Implant Site Infection Clinical Trial
Prospective, Investigational Study to Assess the Safety and Performance of LeadExx LC System in Lead Extraction
The study's main purpose is to evaluate the safety and performance of the LeadExx LC System
and its ability to safely extract leads.
The study will enroll 10 patients scheduled for CIED lead extraction. The decision upon lead extraction will be based upon the applicable Heart Rhythm Society guidelines or European Heart Rhythm Association (EHRA).
The use of implantable cardiac devices has been exponentially increasing, and lead
extraction has become a necessary procedure. But lead extraction has potentially serious
complications, including venous or myocardial tear, cardiac tamponade, and even death.
Powered sheaths, such as Excimer laser or a radiofrequency system, have been used for
extraction of ICD or pacemaker leads. However, the Heart Rhythm Society (HRS) has stated
that "possible predictors of major complications were implant duration of the oldest lead,
female gender, ICD lead removal, and use of the laser extraction technique, multiple leads,
and calcified leads".
To reduce the risk of the lead extraction procedure and therefore reduce the number of abandoned leads, LeadExx had developed its system.
The LC system is an active disposable system provided sterile for single use. The system is comprised of the following two main parts:
a. Dilation Unit (DU) - (invasive, sterile) b. Control Unit- (CU) - (non-invasive, sterile fluid path) The physical connection between the units is achieved by 3 Luer locks that connect the CU Solenoids' output to 3 flexible tubes at the proximal end of the DU.
1. Dilation Unit (DU):
The dilation unit is an invasive sterile unit, comprised of a dilation tip and a connecting shaft. The unit is activated using a hydraulic mechanism.
The dilation tip is threaded over the lead, inserted into the vessel together with its connecting shaft and while advancing along the lead, dilates the surrounding tissue and ultimately enables the lead removal from the vein.
2. Control Unit (CU):
The Control Unit is a non-invasive fluid path sterile unit, comprised of various off the shelf modules . The unit is being filled with sterile Saline just prior to its operation and by synchronizing the transfer of the Saline into the DU controls its advancement. I ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment