LUKS-Leads Registry on Long-term Performance of ICD Leads | NCT03521050

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

NCT03521050

Sponsor

Luzerner Kantonsspital

Status

Recruiting

Last Update Posted

Sep 4, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Defibrillators
Electrical Shock

Interventions

defibrillator lead

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Nov 27, 2017

First Submission Date that Met QC Criteria

Apr 27, 2018

First Posted Date

May 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2020

Last Update Posted Date

Sep 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
implanted defibrillator lead		patients having an ICD implanted and having follow-up at the investigators center	Device: defibrillator lead

Interventions

Name	Type	Description	Arm Group Labels	Other Names
defibrillator lead	Device	observation of long-term performance of defibrillator leads	implanted defibrillator lead

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients being implanted with a Defibrillator lead from 2006 onwards

Exclusion Criteria:

documented refusal of data collection for scientific purposes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with a clinical indication for an ICD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Richard Kobza, MD	Contact	+41412055144		richard.kobza@luks.ch
Brigitta Mehmann, PHD	Contact	+41412052455		brigitta.mehmann@luks.ch

Overall Officials

Name	Affiliation	Role
Richard Kobza, MD	Luzerner Kantonsspital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Luzerner Heart Centre	Recruiting	Lucerne		6000	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000098523	Device Lead Extraction

Ancestor Terms

ID	Term
D020878	Device Removal
D013514	Surgical Procedures, Operative

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