Lead Extraction With Manual Traction
Transvenous Lead Removal Only With Manual Traction Without Extraction Tools
1 other identifier
observational
130
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2016
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 1, 2025
CompletedFirst Posted
Study publicly available on registry
June 17, 2025
CompletedJune 17, 2025
June 1, 2025
5.9 years
June 1, 2025
June 14, 2025
Conditions
Outcome Measures
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.
one month
Interventions
The pacemaker or ICD lead extraction with manually.
Eligibility Criteria
Patients who underwent transvenous lead extraction manually in our hospital.
You may qualify if:
- Patients, who underwent transvenous lead extraction manually
- Patients, who had lead and device types
You may not qualify if:
- Patients, who underwent transvenous lead extraction with extraction device
- Patients, who had not baseline characteristics
- Patients, who had not procedure detail
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 28919379BACKGROUNDBongiorni 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.
PMID: 29566158BACKGROUND
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
June 1, 2025
First Posted
June 17, 2025
Study Start
January 1, 2016
Primary Completion
December 1, 2021
Study Completion
May 1, 2023
Last Updated
June 17, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share