Safety and Efficacy Study of RENEWAL 4 AVT
The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CONTAK RENEWAL 4 AVT Field Following|
- 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
|Study Start Date:||July 2004|
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.