The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.
This is a prospective, two-arm, non-randomized, multi-center European field following, designed to demonstrate the safety and effectiveness of the CONTAK RENEWAL 4 AVT device in humans.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Kerckhof Klinik
Bad Nauheim, Germany
System Complication-Free Rate at 6 months
Effectiveness of LV Only/LV Offset at 6 months
LVESD at 6 months
Six-minute walk at 6 months
NYHA at 6 months
QOL at 6 months
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