Feature Assessment Study for Indications Based Programming
- Conditions
- Ventricular TachycardiaVentricular FlutterVentricular FibrillationHeart Failure
- Interventions
- Device: Cognis 100-D, Teligen DR and VR 100 HE
- Registration Number
- NCT00711893
- Lead Sponsor
- Boston Scientific Corporation
- 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.
- 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"
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 301
-
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
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ICD and CRT-D Cognis 100-D, Teligen DR and VR 100 HE Patients indicated for an implantable defibrillator or cardiac resynchronization defibrillator
- Primary Outcome Measures
Name Time Method Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting 6 Months
- Secondary Outcome Measures
Name Time Method - 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
Trial Locations
- Locations (28)
Prince of Wales Hospital
🇨🇳Hong Kong, Hong Kong, China
Hartcentrum Hasselt - Dienst Cardiologie
🇧🇪Hasselt, Belgium
CHU Dijon - Hospital du Bocage
🇫🇷Dijon, France
CMC Parly II
🇫🇷Parly, France
Kerckhoff-Klinik GmbH
🇩🇪Bad Nauheim, Germany
Praxis Dres. Bischoff/Lang
🇩🇪Erfurt, Germany
Marienhospital Herne
🇩🇪Herne, Germany
Klinikum Kassel
🇩🇪Kassel, Germany
Praxis Schnabel der Praxisgemeinschaft Kardiologie Meissen
🇩🇪Meissen, Germany
Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH
🇩🇪Quedlinburg, Germany
Paul Stradina Clinical University Hospital
🇱🇻Riga, Latvia
University Hospital of Heraklion
🇬🇷Heraklion, Greece
Ziekenhius Rijnstate Arnhem
🇳🇱Arnhem, Netherlands
Narodny ustav srdcvych a cievnych chorob
🇸🇰Bratislava, Slovakia
Amphia Ziekenhius Breda
🇳🇱Breda, Netherlands
Hospital Son Llatzer
🇪🇸Palma de Mallorca, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain
University Hospital of Geneva
🇨🇭Geneva, Switzerland
CHU de Tours
🇫🇷Tours Cedex, France
EHRU de Brest - Hospital de la Cavale Blanche
🇫🇷Brest, France
Klinikum Nuernberg
🇩🇪Nuernberg, Germany
CHR Orléans - Hospital la Source
🇫🇷Orléans, France
CHU de St. Etienne-Hospital Nord
🇫🇷Saint Priest en Jarez, France
Centro Miguel Servet
🇪🇸Zaragoza, Spain
Klinikum Fulda
🇩🇪Fulda, Germany
KH der Barmherzigen Schwestern Ried/Innkreis
🇦🇹Ried, Austria
KH der Elisabethinen Linz
🇦🇹Linz, Austria