Transvenous Lead ExtractionEXTRACTNCT05775783
Effectiveness, Complications, and Mortality of TLE in Patients.
An observational study of Transvenous Lead Extraction, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The number of devices for cardiac pacing and defibrillation has increased in recent years. However, although they have improved in terms of quality and extended lifespan after implantation, they are not free from complications. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Transvenous Lead Extraction
- What is being tested?
- Transvenous lead extraction
- Type of treatment
- Surgery or procedure
- How many people
- 702 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2016to 31 Jul 2025
- How long will I take part?
- 30 Days
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 702 patients
Who may be able to join
- Consecutive patients who underwent TLE between 2016 and 2025 entered the EXTRACT Registry.
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness, Complications, and Mortality of Transvenous Lead Extraction in Patients With and Without Infections-Prospective Registry From a High-volume Center.
The number of devices for cardiac pacing and defibrillation has increased in recent years. However, although they have improved in terms of quality and extended lifespan after implantation, they are not free from complications. The Achilles' heel of cardiac implantable electronic devices (CIEDs) is the risk of infections and lead failure, which, when untreated, can be the cause of poor outcomes and a high mortality rate. Abandoned leads predict serious adverse events, such as lead infections, death, electrical interference, or potential problems during future TLE procedures. Therefore, it is crucial to extract them, presuming the decision is warranted based on a patient's individual risk. TLE is a standard treatment for device-related complications, and while TLE procedures are relatively rare in comparison to the number of CIEDs that are implanted, the need for TLE has grown in recent years due to the aging population, an increasing number of upgrades of pacing systems, and a related rise in infection rates. According to the European Lead Extraction ConTRolled Registry (ELECTRa), the most frequent indication for TLE is CIED infection, with the majority of them being local infections. The second most common reason for TLE is lead dysfunction, which is observed in 38.1% of cases. In such cases, the treatment must be fast and effective. TLE is the first-line treatment for those patients and prevents further serious or even lethal complications. However, the goal of TLEis often to remove leads and also maintain access in the occluded vein by moving the sheath over the lead to the lead myocardial interface. TLE technology has recently shown substantial progress in improving the safety and effectiveness of the procedure. As a rule, single traction is the primary method of treatment, followed by more aggressive techniques such as locking stylet, mechanical sheaths, powered extraction sheaths, and femoral snares.
Data obtained in previous studies. indicated that identifying predictors of such undesirable adverse events appeared essential for optimizing the procedural technique. Another vital element to address were patients deemed at high risk of stricter follow-up and stronger secondary prevention strategies; notably, infected TLE patients have unique characteristics. The analysis of independent predictor outcomes could, thus, allow clinicians to better identify high-risk TLE patients. In light of this, the current registry aimed to investigate the composite short-term outcomes for infected and non-infected patients in real-world populations.
- Conditions
- Transvenous Lead Extraction
- Being tested
- Transvenous lead extraction
- Keywords
- Transvenous Lead Extraction, Cardiac Implantable Electronic Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvenous lead extractionProcedure or surgery
Each TLE procedure was started using the single traction method. If this attempt was not sufficient to extract the lead, then the following methods were used: mechanical extraction sheaths (Byrd, Cook Vascular Inc., Leechburg, PA, USA), locking and nonlocking stylets (Liberator® Beacon® Tip Locking Stylet, Cook® Medical, Leechburg, PA, USA), powered extraction sheaths (Evolution or Evolution II Mechanical Dilator Sheath, Cook® Medical, Leechburg, PA, USA). A side retrieval snare loop (Needle's Eye Snare, Cook® Medical, Leechburg, PA, USA) was used for the femoral approach when the subclavian-only approach was insufficient.
| Study group | Role | What they receive |
|---|---|---|
| Consecutive patients with CIEDs, treated with TLE (infections) | Not described Receives: Procedure: Transvenous lead extraction | |
| Consecutive patients with CIEDs, treated with TLE (no-infections) | Not described Receives: Procedure: Transvenous lead extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Removing all targeted leads and their component parts without causing any permanently disabling complication or procedure-related death.
Measured: 30 days
Clinical success
Removing all targeted leads and their component parts from the cardiovascular system or leaving a small part of the lead (<4cm) that did not adversely affect the objectives of the procedure or cause procedural-related death
Measured: 30 days
Minor complications
Complications that did not require surgical intervention or involved minor surgical interventions that did not affect the patient's functionality.
Measured: 30 days
All-cause death or occurrence of any major complication
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Jan 2016
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transvenous Lead ExtractionStudies 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
- Prospective
- Enrolment
- 702 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Wojciech Wańha
- Responsible party
- Principal investigator, Kszysztof Gołba, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775783
- Sponsor's protocol ID
- 0001
- Acronym
- EXTRACT
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Loboda D, Gladysz-Wanha S, Joniec M, Pilat E, Wojtyczka RD, Sarecka-Hujar B, Staron J, Swolana D, Gibinski M, Simionescu K, Wilczynski S, Golba KS. Drug-Resistant Gram-Positive Cocci as Etiological Factors of Cardiac Implantable Electronic Device Infections-Data from the EXTRACT Registry. Antibiotics (Basel). 2026 Mar 27;15(4):345. doi: 10.3390/antibiotics15040345.
