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| ID | Type | Description | Link |
|---|---|---|---|
| feci 08/1644 |
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| Name | Class |
|---|---|
| Guidant Corporation | INDUSTRY |
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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.
"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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD and CRT-D | Patients indicated for an implantable defibrillator or cardiac resynchronization defibrillator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognis 100-D, Teligen DR and VR 100 HE | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting | 6 Months |
| Measure | Description | 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 | 6 Months |
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Inclusion Criteria:
indicated for implantation of an ICD or CRT-D device according local hospital implant criteria guidelines
Exclusion Criteria:
Inability or refusal to sign the Patient Informed Consent
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Patients indicated for the implant of an cardioverter defibrillator or cardiac resynchronization defibrillator defibrillator.
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| Name | Affiliation | Role |
|---|---|---|
| Konrad Goehl, MD | Klinikum Nuernberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KH der Elisabethinen Linz | Linz | 4010 | Austria | |||
| KH der Barmherzigen Schwestern Ried/Innkreis |
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| Ried |
| 4910 |
| Austria |
| Hartcentrum Hasselt - Dienst Cardiologie | Hasselt | 3500 | Belgium |
| Prince of Wales Hospital | Hong Kong | Hong Kong | China |
| EHRU de Brest - Hospital de la Cavale Blanche | Brest | 29200 | France |
| CHU Dijon - Hospital du Bocage | Dijon | 21000 | France |
| CHR Orléans - Hospital la Source | Orléans | 45067 | France |
| CMC Parly II | Parly | 78000 | France |
| CHU de St. Etienne-Hospital Nord | Saint-Priest-en-Jarez | 42055 | France |
| CHU de Tours | Tours | 37044 | France |
| Kerckhoff-Klinik GmbH | Bad Nauheim | 61231 | Germany |
| Praxis Dres. Bischoff/Lang | Erfurt | 99084 | Germany |
| Klinikum Fulda | Fulda | 36043 | Germany |
| Marienhospital Herne | Herne | 44625 | Germany |
| Klinikum Kassel | Kassel | 34125 | Germany |
| Praxis Schnabel der Praxisgemeinschaft Kardiologie Meissen | Meissen | 01662 | Germany |
| Klinikum Nuernberg | Nuremberg | 90471 | Germany |
| Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH | Quedlinburg | 06484 | Germany |
| University Hospital of Heraklion | Heraklion | 71409 | Greece |
| Paul Stradina Clinical University Hospital | Riga | 1002 | Latvia |
| Ziekenhius Rijnstate Arnhem | Arnhem | 6815 | Netherlands |
| Amphia Ziekenhius Breda | Breda | 4818 | Netherlands |
| Narodny ustav srdcvych a cievnych chorob | Bratislava | 83348 | Slovakia |
| Hospital Universitario Central de Asturias | Oviedo | 33006 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | 07004 | Spain |
| Clinico Universitario de Valladolid | Valladolid | 47005 | Spain |
| Centro Miguel Servet | Zaragoza | 50012 | Spain |
| University Hospital of Geneva | Geneva | 1211 | Switzerland |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D054141 | Ventricular Flutter |
| D014693 | Ventricular Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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