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
  Purpose

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.


Condition Intervention
Ventricular Tachycardia
Ventricular Flutter
Ventricular Fibrillation
Heart Failure
Device: Cognis 100-D, Teligen DR and VR 100 HE

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feature Assessment Study for Indications Based Programming

Resource links provided by NLM:


Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • - 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 ]

Enrollment: 301
Study Start Date: June 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ICD and CRT-D
Patients indicated for an implantable defibrillator or cardiac resynchronization defibrillator
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.

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"
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients indicated for the implant of an cardioverter defibrillator or cardiac resynchronization defibrillator defibrillator.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711893

Locations
Austria
KH der Elisabethinen Linz
Linz, Austria, 4010
KH der Barmherzigen Schwestern Ried/Innkreis
Ried, Austria, 4910
Belgium
Hartcentrum Hasselt - Dienst Cardiologie
Hasselt, Belgium, 3500
China, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong, China
France
EHRU de Brest - Hospital de la Cavale Blanche
Brest, France, 29200
CHU Dijon - Hospital du Bocage
Dijon, France, 21000
CHR Orléans - Hospital la Source
Orléans, France, 45067
CMC Parly II
Parly, France, 78000
CHU de St. Etienne-Hospital Nord
Saint Priest en Jarez, France, 42055
CHU de Tours
Tours Cedex, France, 37044
Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany, 61231
Praxis Dres. Bischoff/Lang
Erfurt, Germany, 99084
Klinikum Fulda
Fulda, Germany, 36043
Marienhospital Herne
Herne, Germany, 44625
Klinikum Kassel
Kassel, Germany, 34125
Praxis Schnabel der Praxisgemeinschaft Kardiologie Meissen
Meissen, Germany, 01662
Klinikum Nuernberg
Nuernberg, Germany, 90471
Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH
Quedlinburg, Germany, 06484
Greece
University Hospital of Heraklion
Heraklion, Greece, 71409
Latvia
Paul Stradina Clinical University Hospital
Riga, Latvia, 1002
Netherlands
Ziekenhius Rijnstate Arnhem
Arnhem, Netherlands, 6815
Amphia Ziekenhius Breda
Breda, Netherlands, 4818
Slovakia
Narodny ustav srdcvych a cievnych chorob
Bratislava, Slovakia, 83348
Spain
Hospital Universitario Central de Asturias
Oviedo, Spain, 33006
Hospital Son Llatzer
Palma de Mallorca, Spain, 07004
Clinico Universitario de Valladolid
Valladolid, Spain, 47005
Centro Miguel Servet
Zaragoza, Spain, 50012
Switzerland
University Hospital of Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: Konrad Goehl, MD Klinikum Nuernberg
  More Information

No publications provided

Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00711893     History of Changes
Other Study ID Numbers: FASt-IBP 0408, feci 08/1644
Study First Received: July 7, 2008
Last Updated: March 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Ventricular Flutter
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014