The purpose of this clinical investigation is to assess the programming behavior of the physicians in the patient cohort. Furthermore, the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications will be evaluated by comparing parameters determined by the feature IBP to daily life programming chosen by physicians.
Study Type
OBSERVATIONAL
Enrollment
235
Observational investigation, only procedures according to local hospital standard.
Proportion of patients that are programmed by the physician to anything other than the specific IBP parameter settings
The primary endpoint is the proportion of patients that are programmed by the physician to anything other than the specific IBP parameter settings determined for the particular patient. The specific IBP parameter set is determined either by the physician using the IBP feature or by creating the most appropriate set of IBP parameters using the information given in the patient history section of the CRF. Each IBP recommended parameter will be evaluated individually.
Time frame: Enrollment / Last available follow up during the first six months after implant
Degree of acceptance of IBP
Measured by a composite endpoint on a 0 to 100 scale, reflecting all parameter changes for each patient between the IBP recommended parameter set and finally programmed parameter set of the last recorded visit. The impact on the endpoint will vary by the parameter reprogrammed. Weights will be determined for each parameter based upon the relevance of the parameter to the overall acceptance of the IBP algorithm.
Time frame: Enrollment / Last available follow up during the first six months after implant
Proportion of patients without any IBP use
Time frame: First six months after implant.
Proportion of patients without any IBP use at enrollment, but IBP use during follow up.
Time frame: First six months after implant.
Proportion of patients with IBP use only at enrollment.
Time frame: First six months after implant.
oProportion of patients with IBP use during enrollment and additional subsequent use of IBP during follow up.
Time frame: First six months after implant.
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Social Insurance Chukyo Hospital
Nagoya, Aichi-ken, Japan
Hiraka General Hospital
Yokote, Akita, Japan
Kameda Medical Hospital
Kamogawa, Chiba, Japan
Shin-Tokyo Hospital
Matsudo, Chiba, Japan
Juntendo University Urayasu Hospital
Urayasu, Chiba, Japan
Saiseikai Imabari Hospital
Imabari, Ehime, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Aso Iizuka Hospital
Iizuka, Fukuoka, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Shinkoga Hospital
Kurume, Fukuoka, Japan
...and 35 more locations
Proportion of parameters changed per patient from nominal device settings.
Time frame: First six months after implant.
Proportion of parameters changed per patient from IBP recommended device settings, if IBP was used.
Time frame: First six months after implant.
Differences between nominal parameters and final programming by physicians for parameters with quantitative values.
Time frame: First six months after implant.
Differences between parameters recommended by IBP and final programming by physicians for parameters with quantitative values
Time frame: First six months after implant.
Total number of parameter changes recorded during the enrollment procedure after IBP recommendations were programmed.
Time frame: First six months after implant.
Total number of parameter changes to a value different from the device nominals recorded during the enrollment procedure
Time frame: First six months after implant.
oTotal number of parameter changes during follow up procedure(s)
Time frame: First six months after implant.
Frequency of changes made to a single parameter during the time the patient is enrolled in the clinical investigation.
Time frame: First six months after implant.