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

Sponsor
Luzerner Kantonsspital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03521050
Collaborator
(none)
1,000
Enrollment
1
Location
120
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: defibrillator lead

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
LUKS-Leads Registry on Long-term Performance of ICD Leads
Actual Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. performance of lead impedance [regular clinical controls within 10 years]

    electronic impedances in Ω

  2. performance of lead threshold [during regular clinical controls within 10 years]

    threshold values in V

  3. performance of lead sensing [during regular clinical controls within 10 years]

    sensing values in millivolt (mV)

  4. lead parameters [during regular clinical controls within 10 years]

    battery performance in %

  5. performance of defibrillator [during regular clinical controls within 10 years]

    inadequate/adequate shock release in numbers

  6. control system of defibrillator [during regular clinical controls within 10 years]

    software problems in numbers and descriptive

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • all patients being implanted with a Defibrillator lead from 2006 onwards
Exclusion Criteria:
  • documented refusal of data collection for scientific purposes

Contacts and Locations

Locations

Site City State Country Postal Code
1 Luzerner Heart Centre Lucerne Switzerland 6000

Sponsors and Collaborators

  • Luzerner Kantonsspital

Investigators

  • Principal Investigator: Richard Kobza, MD, Luzerner Kantonsspital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Richard Kobza, PD Dr. med., Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT03521050
Other Study ID Numbers:
  • 2016-02002
First Posted:
May 11, 2018
Last Update Posted:
Sep 4, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 4, 2020