Heart Failure Clinical Trial
— FASt-IBPOfficial title:
Feature Assessment Study for Indications Based Programming
Verified date | February 2017 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation | Guidant Corporation |
Austria, Belgium, China, France, Germany, Greece, Latvia, Netherlands, Slovakia, Spain, Switzerland,
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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