The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.
This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
EASYTRAK 3 Downsize Lead
Multiple Locations
Saint Paul, Minnesota, United States
Lead-related complication-free rate at one-month
Time frame: 1 month
Chronic mean pacing thresholds at one-month.
Time frame: 1 month
Chronic mean R-wave amplitudes at one-month
Time frame: 1 month
Chronic mean pacing impedances at one-month.
Time frame: 1 month
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