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

February 17, 2017 updated by: Boston Scientific Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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"

Study Type

Observational

Enrollment (Actual)

301

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
- 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
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

Guidant Corporation

Investigators

  • Principal Investigator: Konrad Goehl, MD, Klinikum Nuernberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 7, 2008

First Posted (Estimate)

July 9, 2008

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FASt-IBP 0408
  • feci 08/1644

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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