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

NCT03521050 | Recruiting

• 1 other identifier: 2016-02002
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Defibrillators; Electrical Shock

Outcome Measures

Primary Outcomes (6)

• performance of lead impedance

  electronic impedances in Ω

  regular clinical controls within 10 years

• performance of lead threshold

  threshold values in V

  during regular clinical controls within 10 years

• performance of lead sensing

  sensing values in millivolt (mV)

  during regular clinical controls within 10 years

• lead parameters

  battery performance in %

  during regular clinical controls within 10 years

• performance of defibrillator

  inadequate/adequate shock release in numbers

  during regular clinical controls within 10 years

• control system of defibrillator

  software problems in numbers and descriptive

  during regular clinical controls within 10 years

Study Arms (1)

implanted defibrillator lead

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

Device: defibrillator lead

Interventions

defibrillator lead DEVICE

observation of long-term performance of defibrillator leads

implanted defibrillator lead

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a clinical indication for an ICD

You may qualify if:

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

You may not qualify if:

• documented refusal of data collection for scientific purposes

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Luzerner Heart Centre

Lucerne, 6000, Switzerland

RECRUITING

MeSH Terms

Interventions

Device Lead Extraction

Intervention Hierarchy (Ancestors)

Device Removal; Surgical Procedures, Operative

Study Officials

• Richard Kobza, MD

  Luzerner Kantonsspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Kobza, MD

CONTACT

+41412055144; richard.kobza@luks.ch

Brigitta Mehmann, PHD

CONTACT

+41412052455; brigitta.mehmann@luks.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: May 11, 2018
• Study Start: December 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)