Contemporary Transvenous Lead Extraction Outcomes (TLE)

May 2, 2022 updated by: Deutsches Herzzentrum Muenchen

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Munich, Bayern, Germany, 80636
        • Deutsches Herzzentrum München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing a lead extractions or lead explantation (defined by the EHRA consensus statement) procedure were prospectively enrolled in the database,

Description

Inclusion Criteria:

  • all patients undergoing a lead removal procedure

Exclusion Criteria:

  • minors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
acute setting (during the surgical procedure)
Percentage of patients undergoing TLE with major and minor complication
Time Frame: acute setting (during the surgical procedure)
procedure related major and minor complications
acute setting (during the surgical procedure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
long term outcome
Time Frame: >12months follow up
survival after TLE
>12months follow up
Percentage of patients encountering a major or minor sedation complication during TLE
Time Frame: acute setting (during the surgical procedure)
Complication of cardiologist-directed sedation during TLE procedures
acute setting (during the surgical procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Investigators

  • Principal Investigator: Carsten Lennerz, MD, German Heart Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

October 1, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GER-EP-025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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