PubMed 42041308
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Complications, and Mortality of Transvenous Lead Extraction in Patients With and Without Infections-Prospective Registry From a High-volume Center.
- ClinicalTrials.gov ID
- NCT05775783
- Acronym / sponsor ID
- EXTRACT / 0001
- Conditions
- Transvenous Lead Extraction
- Keywords
- Transvenous Lead Extraction, Cardiac Implantable Electronic Devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 702 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Wojciech Wańha
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 20 Mar 2023 (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.
The number of devices for cardiac pacing and defibrillation has increased in recent years. However, although they have improved in terms of quality and extended lifespan after implantation, they are not free from complications. The Achilles' heel of cardiac implantable electronic devices (CIEDs) is the risk of infections and lead failure, which, when untreated, can be the cause of poor outcomes and a high mortality rate. Abandoned leads predict serious adverse events, such as lead infections, death, electrical interference, or potential problems during future TLE procedures. Therefore, it is crucial to extract them, presuming the decision is warranted based on a patient's individual risk. TLE is a standard treatment for device-related complications, and while TLE procedures are relatively rare in comparison to the number of CIEDs that are implanted, the need for TLE has grown in recent years due to the aging population, an increasing number of upgrades of pacing systems, and a related rise in infection rates. According to the European Lead Extraction ConTRolled Registry (ELECTRa), the most frequent indication for TLE is CIED infection, with the majority of them being local infections. The second most common reason for TLE is lead dysfunction, which is observed in 38.1% of cases. In such cases, the treatment must be fast and effective. TLE is the first-line treatment for those patients and prevents further serious or even lethal complications. However, the goal of TLEis often to remove leads and also maintain access in the occluded vein by moving the sheath over the lead to the lead myocardial interface. TLE technology has recently shown substantial progress in improving the safety and effectiveness of the procedure. As a rule, single traction is the primary method of treatment, followed by more aggressive techniques such as locking stylet, mechanical sheaths, powered extraction sheaths, and femoral snares.
Data obtained in previous studies. indicated that identifying predictors of such undesirable adverse events appeared essential for optimizing the procedural technique. Another vital element to address were patients deemed at high risk of stricter follow-up and stronger secondary prevention strategies; notably, infected TLE patients have unique characteristics. The analysis of independent predictor outcomes could, thus, allow clinicians to better identify high-risk TLE patients. In light of this, the current registry aimed to investigate the composite short-term outcomes for infected and non-infected patients in real-world populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consecutive patients with CIEDs, treated with TLE (infections) | – | Procedure: Transvenous lead extraction |
| Consecutive patients with CIEDs, treated with TLE (no-infections) | – | Procedure: Transvenous lead extraction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 702 patients
Key inclusion criteria (1 listed)
- Consecutive patients who underwent TLE between 2016 and 2025 entered the EXTRACT Registry.
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| Transvenous lead extractionEach TLE procedure was started using the single traction method. If this attempt was not sufficient to extract the lead, then the following methods were used: mechanical extraction sheaths (Byrd, Cook Vascular Inc., Leechburg, PA, USA), locking and nonlocking stylets (Liberator® Beacon® Tip Locking Stylet, Cook® Medical, Leechburg, PA, USA), powered extraction sheaths (Evolution or Evolution II Mechanical Dilator Sheath, Cook® Medical, Leechburg, PA, USA). A side retrieval snare loop (Needle's Eye Snare, Cook® Medical, Leechburg, PA, USA) was used for the femoral approach when the subclavian-only approach was insufficient. | Procedure or surgery | Consecutive patients with CIEDs, treated with TLE (infections), Consecutive patients with CIEDs, treated with TLE (no-infections) |
Primary outcome
Procedural success
Time frame: 30 days
Removing all targeted leads and their component parts without causing any permanently disabling complication or procedure-related death.
Clinical success
Time frame: 30 days
Removing all targeted leads and their component parts from the cardiovascular system or leaving a small part of the lead (<4cm) that did not adversely affect the objectives of the procedure or cause procedural-related death
Minor complications
Time frame: 30 days
Complications that did not require surgical intervention or involved minor surgical interventions that did not affect the patient's functionality.
All-cause death or occurrence of any major complication
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 42041308Loboda D, Gladysz-Wanha S, Joniec M, Pilat E, Wojtyczka RD, Sarecka-Hujar B, Staron J, Swolana D, Gibinski M, Simionescu K, Wilczynski S, Golba KS. Drug-Resistant Gram-Positive Cocci as Etiological Factors of Cardiac Implantable Electronic Device Infections-Data from the EXTRACT Registry. Antibiotics (Basel). 2026 Mar 27;15(4):345. doi: 10.3390/antibiotics15040345.
- Individual participant dataSharing planned: Undecided
Related trials for Transvenous Lead Extraction
Not yet recruitingObservational study
Observational, Retrospective, Single-center Study Aimed at Evaluating Long-term Outcomes Following Transvenous Lead Extraction of Infected Cardiac Implantable Electronic Devices.
Cardiac Implantable Electronic Device (CIED)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Transvenous Lead Extraction, run by Medical University of Silesia at 1 site in Poland.
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: finished, as of the sponsor's last update on 21 Jan 2026. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Procedural success (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05775783, which also lists 1 linked publication.
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 21 Jan 2026.