NCT05775783: EXTRACT

Effectiveness, Complications, and Mortality of TLE in Patients.

Completed Last updated 21 January 2026

What this trial tests

trial testing Transvenous lead extraction in Transvenous Lead Extraction in 702 participants. Completed in 31 July 2025.

Timeline

1 January 2016

Primary endpoint
31 July 2025

31 July 2025

Quick facts

Lead sponsor	Medical University of Silesia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	702
Start date	1 January 2016
Primary completion	31 July 2025
Estimated completion	31 July 2025
Sites	1 location across Poland

Drugs / interventions tested

• Transvenous lead extraction

Conditions studied

• Transvenous Lead Extraction — all drugs for Transvenous Lead Extraction →

Sponsor

Medical University of Silesia

Who can join

Eligibility, any sex, with Transvenous Lead Extraction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extraction of lumenless pacing leads from the His bundle and left bundle branch area: outcomes of the high-volume centre.
   Gardas R, Loboda D, Biernat J, Soral T, et al · · 2024 · cited 2× · PMID 39137240 · DOI 10.1093/europace/euae213
2. Drug-Resistant Gram-Positive Cocci as Etiological Factors of Cardiac Implantable Electronic Device Infections-Data from the EXTRACT Registry.
   Łoboda D, Gładysz-Wańha S, Joniec M, Piłat E, et al · · 2026 · PMID 42041308 · DOI 10.3390/antibiotics15040345
3. Transvenous Lead Extraction Complicated by Lead Breakage: A Predictive Model Based on Analysis of the EXTRACT Registry.
   Joniec M, Stachanczyk J, Gardas R, Gladysz-Wanha S, et al · · 2026 · PMID 41682899 · DOI 10.3390/jcm15031216
4. Symptomatic Deep Venous Thrombosis of the Upper Extremity Following Transvenous Lead Extraction, Data From EXTRACT Registry.
   Joniec M, Stachanczyk J, Gladysz-Wanha S, Pilat E, et al · · 2026 · PMID 41517909 · DOI 10.1111/jce.70243