Safe Traction During Ongoing Lead Extraction Procedure (S... | NCT01847625

Studies
Safe Traction During Ongoing Lead Extraction Procedure (STOP)

NCT01847625

Sponsor

Deutsches Herzzentrum Muenchen

Status

Completed

Last Update Posted

Mar 20, 2023Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Electrode Malfunction
Infections of Cardiac Electronic Implantable Devices

Interventions

simulator

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Apr 9, 2013

First Submission Date that Met QC Criteria

May 2, 2013

First Posted Date

May 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2023

Last Update Posted Date

Mar 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Physicians experienced in lead extraction		Physicians experienced in lead extraction	Other: simulator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
simulator	Other		Physicians experienced in lead extraction

Measure	Description	Time Frame
Forces used for lead extraction		10 Minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Experience in pacemaker and defibrillator lead extraction

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Physicians experienced in pacemaker or defibrillator electrode extraction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deutsches Herzzentrum München		Munich	Bavaria	80636	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24967337	Result	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.