DefibrillatorsNCT03521050
LUKS-Leads Registry on Long-term Performance of ICD Leads
An observational study of Defibrillators and Electrical Shock, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Defibrillators, Electrical Shock
- What is being tested?
- defibrillator lead
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2016to Dec 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a clinical indication for an ICD
Who may be able to join
- all patients being implanted with a Defibrillator lead from 2006 onwards
Who cannot join
- documented refusal of data collection for scientific purposes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Luzerner Heart Centre
Lucerne, 6000
Richard Kobza, MD, +41412055144, richard.kobza@luks.ch
About this study
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.
Read the 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
- Conditions
- Defibrillators, Electrical Shock
- Being tested
- defibrillator lead
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
defibrillator leadDevice
observation of long-term performance of defibrillator leads
| Study group | Role | What they receive |
|---|---|---|
| implanted defibrillator lead | patients having an ICD implanted and having follow-up at the investigators center Receives: Device: defibrillator lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance of lead impedance
electronic impedances in Ω
Measured: regular clinical controls within 10 years
performance of lead threshold
threshold values in V
Measured: during regular clinical controls within 10 years
performance of lead sensing
sensing values in millivolt (mV)
Measured: during regular clinical controls within 10 years
lead parameters
battery performance in %
Measured: during regular clinical controls within 10 years
performance of defibrillator
inadequate/adequate shock release in numbers
Measured: during regular clinical controls within 10 years
control system of defibrillator
software problems in numbers and descriptive
Measured: during regular clinical controls within 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study startDec 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DefibrillatorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Kobza, Luzerner Kantonsspital
- Investigators
- Richard Kobza, MD, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521050
- Sponsor's protocol ID
- 2016-02002
- Other IDs
- 2016
- Status last verified
- Sep 2020
- First submitted
- 27 Nov 2017
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUKS-Leads Registry on Long-term Performance of ICD Leads
- ClinicalTrials.gov ID
- NCT03521050
- Acronym / sponsor ID
- 2016-02002
- Conditions
- Defibrillators, Electrical Shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| implanted defibrillator lead | – | Device: defibrillator leadpatients having an ICD implanted and having follow-up at the investigators center |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a clinical indication for an ICD
Key inclusion criteria (1 listed)
- all patients being implanted with a Defibrillator lead from 2006 onwards
Key exclusion criteria (1 listed)
- documented refusal of data collection for scientific purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| defibrillator leadobservation of long-term performance of defibrillator leads | Device | implanted defibrillator lead |
Primary outcome
performance of lead impedance
Time frame: regular clinical controls within 10 years
electronic impedances in Ω
performance of lead threshold
Time frame: during regular clinical controls within 10 years
threshold values in V
performance of lead sensing
Time frame: during regular clinical controls within 10 years
sensing values in millivolt (mV)
lead parameters
Time frame: during regular clinical controls within 10 years
battery performance in %
performance of defibrillator
Time frame: during regular clinical controls within 10 years
inadequate/adequate shock release in numbers
control system of defibrillator
Time frame: during regular clinical controls within 10 years
software problems in numbers and descriptive
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Kobza, MD principal investigator
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Defibrillators and Electrical Shock, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard Kobza, MD (+41412055144, richard.kobza@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance of lead impedance (time frame: regular clinical controls within 10 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.