Heart Failure Clinical Trial
Official title:
Feature Assessment Study for Indications Based Programming
The purpose of this evaluation is to assess the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications when using the feature 'Indications Based Programming' (IBP) available in the ZOOMVIEW Software Application for the TELIGEN DR / VR and COGNIS family of devices compared to daily life programming chosen by physicians.
"This study will focus on documenting the final parameter changes that are made in
comparison to the IBP recommendations for a specific cardiovascular and arrhythmia history.
It will therefore compare the device settings that were finally programmed during the last
available follow up procedure to the last available parameter recommendations of IBP. IBP
was designed to facilitate programming by providing customized parameter settings based on a
patient's clinical needs and primary indication.
In order to further enhance the IBP feature for future device generations, additional data
may be collected and evaluated on:
- Physician perception and satisfaction with the New User Interface (NUI) of the
programming application;
- Motivation for adapting IBP recommendations for the final programming of the device;
- Device data that can be retrieved from patient data disks that may include but is not
limited to, arrhythmia episode detail, pacing counter data; total and individual
therapy data"
;
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