ClinicalTrials.gg
Status unknownNCT05037474TLEUpdated May 6, 2022

Contemporary Transvenous Lead Extraction Outcomes

An observational study in Pacemaker Lead Dysfunction, Pacemaker Electrode Infection and ICD, sponsored by Deutsches Herzzentrum Muenchen. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-06.

Sponsored by Deutsches Herzzentrum Muenchen · Observational

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
340
Ages
18 Years and older
Sex
All
01

Study summary

Presentation of procedural safety and outcomes data from a high volume TLE centre

Read the detailed description

Transvenous lead extraction is crucial procedure in the longterm management of patients with implanted pacemakers or cardioverter defibrillators.

Our study presents the patient and procedural characteristics as well as the outcome data of a cohort undergoing transvenous lead extraction (TLE) with olny mechanical extraction tools at a high-volume TLE centre.

02

Conditions studied

  • Pacemaker Lead Dysfunction
  • Pacemaker Electrode Infection
  • ICD
  • Endocarditis Infective

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03

In context

Endocarditis

173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.

This study's enrollment of 340 is above the median of 225 across 82 observational studies indexed under Endocarditis.

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Lead sponsor

Deutsches Herzzentrum Muenchen is the lead sponsor of 114 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients undergoing a lead extractions or lead explantation (defined by the EHRA consensus statement) procedure were prospectively enrolled in the database,

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all patients undergoing a lead removal procedure

Exclusion criteria

Exclusion Criteria:

  • minors
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
340 participants (actual)
Patient registry
No

Interventions

  • ProcedureTLE group

    all patients underwent a transvenous lead extraction/explantation (TLE) procedure

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What researchers measure

Primary outcomes

  1. Percentage of patients with complete or clinical successful lead removal

    Removal of a lead or retention of a part less than 4cm

    Time frame: acute setting (during the surgical procedure)

  2. Percentage of patients undergoing TLE with major and minor complication

    procedure related major and minor complications

    Time frame: acute setting (during the surgical procedure)

Secondary outcomes

  1. long term outcome

    survival after TLE

    Time frame: >12months follow up

  2. Percentage of patients encountering a major or minor sedation complication during TLE

    Complication of cardiologist-directed sedation during TLE procedures

    Time frame: acute setting (during the surgical procedure)

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Study locations

1 site
  • Deutsches Herzzentrum München
    Munich, Bayern 80636, Germany
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2020 to primary completion in Oct 2021, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2021
First posted
Sep 8, 2021
StartActual
Apr 1, 2020
Primary completionActual
Oct 1, 2021
CompletionEst.
Dec 31, 2022
Last update
May 6, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05037474
Responsible party
Sponsor
First posted
Sep 8, 2021
Start date
Apr 1, 2020
Primary completion
Oct 1, 2021
Completion
Dec 31, 2022 (estimated)
Last update
May 6, 2022

Study contacts

Carsten Lennerz, MD
principal investigator · German Heart Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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