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

NCT ID: NCT03521050

Last Updated: 2020-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2026-12-31

Brief Summary

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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

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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

Conditions

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Defibrillators Electrical Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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implanted defibrillator lead

patients having an ICD implanted and having follow-up at the investigators center

defibrillator lead

Intervention Type DEVICE

observation of long-term performance of defibrillator leads

Interventions

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defibrillator lead

observation of long-term performance of defibrillator leads

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* documented refusal of data collection for scientific purposes
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luzerner Kantonsspital

OTHER

Sponsor Role lead

Responsible Party

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Richard Kobza

PD Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Kobza, MD

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital

Locations

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Luzerner Heart Centre

Lucerne, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Richard Kobza, MD

Role: CONTACT

+41412055144

Brigitta Mehmann, PHD

Role: CONTACT

+41412052455

Facility Contacts

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Richard Kobza, MD

Role: primary

+41412055144

Other Identifiers

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2016-02002

Identifier Type: -

Identifier Source: org_study_id

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