Pacemaker Lead DysfunctionTLENCT05037474
Contemporary Transvenous Lead Extraction Outcomes
An observational study of Pacemaker Lead Dysfunction and Pacemaker Electrode Infection, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
Presentation of procedural safety and outcomes data from a high volume TLE centre Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker Lead Dysfunction, Pacemaker Electrode Infection, ICD
- What is being tested?
- TLE group
- Type of treatment
- Surgery or procedure
- How many people
- 340 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing a lead extractions or lead explantation (defined by the EHRA consensus statement) procedure were prospectively enrolled in the database,
Who may be able to join
- all patients undergoing a lead removal procedure
Who cannot join
- minors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contemporary Mechanical Lead Extraction Outcomes From a High-volume Center: Patient Characteristics, Procedural Characteristics and Outcomes.
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.
- Being tested
- TLE group
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLE groupProcedure or surgery
all patients underwent a transvenous lead extraction/explantation (TLE) procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete or clinical successful lead removal
Removal of a lead or retention of a part less than 4cm
Measured: acute setting (during the surgical procedure)
Percentage of patients undergoing TLE with major and minor complication
procedure related major and minor complications
Measured: acute setting (during the surgical procedure)
Secondary outcomes (2)
long term outcome
survival after TLE
Measured: >12months follow up
Percentage of patients encountering a major or minor sedation complication during TLE
Complication of cardiologist-directed sedation during TLE procedures
Measured: acute setting (during the surgical procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start1 Apr 2020
- Primary completion1 Oct 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker Lead DysfunctionStudies 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
- Retrospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carsten Lennerz, MD, Principal investigator, German Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037474
- Sponsor's protocol ID
- GER-EP-025
- Acronym
- TLE
- Status last verified
- Aug 2021
- First submitted
- 31 Aug 2021
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contemporary Mechanical Lead Extraction Outcomes From a High-volume Center: Patient Characteristics, Procedural Characteristics and Outcomes.
- ClinicalTrials.gov ID
- NCT05037474
- Acronym / sponsor ID
- TLE / GER-EP-025
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Sep 2021 (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.
Presentation of procedural safety and outcomes data from a high volume TLE centre
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing a lead extractions or lead explantation (defined by the EHRA consensus statement) procedure were prospectively enrolled in the database,
Key inclusion criteria (1 listed)
- all patients undergoing a lead removal procedure
Key exclusion criteria (1 listed)
- minors
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 |
|---|---|---|
| TLE groupall patients underwent a transvenous lead extraction/explantation (TLE) procedure | Procedure or surgery | – |
Primary outcome
Percentage of patients with complete or clinical successful lead removal
Time frame: acute setting (during the surgical procedure)
Removal of a lead or retention of a part less than 4cm
Percentage of patients undergoing TLE with major and minor complication
Time frame: acute setting (during the surgical procedure)
procedure related major and minor complications
2 secondary outcomes
long term outcome
Time frame: >12months follow up
Percentage of patients encountering a major or minor sedation complication during TLE
Time frame: acute setting (during the surgical procedure)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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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. This study is not recruiting at the moment.
Carsten Lennerz, MD principal investigator
German Heart Center
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 Pacemaker Lead Dysfunction and Pacemaker Electrode Infection, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 6 May 2022. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with complete or clinical successful lead removal (time frame: acute setting (during the surgical procedure)). The study lists 2 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 6 May 2022.