The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
This is a prospective, single-armed, multi-center U.S., Australian, Canadian, and European clinical investigation, designed to demonstrate the safety and effectiveness of the EASYTRAK EPI lead in humans.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
EASYTRAK EPI lead
Multiple Locations in the US
Saint Paul, Minnesota, United States
Chronic Pacing Thresholds at 3 Months
The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.
Time frame: 3 months
Chronic Pacing Impedances at 3 Months
The expected mean impedance is 500 Ohms.
Time frame: 3 months
Chronic Sensing Amplitudes at 3 Months
The expected mean is 10mV.
Time frame: 3 months
Lead-related Complication-free Rate at 3 Months
The estimated target value for this endpoint is 80%.
Time frame: 3 months
Lead Implant Time
The estimated target value for average implant time is 30 minutes. Unit of measure will be the time period needed for the implant.
Time frame: Implant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.