Improving Safety of Lead Extraction Procedures by Traction Force Sensing

Cardiac Implantable Electronic Device Infection Clinical Trial

Official title:

Improving Safety of Lead Extraction Procedures by Traction Force Sensing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842124
• Other study ID #: 18-007322
• Status: Completed
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: December 10, 2020

Study information

• Verified date: June 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Implantable Electronic Device Infection
• Cardiovascular Infections
• Communicable Diseases
• Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials