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

September 2, 2020 updated by: Richard Kobza, Luzerner Kantonsspital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a clinical indication for an ICD

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • documented refusal of data collection for scientific purposes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
implanted defibrillator lead
patients having an ICD implanted and having follow-up at the investigators center
Device: defibrillator lead
observation of long-term performance of defibrillator leads

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luzerner Kantonsspital

Investigators

  • Principal Investigator: Richard Kobza, MD, Luzerner Kantonsspital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

April 27, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-02002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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