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NCT05037474 Clinical Trial

Contemporary Transvenous Lead Extraction Outcomes

ICD Clinical Trial

— TLE  

Official title:
Contemporary Mechanical Lead Extraction Outcomes From a High-volume Center: Patient Characteristics, Procedural Characteristics and Outcomes.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05037474
Other study ID # GER-EP-025
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date December 31, 2022

Study information
Verified date August 2021
Source Deutsches Herzzentrum Muenchen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 340
Est. completion date December 31, 2022
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - all patients undergoing a lead removal procedure Exclusion Criteria: - minors

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• TLE group
all patients underwent a transvenous lead extraction/explantation (TLE) procedure

Locations
Country Name City State
Germany Deutsches Herzzentrum München Munich Bayern

Sponsors (1)
Lead Sponsor Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with complete or clinical successful lead removal Removal of a lead or retention of a part less than 4cm acute setting (during the surgical procedure)
Primary Percentage of patients undergoing TLE with major and minor complication procedure related major and minor complications acute setting (during the surgical procedure)
Secondary long term outcome survival after TLE >12months follow up
Secondary Percentage of patients encountering a major or minor sedation complication during TLE Complication of cardiologist-directed sedation during TLE procedures acute setting (during the surgical procedure)
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