Status:
COMPLETED
Improving Safety of Lead Extraction Procedures by Traction Force Sensing
Lead Sponsor:
Mayo Clinic
Conditions:
Cardiac Implantable Electronic Device Infection
Cardiovascular Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 postulat...
Detailed Description
Use of force no greater than 8 pounds of tension will improve lead extraction and minimize lead displacement compared to current standard of care methods which do not limit the force applied. Among su...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03842124
Start Date
December 20 2018
End Date
December 10 2020
Last Update
June 23 2022
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905