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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00711893
First received: July 7, 2008
Last updated: March 11, 2013
Last verified: March 2013

July 7, 2008
March 11, 2013
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00711893 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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.
ICD and CRT-D
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
301
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   China,   France,   Germany,   Greece,   Latvia,   Netherlands,   Slovakia,   Spain,   Switzerland
 
NCT00711893
FASt-IBP 0408, feci 08/1644
No
Guidant Corporation
Guidant Corporation
Not Provided
Principal Investigator: Konrad Goehl, MD Klinikum Nuernberg
Guidant Corporation
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP