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NCT03842124 · ClinicalTrials.gov registry record · NA
Improving Safety of Lead Extraction Procedures by Traction Force Sensing
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT03842124: Completed NA study, sponsored by Mayo Clinic.
NCT03842124 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03842124, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
Death and vascular tears occur in up to 1% of the patients undergoing lead extraction procedures. These complications are due to abnormal force vectors during the procedure. The investigators postulate that use of bidirectional traction (superior and inferior directions) and feedback from a digital force gauge is associated with minimal lead displacement compared to conventional lead extraction. Lead displacement is an indirect risk factor for potentially fatal lead extraction complications
Primary Outcome
The primary objective of the study is to evaluate the effect of traction force as measured by a digital force gauge on fluoroscopic lead displacement during lead extraction procedures. The investigators hypothesize that the lead displacement on fluoroscopy will be less than 1 cm when the traction force is limited to less than 8 lb.
Interventions
- OTHER Force gauge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-12-20 |
| Est. Completion | 2020-12-10 |
| Phase | NA |
What the finished NCT03842124 record still lists
NCT03842124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Force gauge is the first listed.
NCT03842124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03842124 about?
NCT03842124 is a clinical study titled "Improving Safety of Lead Extraction Procedures by Traction Force Sensing". Death and vascular tears occur in up to 1% of the patients undergoing lead extraction procedures. These complications are due to abnormal force vectors during the procedure. The investigators postulate that use of bidirectional traction (superior and inferior directions) and feedback from a digital ...
What is the current status of trial NCT03842124?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2018-12-20. Estimated completion is 2020-12-10.
What interventions are being tested in trial NCT03842124?
The interventions under investigation include: Force gauge (OTHER).
Who is sponsoring clinical trial NCT03842124?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03842124's enrollment target sits among peer trials
22 1756th of 2000 higher than 239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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