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

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ClinicalTrials.gov Identifier: NCT03521050
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Kobza, Luzerner Kantonsspital

Brief Summary:
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 propspectively 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
Defibrillators Electrical Shock 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 propspectively 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 [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: LUKS-Leads Registry on Long-term Performance of ICD Leads
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

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




Primary Outcome Measures :
  1. performance of lead impedance [ Time Frame: regular clincial controls within 10 years ]
    electronic impedances in Ω

  2. performance of lead threshold [ Time Frame: during regular clincial controls within 10 years ]
    threshold values in V

  3. performance of lead sensing [ Time Frame: during regular clincial controls within 10 years ]
    sensing values in mV

  4. lead parameters [ Time Frame: during regular clincial controls within 10 years ]
    battery performance in %

  5. performance of defibrillator [ Time Frame: during regular clincial controls within 10 years ]
    inadequate/adequate shock release in numbers

  6. control system of defibrillator [ Time Frame: during regular clincial controls within 10 years ]
    software problems in numbers and desceptive



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a clinical indication for an ICD
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • documented refusal of data collection for scientific purposes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521050


Contacts
Contact: Richard Kobza, MD +41412055144 richard.kobza@luks.ch
Contact: Brigitta Mehmann, PHD +41412052455 brigitta.mehmann@luks.ch

Locations
Switzerland
Luzerner Heart Centre Recruiting
Lucerne, Switzerland, 6000
Contact: Richard Kobza, MD    +41412055144    richard.kobza@luks.ch   
Sponsors and Collaborators
Luzerner Kantonsspital
Investigators
Principal Investigator: Richard Kobza, MD Luzerner Kantonsspital

Responsible Party: Richard Kobza, PD Dr. med., Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT03521050     History of Changes
Other Study ID Numbers: 2016-02002
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No