Feature Assessment Study for Indications Based Programming (FASt-IBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00711893
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : February 23, 2017
Guidant Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation

July 7, 2008
July 9, 2008
February 23, 2017
June 2008
February 2010   (Final data collection date for primary outcome measure)
Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting [ Time Frame: 6 Months ]
Same as current
Complete list of historical versions of study NCT00711893 on Archive Site
- Degree of acceptance of IBP - Proportion parameters changed per patient - Differences between recommended and final programmed parameters - Total number of parameter changes from IBP recommendations - Frequency of changes made to a single parameter [ Time Frame: 6 Months ]
Same as current
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Feature Assessment Study for Indications Based Programming
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"
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients indicated for the implant of an cardioverter defibrillator or cardiac resynchronization defibrillator defibrillator.
  • Ventricular Tachycardia
  • Ventricular Flutter
  • Ventricular Fibrillation
  • Heart Failure
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.
Patients indicated for an implantable defibrillator or cardiac resynchronization defibrillator
Intervention: Device: Cognis 100-D, Teligen DR and VR 100 HE
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • indicated for implantation of an ICD or CRT-D device according local hospital implant criteria guidelines

    • Implanted or intended to be implanted with any CE-marked device approved for implant from the TELIGEN (single or dual chamber ICD) or COGNIS (CRT-D) family during first implant (no replacements)
    • Geographically stable patients who are available for follow-up at a study centre
    • Age 18 or above, or of legal age to give informed consent specific to national law

Exclusion Criteria:

Inability or refusal to sign the Patient Informed Consent

  • Pregnant or planning to become pregnant
  • Replacement device
  • Enrolment in another clinical trial, study or evaluation
  • Estimated life expectancy of less than six months per discretion of physician
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   China,   France,   Germany,   Greece,   Latvia,   Netherlands,   Slovakia,   Spain,   Switzerland
FASt-IBP 0408
feci 08/1644
Not Provided
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Guidant Corporation
Principal Investigator: Konrad Goehl, MD Klinikum Nuernberg
Boston Scientific Corporation
February 2017