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Improving Safety of Lead Extraction Procedures by Traction Force Sensing

NCT03842124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-06-23

No results posted yet for this 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

Conditions

  • Cardiac Implantable Electronic Device Infection
  • Cardiovascular Infections

Interventions

OTHER

Force gauge

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.

Sponsors & Collaborators

Principal Investigators

  • Siva K Mulpuru, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2020-12-10
Completion
2020-12-10

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03842124 on ClinicalTrials.gov