner Kantonsspital
About this trial
All patients having an implantable cardiac defibrillator (ICD) implanted and having follow-up at the Cantonal Hospital Lucerne (LUKS), the investigator center, are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
all patients being implanted with a Defibrillator lead from 2006 onwards
Disqualifiers
documented refusal of data collection for scientific purposes
Trial population
Patients with a clinical indication for an ICD
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
defibrillator lead
Deviceobservation of long-term performance of defibrillator leads
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: implanted defibrillator lead1 intervention
Trial outcomes
Primary outcomes
1
performance of lead impedance
electronic impedances in Ω
Time frame
regular clinical controls within 10 years2
performance of lead threshold
threshold values in V
Time frame
during regular clinical controls within 10 years3
performance of lead sensing
sensing values in millivolt (mV)
Time frame
during regular clinical controls within 10 years4
lead parameters
battery performance in %
Time frame
during regular clinical controls within 10 yearsSponsors and contacts
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Source ClinicalTrials.gov