Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Master Study of the EVIA DR-T/DR/SR-T/SR Pacemaker|
- Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) [ Time Frame: 1 month follow-up completed ] [ Designated as safety issue: No ]
atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude.
atrial threshold test: measurable automatically or manually.
- Complication Free Rate [ Time Frame: 1- and 3- month follow-up completed ] [ Designated as safety issue: Yes ]
Complication free rate (in %):
1 minus(the number of possibly pacemaker related complications divided by the number of patients)
|Study Start Date:||June 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|Experimental: Pacemaker therapy||
Device: EVIA Pacemaker
patient has standard indication for pacemaker therapy