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CompletedNCT07023900Updated Jun 17, 2025

Lead Extraction With Manual Traction

An observational study in Pacemaker Lead Dysfunction and Manual Traction, sponsored by Bursa Postgraduate Hospital. Completed. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by Bursa Postgraduate Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
130
Sex
All
01

Study 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 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.

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Conditions studied

  • Pacemaker Lead Dysfunction
  • Manual Traction
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In context

Lead sponsor

Bursa Postgraduate Hospital is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients who underwent transvenous lead extraction manually in our hospital.

Inclusion criteria

  • Patients, who underwent transvenous lead extraction manually
  • Patients, who had lead and device types

Exclusion criteria

Exclusion Criteria:

  • Patients, who underwent transvenous lead extraction with extraction device
  • Patients, who had not baseline characteristics
  • Patients, who had not procedure detail
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
130 participants (actual)
Target follow-up
1 Month
Patient registry
Yes

Interventions

  • OtherManual traction

    The pacemaker or ICD lead extraction with manually.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: one month

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Study locations

No study locations are listed for this record.

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References and documents

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 28919379 ↗
  • Bongiorni 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07023900
Lead sponsor
Bursa Postgraduate Hospital
Responsible party
Hasan ARI (Prof. Dr., Bursa Postgraduate Hospital) — Principal investigator
First posted
Jun 17, 2025
Start date
Jan 1, 2016
Primary completion
Dec 1, 2021
Completion
May 1, 2023
Last update
Jun 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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