An interventional study of Force gauge in Cardiac Implantable Electronic Device Infection and Cardiovascular Infections, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Other
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
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.
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Exclusion criteria:
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
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.
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.
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.
Time frame: Intra-procedure measurements
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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