Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775783
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2023-02-25
Brief Title:
Effectiveness Complications and Mortality of TLE in Patients
Sponsor:
Medical University of Silesia
Organization:
Medical University of Silesia
Study Overview
Official Title:
Effectiveness Complications and Mortality of Transvenous Lead Extraction in Patients With and Without Infections-Prospective Registry From a High-volume Center
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXTRACT
Brief 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 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 patients 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 381 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None