NCT01847625

Brief Summary

The study will evaluate (in-vitro) the forces that are typically used for the extraction of pacemaker or defibrillator electrodes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

April 9, 2013

Last Update Submit

March 17, 2023

Conditions

Electrode MalfunctionInfections of Cardiac Electronic Implantable Devices

Outcome Measures

Primary Outcomes (1)

  • Forces used for lead extraction

    10 Minutes

Study Arms (1)

Physicians experienced in lead extraction

Physicians experienced in lead extraction

Other: simulator

Interventions

simulatorOTHER
Physicians experienced in lead extraction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Physicians experienced in pacemaker or defibrillator electrode extraction

You may qualify if:

  • Experience in pacemaker and defibrillator lead extraction

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

Location

Related Publications (1)

  • Lennerz C, Pavaci H, Grebmer C, von Olshausen G, Semmler V, Buiatti A, Reents T, Ammar S, Deisenhofer I, Kolb C. Forces applied during transvenous implantable cardioverter defibrillator lead removal. Biomed Res Int. 2014;2014:183483. doi: 10.1155/2014/183483. Epub 2014 May 21.

    PMID: 24967337RESULT

Study Design

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

Study Record Dates

First Submitted

April 9, 2013

First Posted

May 7, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations

DE(1)