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About
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
Patients who meet the EASYTRAK EPI indications
Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
Patients who meet any one of the following three conditions:
Exclusion criteria
Primary purpose
Allocation
Interventional model
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100 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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