Pacemaker Lead DysfunctionNCT07023900
Lead Extraction With Manual Traction
An observational study of Pacemaker Lead Dysfunction and Manual Traction, run by Bursa Postgraduate Hospital.
Trial summary
The number of implantable cardiac rhythm devices is increasing. As a result, the number of patients requiring lead extraction is increasing. In this study, authors aimed to present their experience with lead extraction using manual traction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pacemaker Lead Dysfunction, Manual Traction
- What is being tested?
- Manual traction
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 May 2023
- How long will I take part?
- 1 Month
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients who underwent transvenous lead extraction manually in our hospital.
Who may be able to join
- Patients, who underwent transvenous lead extraction manually
- Patients, who had lead and device types
Who cannot join
- Patients, who underwent transvenous lead extraction with extraction device
- Patients, who had not baseline characteristics
- Patients, who had not procedure detail
About this study
Official title: Transvenous Lead Removal Only With Manual Traction Without Extraction Tools
The number of implantable cardiac rhythm devices is increasing. As a result, the number of patients requiring lead extraction is increasing. In this study, authors aimed to present their experience with lead extraction using manual traction.
Read the detailed description
Objectives: The number of implantable cardiac rhythm devices is increasing. As a result, the number of patients requiring lead extraction is increasing. In this study, authors aimed to present our experience with lead extraction using manual traction.
Methods: Patients (n=130) who underwent lead extraction by manual traction without the use of lead extraction devices (extraction sheaths, locking stylets, etc.) manufactured for extraction at our hospital between 2016 and 2021 were reviewed. Patient characteristics, indications for extraction, procedural success, complications, and mortality were evaluated.
- Conditions
- Pacemaker Lead Dysfunction, Manual Traction
- Being tested
- Manual traction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual tractionOther
The pacemaker or ICD lead extraction with manually.
What is being measured
The primary outcome is the main question the study is designed to answer.
Extraction the pacemaker or ICD lead manually without complication.
The patients number of extraction of all lead and pacemaker generator components without major complications was defined as procedural success.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jan 2016
- Primary completion1 Dec 2021
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pacemaker Lead DysfunctionStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 130 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Bursa Postgraduate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ARI, Bursa Postgraduate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023900
- Sponsor's protocol ID
- BursaPH Lead
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available.
PubMed 28919379Bongiorni MG, Burri H, Deharo JC, Starck C, Kennergren C, Saghy L, Rao A, Tascini C, Lever N, Kutarski A, Fernandez Lozano I, Strathmore N, Costa R, Epstein L, Love C, Blomstrom-Lundqvist C; ESC Scientific Document Group. 2018 EHRA expert consensus statement on lead extraction: recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: endorsed by APHRS/HRS/LAHRS. Europace. 2018 Jul 1;20(7):1217. doi: 10.1093/europace/euy050. No abstract available.
PubMed 29566158
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvenous Lead Removal Only With Manual Traction Without Extraction Tools
- ClinicalTrials.gov ID
- NCT07023900
- Acronym / sponsor ID
- BursaPH Lead
- Conditions
- Pacemaker Lead Dysfunction, Manual Traction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Bursa Postgraduate HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 17 Jun 2025 (actual)
- 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 number of implantable cardiac rhythm devices is increasing. As a result, the number of patients requiring lead extraction is increasing. In this study, authors aimed to present their experience with lead extraction using manual traction.
Detailed description
Objectives: The number of implantable cardiac rhythm devices is increasing. As a result, the number of patients requiring lead extraction is increasing. In this study, authors aimed to present our experience with lead extraction using manual traction.
Methods: Patients (n=130) who underwent lead extraction by manual traction without the use of lead extraction devices (extraction sheaths, locking stylets, etc.) manufactured for extraction at our hospital between 2016 and 2021 were reviewed. Patient characteristics, indications for extraction, procedural success, complications, and mortality were evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent transvenous lead extraction manually in our hospital.
Key inclusion criteria (2 listed)
- Patients, who underwent transvenous lead extraction manually
- Patients, who had lead and device types
Key exclusion criteria (3 listed)
- Patients, who underwent transvenous lead extraction with extraction device
- Patients, who had not baseline characteristics
- Patients, who had not procedure detail
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 |
|---|---|---|
| Manual tractionThe pacemaker or ICD lead extraction with manually. | Other | – |
Primary outcome
Extraction the pacemaker or ICD lead manually without complication.
Time frame: one month
The patients number of extraction of all lead and pacemaker generator components without major complications was defined as procedural success.
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 17 Jun 2025.
- Background: PubMed 28919379Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available.
- Background: PubMed 29566158Bongiorni MG, Burri H, Deharo JC, Starck C, Kennergren C, Saghy L, Rao A, Tascini C, Lever N, Kutarski A, Fernandez Lozano I, Strathmore N, Costa R, Epstein L, Love C, Blomstrom-Lundqvist C; ESC Scientific Document Group. 2018 EHRA expert consensus statement on lead extraction: recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: endorsed by APHRS/HRS/LAHRS. Europace. 2018 Jul 1;20(7):1217. doi: 10.1093/europace/euy050. No abstract available.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker Lead Dysfunction and Manual Traction, run by Bursa Postgraduate Hospital.
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 2 inclusion and 3 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 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Extraction the pacemaker or ICD lead manually without complication. (time frame: one month). 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 NCT07023900, which also lists 2 linked publications.
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 17 Jun 2025.