NCT00711893

Feature Assessment Study for Indications Based Programming

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 301 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

"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"

Conditions

• Ventricular Tachycardia
• Ventricular Flutter
• Ventricular Fibrillation
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Cognis 100-D, Teligen DR and VR 100 HE	Teligen is an implantable defibrillator for detection and termination of life threatening arrhythmias. Cognis includes in addition to these capabilities cardiac resynchronization therapy for patients having heart failure.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-07-09
• Last updated: 2017-02-23

Locations

28 sites across 11 countries: Austria, Belgium, China, France, Germany, Greece, Latvia, Netherlands, Slovakia, Spain, Switzerland