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Recruiting NCT03521050

LUKS-Leads Registry on Long-term Performance of ICD Leads

— Observational Defibrillators Electrical Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: defibrillator lead.
Who it may be relevant to
Registry conditions: Defibrillators, Electrical Shock. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

All patients having an ICD implanted and having follow-up at the investigators 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.

The following parameters will be measured during regular clinical controls: electronic impedances, threshold values, sensing values, battery performance, inadequate/adequate shock release und software problems

Interventions

  • Device defibrillator lead
    observation of long-term performance of defibrillator leads

Primary outcome measures

  • performance of lead impedance [Time frame: regular clinical controls within 10 years]
  • performance of lead threshold [Time frame: during regular clinical controls within 10 years]
  • performance of lead sensing [Time frame: during regular clinical controls within 10 years]
  • lead parameters [Time frame: during regular clinical controls within 10 years]
  • performance of defibrillator [Time frame: during regular clinical controls within 10 years]
  • control system of defibrillator [Time frame: during regular clinical controls within 10 years]

Eligibility criteria

Inclusion criteria

  • all patients being implanted with a Defibrillator lead from 2006 onwards

Exclusion criteria

  • documented refusal of data collection for scientific purposes

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Luzerner Heart Centre — Lucerne

Identifiers

NCT: NCT03521050 · 2016-02002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