Feature Assessment Study for Indications Based Programming (FASt-IBP)
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| ClinicalTrials.gov Identifier: NCT00711893 |
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Recruitment Status
:
Completed
First Posted
: July 9, 2008
Last Update Posted
: February 23, 2017
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Sponsor:
Boston Scientific Corporation
Collaborator:
Guidant Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Ventricular Tachycardia Ventricular Flutter Ventricular Fibrillation Heart Failure | Device: Cognis 100-D, Teligen DR and VR 100 HE |
"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 |
| Actual Enrollment : | 301 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Feature Assessment Study for Indications Based Programming |
| Study Start Date : | June 2008 |
| Actual Primary Completion Date : | February 2010 |
| Actual Study Completion Date : | February 2010 |
| Group/Cohort | Intervention/treatment |
|---|---|
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ICD and CRT-D
Patients indicated for an implantable defibrillator or cardiac resynchronization defibrillator
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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.
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Primary Outcome Measures
:
- Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting [ Time Frame: 6 Months ]
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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Boston Scientific Corporation
Guidant Corporation
Investigators
| Principal Investigator: | Konrad Goehl, MD | Klinikum Nuernberg |
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00711893 History of Changes |
| Other Study ID Numbers: |
FASt-IBP 0408 feci 08/1644 |
| First Posted: | July 9, 2008 Key Record Dates |
| Last Update Posted: | February 23, 2017 |
| Last Verified: | February 2017 |
Additional relevant MeSH terms:
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Heart Failure Tachycardia Tachycardia, Ventricular Ventricular Fibrillation Ventricular Flutter |
Heart Diseases Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes |