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NCT Number: NCT03521050

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

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.

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Key information

Conditions

Defibrillators Electrical Shock

Sex eligibility

All sexes

Study type

Observational

Primary location

Luzerner Heart Centre

Lucerne, 6000, Switzerland

Location status: Recruiting

Location contact

Richard Kobza, MD

CONTACT

[email protected]

+41412055144

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • documented refusal of data collection for scientific purposes

Treatment and study plan

defibrillator lead

Device

observation of long-term performance of defibrillator leads

Primary outcomes

  1. performance of lead impedance

    Time frame: regular clinical controls within 10 years

    electronic impedances in Ω

  2. performance of lead threshold

    Time frame: during regular clinical controls within 10 years

    threshold values in V

  3. performance of lead sensing

    Time frame: during regular clinical controls within 10 years

    sensing values in millivolt (mV)

  4. lead parameters

    Time frame: during regular clinical controls within 10 years

    battery performance in %

  5. performance of defibrillator

    Time frame: during regular clinical controls within 10 years

    inadequate/adequate shock release in numbers

  6. control system of defibrillator

    Time frame: during regular clinical controls within 10 years

    software problems in numbers and descriptive

Study contacts

Contact information is provided by the study sponsor or research team.

Brigitta Mehmann, PHD

CONTACT

[email protected]

+41412052455

Richard Kobza, MD

CONTACT

[email protected]

+41412055144

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
May 11, 2018
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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