An observational study in Heart Failure and Arrhythmias, Cardiac, sponsored by Boston Scientific Corporation. Completed at 45 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Boston Scientific Corporation · Observational
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 235 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
The patient population comprises the standard patient population of the participating sites indicated for the intended devices per local guidelines in the study centers.
Exclusion Criteria:
Patients implanted with a single or dual chamber ICD or CRT-D device approved in Japan capable of using the IBP feature.
Other: No specific interventions
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.
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.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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