NCT05037474

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 6, 2022

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

August 31, 2021

Last Update Submit

May 2, 2022

Conditions

Pacemaker Lead DysfunctionPacemaker Electrode InfectionICDEndocarditis Infective

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Percentage of patients undergoing TLE with major and minor complication

    procedure related major and minor complications

    acute setting (during the surgical procedure)

Secondary Outcomes (2)

  • long term outcome

    >12months follow up

  • Percentage of patients encountering a major or minor sedation complication during TLE

    acute setting (during the surgical procedure)

Interventions

TLE groupPROCEDURE

all patients underwent a transvenous lead extraction/explantation (TLE) procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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,

You may qualify if:

  • all patients undergoing a lead removal procedure

You may not qualify if:

  • minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

Location

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Carsten Lennerz, MD

    German Heart Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 8, 2021

Study Start

April 1, 2020

Primary Completion

October 1, 2021

Study Completion

December 31, 2022

Last Updated

May 6, 2022

Record last verified: 2021-08

Locations

DE(1)