Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-03-08 @ 5:56 AM
Study NCT ID:
NCT00711893
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2008-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feature Assessment Study for Indications Based Programming
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Feature Assessment Study for Indications Based Programming
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FASt-IBP
Brief 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"
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"
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| feci 08/1644 | None | None | View |