Electrode MalfunctionSTOPNCT01847625
Safe Traction During Ongoing Lead Extraction Procedure (STOP)
An observational study of Electrode Malfunction and Infections of Cardiac Electronic Implantable Devices, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
The study will evaluate (in-vitro) the forces that are typically used for the extraction of pacemaker or defibrillator electrodes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electrode Malfunction, Infections of Cardiac Electronic Implantable Devices
- What is being tested?
- simulator
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physicians experienced in pacemaker or defibrillator electrode extraction
Who may be able to join
- Experience in pacemaker and defibrillator lead extraction
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safe Traction During Ongoing Lead Extraction Procedure
The study will evaluate (in-vitro) the forces that are typically used for the extraction of pacemaker or defibrillator electrodes.
- Being tested
- simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulatorOther
| Study group | Role | What they receive |
|---|---|---|
| Physicians experienced in lead extraction | Physicians experienced in lead extraction Receives: Other: simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forces used for lead extraction
Measured: 10 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electrode MalfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847625
- Sponsor's protocol ID
- GER-EP-011
- Acronym
- STOP
- Status last verified
- Mar 2023
- First submitted
- 9 Apr 2013
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24967337
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Traction During Ongoing Lead Extraction Procedure
- ClinicalTrials.gov ID
- NCT01847625
- Acronym / sponsor ID
- STOP / GER-EP-011
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate (in-vitro) the forces that are typically used for the extraction of pacemaker or defibrillator electrodes.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physicians experienced in lead extraction | – | Other: simulatorPhysicians experienced in lead extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians experienced in pacemaker or defibrillator electrode extraction
Key inclusion criteria (1 listed)
- Experience in pacemaker and defibrillator lead extraction
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simulator | Other | Physicians experienced in lead extraction |
Primary outcome
Forces used for lead extraction
Time frame: 10 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Results publication: PubMed 24967337Lennerz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrode Malfunction and Infections of Cardiac Electronic Implantable Devices, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forces used for lead extraction (time frame: 10 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01847625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.