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

Recruiting

• Conditions: Defibrillators; Electrical Shock

• Registration Number: NCT03521050
• Lead Sponsor: Luzerner Kantonsspital

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

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2018-04-27
• Study First Posted: 2018-05-11
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• documented refusal of data collection for scientific purposes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
performance of lead impedance	regular clinical controls within 10 years	electronic impedances in Ω
performance of lead sensing	during regular clinical controls within 10 years	sensing values in millivolt (mV)
performance of lead threshold	during regular clinical controls within 10 years	threshold values in V
control system of defibrillator	during regular clinical controls within 10 years	software problems in numbers and descriptive
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

Trial Locations

Locations (1)

Luzerner Heart Centre; 🇨🇭 Lucerne, Switzerland