Improving Safety of Lead Extraction Procedures by Traction Force Sensing

June 21, 2022 updated by: Siva Mulpuru, Mayo Clinic
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 subjects undergoing lead extraction procedures for CIED infection, bidirectional rail (superior and inferior) and traction force objective feedback using Force gauge is associated with minimal displacement (<1cm) of the leads (surrogate marker) on fluoroscopy compared to conventional lead extraction. • The research nature of the protocol is explicitly explained to the patient and an informed consent is explained obtained from the patient prior to the procedure. Only patients with CIED infections requiring lead extraction are enrolled in the study. Patients are risk stratified based on our current risk stratifications scheme. Multiple superior and inferior venous accesses are obtained during the procedure. The leads are prepared using locking stylets. Baseline fluoroscopic image of the position of the leads is stored. A deflectable sheath and traction forceps are deployed from the groin to provide downward rail in the force feedback arm. Locking stylet from the lead is in turn attached to a Force gauge (McMaster-Carr Santa Fe Springs, CA). The procedure is performed using continuous fluoroscopic image save tool during the procedure for post procedural viewing and analysis. The patients are randomized to the active arm (to keep force around 8 lb) or the control arm (tactile force discretion based on the operator. The investigator is blinded to the force gauge reading for half of the patients enrolled in the study. For the other half of the patients, the operator optimizes the force to prevent overexertion (<8-9 pounds). Three point along the lead course evaluated during the study. Position of downward turn of the lead in the SVC, heel of the lead (only in case of RV lead) and the lead tip positions are evaluated. The investigators postulate that there will be at least 5 cine-fluoroscopic views per every lead. The investigators hypothesize that use of bidirectional rail and force feedback is associated with minimal displacement of the lead on fluoroscopy.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
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
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.
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluoroscopic lead displacement
Time Frame: Intra-procedure measurements
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Siva K Mulpuru, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2018

Primary Completion (Actual)

December 10, 2020

Study Completion (Actual)

December 10, 2020

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-007322

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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