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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00711893
Other study ID # FASt-IBP 0408
Secondary ID feci 08/1644
Status Completed
Phase N/A
First received July 7, 2008
Last updated February 17, 2017
Start date June 2008
Est. completion date February 2010

Study information

Verified date February 2017
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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"


Recruitment information / eligibility

Status Completed
Enrollment 301
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Austria KH der Elisabethinen Linz Linz
Austria KH der Barmherzigen Schwestern Ried/Innkreis Ried
Belgium Hartcentrum Hasselt - Dienst Cardiologie Hasselt
China Prince of Wales Hospital Hong Kong Hong Kong
France EHRU de Brest - Hospital de la Cavale Blanche Brest
France CHU Dijon - Hospital du Bocage Dijon
France CHR Orléans - Hospital la Source Orléans
France CMC Parly II Parly
France CHU de St. Etienne-Hospital Nord Saint Priest en Jarez
France CHU de Tours Tours Cedex
Germany Kerckhoff-Klinik GmbH Bad Nauheim
Germany Praxis Dres. Bischoff/Lang Erfurt
Germany Klinikum Fulda Fulda
Germany Marienhospital Herne Herne
Germany Klinikum Kassel Kassel
Germany Praxis Schnabel der Praxisgemeinschaft Kardiologie Meissen Meissen
Germany Klinikum Nuernberg Nuernberg
Germany Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH Quedlinburg
Greece University Hospital of Heraklion Heraklion
Latvia Paul Stradina Clinical University Hospital Riga
Netherlands Ziekenhius Rijnstate Arnhem Arnhem
Netherlands Amphia Ziekenhius Breda Breda
Slovakia Narodny ustav srdcvych a cievnych chorob Bratislava
Spain Hospital Universitario Central de Asturias Oviedo
Spain Hospital Son Llatzer Palma de Mallorca
Spain Clinico Universitario de Valladolid Valladolid
Spain Centro Miguel Servet Zaragoza
Switzerland University Hospital of Geneva Geneva

Sponsors (2)

Lead Sponsor Collaborator
Boston Scientific Corporation Guidant Corporation

Countries where clinical trial is conducted

Austria,  Belgium,  China,  France,  Germany,  Greece,  Latvia,  Netherlands,  Slovakia,  Spain,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting 6 Months
Secondary - 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 6 Months
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