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

Defibrillators Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03521050
• Other study ID #: 2016-02002
• Status: Recruiting
• Start date: December 2016
• Est. completion date: December 2026

Study information

• Verified date: September 2020
• Source: Luzerner Kantonsspital
• Contact: Richard Kobza, MD
• Phone: +41412055144
• Email: richard.kobza[@]luks.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• documented refusal of data collection for scientific purposes

Related Conditions & MeSH terms

• Defibrillators
• Electrical Shock

Intervention

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

Locations

Country	Name	City	State
Switzerland	Luzerner Heart Centre	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

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