CompletedNot Applicable

Improving Safety of Lead Extraction Procedures by Traction Force Sensing

United States22 participantsStarted 2018-12-20

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: • Patients with CIED infection requiring extraction Exclusion criteria: * Age \<18 years * Noninfectious reasons for extraction * Patients with cognitive impairment, who are unable to consent.

What they're measuring

Fluoroscopic lead displacement

Timeframe: Intra-procedure measurements

Trial details

NCT IDNCT03842124

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-10

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