Improving Safety of Lead Extraction Procedures by Traction Force Sensing

NCT03842124 | Completed

• 1 other identifier: 18-007322
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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 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

Keywords

infection; pacemaker; ICD; CRT

Outcome Measures

Primary Outcomes (1)

• Fluoroscopic lead displacement

  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.

  Intra-procedure measurements

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Use of bidirectional rail (superior and inferior approaches) and force sensing using a force gauge to optimize Force application to less than 8 lbs during the extraction procedure.

Other: Force gauge

Control

NO INTERVENTION

Conventional lead extraction procedures using a superior approach is performed by experienced operators. Although force information is available the operators are blinded to the information. Inferior rail is left to the discretion of the operator.

Interventions

Force gauge OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with CIED infection requiring extraction

You may not qualify if:

• Age \<18 years
• Noninfectious reasons for extraction
• Patients with cognitive impairment, who are unable to consent.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Cardiovascular Infections; Infections

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Siva K Mulpuru, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is randomized such that the same operator can be doing the extraction with force gauge with or without the force information.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: February 15, 2019
• Study Start: December 20, 2018
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

US (1)