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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03521050

Enrollment

1000

Registered

2018-05-11

Start date

2016-12-31

Completion date

2026-12-31

Last updated

2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defibrillators, Electrical Shock

Brief summary

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

DEVICEdefibrillator lead

observation of long-term performance of defibrillator leads

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* documented refusal of data collection for scientific purposes

Design outcomes

Primary

Measure	Time frame	Description
performance of lead impedance	regular clinical controls within 10 years	electronic impedances in Ω
performance of lead threshold	during regular clinical controls within 10 years	threshold values in V
performance of lead sensing	during regular clinical controls within 10 years	sensing values in millivolt (mV)
lead parameters	during regular clinical controls within 10 years	battery performance in %
performance of defibrillator	during regular clinical controls within 10 years	inadequate/adequate shock release in numbers
control system of defibrillator	during regular clinical controls within 10 years	software problems in numbers and descriptive

Countries

Switzerland

Contacts

Primary ContactRichard Kobza, MD

richard.kobza@luks.ch+41412055144

Backup ContactBrigitta Mehmann, PHD

brigitta.mehmann@luks.ch+41412052455

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026